[Federal Register: July 21, 2000 (Volume 65, Number 141)] [Notices] [Page 45427-45510] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr21jy00-120] [[Page 45427]] ----------------------------------------------------------------------- Part II Department of Health and Human Services ----------------------------------------------------------------------- Food and Drug Administration ----------------------------------------------------------------------- Annual Comprehensive List of Guidance Documents at the Food and Drug Administration; Notice [[Page 45428]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0046] Annual Comprehensive List of Guidance Documents at the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing an annual comprehensive list of all guidance documents currently in use at the agency. We committed to publishing this list in our February 1997 ``Good Guidance Practices'' (GGP's), which set forth our policies and procedures for developing, issuing, and using guidance documents. This list is intended to inform the public of the existence and availability of all our current guidance documents. DATES: We welcome general comments on this list and on agency guidance documents at any time. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. We have provided information on where to obtain a single copy of any of the guidance documents listed in the specific Center's list of guidance documents. FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 27, 1997 (62 FR 8961), we announced our GGP's--our policies and procedures for developing, issuing, and using guidance documents. We adopted the GGP's to ensure your involvement in the development of guidance documents and to enhance your understanding of the availability, nature, and legal effect of such guidance. As part of our effort to ensure meaningful interaction with the public regarding guidance documents, we committed to publish an annual comprehensive list of guidance documents and quarterly updates that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents. A. Plain Language in Guidance Documents On June 1, 1998, the President instructed all Federal agencies to ensure the use of ``plain language'' in all new documents. As part of this initiative, We use the principles of ``plain language'' set forth by the President when writing our guidance documents. We seek your comments on the clarity of our guidances. B. How the List is Organized The following comprehensive list of guidance documents represents all guidances currently in effect. This comprehensive list is maintained on the FDA Internet home page. We will update and publish this list in the Federal Register every year. We organized the guidance documents in this comprehensive list by the issuing Center or Office within FDA, and we further grouped them by the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. We also provide document numbers when they are available. II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER) -------------------------------------------------------------------------------------------------------------------------------------------------------- Grouped by Intended User or Name of Document Date of Issuance Regulatory Activity How to Obtain a Hard Copy of the Document -------------------------------------------------------------------------------------------------------------------------------------------------------- Interpretative Guidelines of the Source Plasma October 2, 1973 FDA Regulated Industry Office of Communication, Training, and (Human) Standards Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888- CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Reviewing Amendments to Include July 20, 1976 Do Do Plasmapheresis of Hemophiliacs -------------------------------------------------------------------------------------------------------------------------------------------------------- Package Insert: Immune Serum Globulin (Human) March 30, 1978 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Interpretation of Potency Test April 12, 1979 Do Do Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Immunization of Source Plasma June 1, 1980 Do Do (Human) Donors with Blood Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- Collection of Human Leukocytes for Further January 28, 1981 Do Do Manufacturing (Source Leukocytes) -------------------------------------------------------------------------------------------------------------------------------------------------------- Platelet Testing Guidelines--Approval of New July 1, 1981 Do Do Procedures and Equipment -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45429]] Revised Guideline for Adding Heparin to Empty August 1, 1981 Do Do Containers for Collection of Heparinized Source Plasma (Human) -------------------------------------------------------------------------------------------------------------------------------------------------------- Requirements for Infrequent Plasmapheresis August 27, 1982 Do Do Donors -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations to Decrease the Risk of March 24, 1983 Do Do Transmitting AIDS from Plasma Donors -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Manufacture of In Vitro Monoclonal June 20, 1983 Do Do Antibody Products Subject to Licensure -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft PTC in the Production and Testing of July 28, 1983 Do Do Interferon Intended for Investigational Use in Humans (Interferon Test Procedures) -------------------------------------------------------------------------------------------------------------------------------------------------------- Interstate Shipment of Interferon for November 21, 1983 Do Do Investigational Use in Laboratory Research Animals or Tests in Vitro -------------------------------------------------------------------------------------------------------------------------------------------------------- Deferral of Blood Donors Who Have Received the February 28, 1984 Do Do Drug Accutane (isotretinoin/Roche); 13-cis- retinoic acid) -------------------------------------------------------------------------------------------------------------------------------------------------------- Equivalent Methods for Compatibility Testing December 14, 1984 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Plasma Derived from Therapeutic Plasma Exchange December 14, 1984 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft PTC in the Production and Testing of New April 10, 1985 Do Do Drugs and Biologicals Produced by Recombinant DNA Technology -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Meningococcal Polysaccharide July 17, 1985 Do Do Vaccines -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for the Uniform Labeling of Blood and August 1, 1985 Do Do Blood Components -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommended Methods for Short Ragweed Pollen November 1, 1985 Do Do Extracts -------------------------------------------------------------------------------------------------------------------------------------------------------- Reduction of the Maximum Platelet Storage June 2, 1986 Do Do Period to 5 Days in an Approved Container -------------------------------------------------------------------------------------------------------------------------------------------------------- To In Vitro Diagnostic Reagent Manufacturers: December 6, 1986 Do Do Guidance On the Labeling of Human Blood Derived In Vitro Diagnostic Devices In Regard to Labeling for HTLV-III/LAV Antibody Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for Submitting Documentation for the February 1, 1987 Do Do Stability of Human Drugs and Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for Submitting Documentation for February 1, 1987 Do Do Packaging for Human Drugs and Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline On General Principles of Process May 1, 1987 Do Do Validation -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline On Sterile Drug Products Produced by June 1, 1987 Do Do Aseptic Processing -------------------------------------------------------------------------------------------------------------------------------------------------------- Deferral of Donors Who Have Received Human November 25, 1987 Do Do Pituitary-Derived Growth Hormone -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45430]] Guideline On Validation of the Limulus December 1, 1987 Do Do Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for the Management of Donors December 2, 1987 Do Do and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) -------------------------------------------------------------------------------------------------------------------------------------------------------- Extension of Dating Period for Storage of Red December 4, 1987 Do Do Blood Cells, Frozen -------------------------------------------------------------------------------------------------------------------------------------------------------- To Licensed In-Vitro Diagnostic Manufacturers: December 23, 1987 Do Do Handling of Human Blood Source Materials -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for Implementation of April 6, 1988 Do Do Computerization in Blood Establishments -------------------------------------------------------------------------------------------------------------------------------------------------------- Control of Unsuitable Blood and Blood April 6, 1988 Do Do Components -------------------------------------------------------------------------------------------------------------------------------------------------------- Discontinuance of Prelicensing Inspection for July 7, 1988 Do Do Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines -------------------------------------------------------------------------------------------------------------------------------------------------------- Physician Substitutes August 15, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- To Licensed Manufacturers of Blood Grouping August 26, 1988 Do Do Reagents: Criteria for Exemption of Lot Release -------------------------------------------------------------------------------------------------------------------------------------------------------- Revised Guideline for the Collection of October 7, 1988 Do Do Platelets, Pheresis -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers of HTLV-I Antibody Test Kits: October 18, 1988 Do Do Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guideline for the Design of Clinical November 1, 1988 Do Do Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses -------------------------------------------------------------------------------------------------------------------------------------------------------- HTLV-1 Antibody Testing November 29, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Use of Recombigen HIV-1 LA Test February 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Release of Pneumococcal Vaccine, February 1, 1989 Do Do Polyvalent -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Autologous Blood and Blood March 15, 1989 Do Do Components -------------------------------------------------------------------------------------------------------------------------------------------------------- HTLV-I Antibody Testing July 6, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Use of Recombigen HIV-1 Latex Agglutination August 1, 1989 Do Do (LA) Test -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft PTC in the Manufacture and Clinical August 8, 1989 Do Do Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989) -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Collection, Processing and Testing August 22, 1989 Do Do of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45431]] Information Relevant to the Manufacture of August 23, 1989 Do Do Acellular Pertussis Vaccine -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Regulated Industries for Drug Master Files September 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Requirements for Computerization of Blood September 8, 1989 Do Do Establishments -------------------------------------------------------------------------------------------------------------------------------------------------------- Abbott Laboratories' HIVAG-1 Test for HIV-1 October 4, 1989 Do Do Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for Collection of Blood or Blood October 26, 1989 Do Do Products from Donors With Positive Tests for Infectious Disease Markers (``High Risk'' Donors) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for Determination of Residual January 1, 1990 Do Do Moisture in Dried Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Autologous Blood Collection and Processing February 12, 1990 Do Do Procedures -------------------------------------------------------------------------------------------------------------------------------------------------------- Cytokine and Growth Factor Pre-Pivotal Trial April 2, 1990 Do Do Information Package -------------------------------------------------------------------------------------------------------------------------------------------------------- Use of Genetic Systems HIV-2 EIA June 21, 1990 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Safety Evaluation of Hemoglobin- August 21, 1990 Do Do Based Oxygen Carriers -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline on the Preparation of Investigational March 1, 1991 Do Do New Drug Products (Human & Animal) -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Request for Information on Blood Storage March 15, 1991 Do Do Patterns and Red Cell Contamination by Yersinia Enterocolitica -------------------------------------------------------------------------------------------------------------------------------------------------------- Revision to October 26, 1989 Guideline for March 17, 1991 Do Do Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (High Risk Donors) -------------------------------------------------------------------------------------------------------------------------------------------------------- Deficiencies Relating to the Manufacture of March 20, 1991 Do Do Blood and Blood Components -------------------------------------------------------------------------------------------------------------------------------------------------------- Responsibilities of Blood Establishments March 20, 1991 Do Do Related to Errors & Accidents in the Manufacture of Blood and Blood Components -------------------------------------------------------------------------------------------------------------------------------------------------------- To Biologic Product Manufacturers--Controlling May 3, 1991 Do Do Materials of Bovine or Ovine Origin -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Recommendations Concerning Testing for September 10, 1991 Do Do Antibody to Hepatitis B Core Antigen (Anti- HBc) -------------------------------------------------------------------------------------------------------------------------------------------------------- Disposition of Blood Products Intended for September 11, 1991 Do Do Autologous Use That Test Repeatedly Reactive for Anti-HCV -------------------------------------------------------------------------------------------------------------------------------------------------------- Clarification of FDA Recommendations for Donor December 12, 1991 Do Do Deferral and Product Distribution Based on the Results of Syphilis Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommended Methods for Blood Grouping Reagents March 1, 1992 Do Do Evaluation -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45432]] Recommended Methods for Evaluating Potency, March 1, 1992 Do Do Specificity and Reactivity of Anti-Human Globulin -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Design and Implementation of Field March 1, 1992 Do Do Trials for Blood Grouping Reagents and Anti- Human Globulin -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Manufacture of In Vitro Monoclonal March 1, 1992 Do Do Antibody Products for Further Manufacturing into Blood Grouping Reagents and Anti-Human Globulin -------------------------------------------------------------------------------------------------------------------------------------------------------- Supplement to the PTC in the Production and April 6, 1992 Do Do Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability -------------------------------------------------------------------------------------------------------------------------------------------------------- Revised Recommendations for the Prevention of April 23, 1992 Do Do Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Use of Fluorognost HIV-1 Immunofluorescent April 23, 1992 Do Do Assay (IFA) -------------------------------------------------------------------------------------------------------------------------------------------------------- Revised Recommendations for Testing Whole April 23, 1992 Do Do Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) -------------------------------------------------------------------------------------------------------------------------------------------------------- Exemptions to Permit Persons with a History of April 23, 1992 Do Do Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma; Alternative Procedures, 21 CFR 640.120 -------------------------------------------------------------------------------------------------------------------------------------------------------- Changes in Equipment for Processing Blood Donor July 21, 1992 Do Do Samples -------------------------------------------------------------------------------------------------------------------------------------------------------- Nomenclature for Monoclonal Blood Grouping September 28, 1992 Do Do Reagents -------------------------------------------------------------------------------------------------------------------------------------------------------- Volume Limits for Automated Collection of November 4, 1992 Do Do Source Plasma -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA's Policy Statement Concerning Cooperative November 25, 1992 Do Do Manufacturing Arrangements for Licensed Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Revision of October 7, 1988 Memo Concerning Red December 16, 1992 Do Do Blood Cell Immunization Programs -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft PTC in the Characterization of Cell Lines July 12, 1993 Do Do Used to Produce Biologicals -------------------------------------------------------------------------------------------------------------------------------------------------------- CBER Refusal to File (RTF) Guidance for Product July 12, 1993 Do Do and Establishment License Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- Alternatives to Lot Release July 20, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations Regarding License Amendments July 22, 1993 Do Do and Procedures for Gamma Irradiation of Blood Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Deferral of Blood and Plasma Donors based on July 28, 1993 Do Do Medications -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45433]] Revised Recommendations for Testing Whole August 19, 1993 Do Do Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) -------------------------------------------------------------------------------------------------------------------------------------------------------- Changes in administrative procedures September 9, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- To Sponsors of IND's using Retroviral Vectors September 20, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guideline for the Validation of Blood September 28, 1993 Do Do Establishment Computer Systems -------------------------------------------------------------------------------------------------------------------------------------------------------- Methods of the Allergenic Products Testing October 1, 1993 Do Do Laboratory -------------------------------------------------------------------------------------------------------------------------------------------------------- Application of Current Statutory Authorities to October 14, 1993 Do Do Human Somatic Cell Therapy Products and Gene Therapy Products; Notice -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for Adverse Experience Reporting for October 15, 1993 Do Do Licensed Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Regarding Post Donation Information December 10, 1993 Do Do Reports -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers: Bovine Derived Materials December 17, 1993 Do Do (BSE) -------------------------------------------------------------------------------------------------------------------------------------------------------- Donor Suitability Related to Laboratory Testing December 22, 1993 Do Do for Viral Hepatitis and a history of Viral Hepatitis -------------------------------------------------------------------------------------------------------------------------------------------------------- Compliance Program Guidance Manual (Drugs and 1994 Do National Technical Information Service (NTIS), Biologics) 5285 Port Royal Rd., Springfield, VA 22161, 703-605-6050, (Publication No. 94-920699) -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for the Invalidation of Test January 3, 1994 Do Office of Communication, Training, and Results When Using Licensed Viral Marker Manufacturers Assistance (HFM-40), Center for Assays to Screen Donors Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888- CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/cber -------------------------------------------------------------------------------------------------------------------------------------------------------- To Blood Establishment Computer Software March 31, 1994 Do Do Manufacturers -------------------------------------------------------------------------------------------------------------------------------------------------------- To Sponsors of IND's for Human Immunoglobulin May 23, 1994 Do Do Products -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers of Licensed Anti-HIV Test Kits May 26, 1994 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for Deferral of Donors for July 26, 1994 Do Do Malaria Risk -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline for Industry: Studies in Support August 1, 1994 Do Do of Special Populations -------------------------------------------------------------------------------------------------------------------------------------------------------- OELPS, Advertising and Promotional Labeling August 1, 1994 Do Do Staff Procedural Guidance Document (Draft) -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45434]] Use of and FDA Cleared or Approved Sterile August 5, 1994 Do Do Docking Device (STCD) in Blood Bank Practices (transmittal memo 8/12/94) (corrects 7/29/94 Memo) -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline for Industry: Stability Testing September 1, 1994 Do Do of New Drug Substances and Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guide to Inspections of Blood Banks, Division September 1, 1994 FDA Personnel Do of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter to Manufacturers of Immune Globulin October 3, 1994 FDA Regulated Industry Do Intravenous (Human)(IGIV), Aseptic Meningitis Syndrome -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance on Alternatives to Lot Release for October 27, 1994 Do Do Licensed Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: For the Submission of November 1994 Do Do Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations to Users of Medical Devices December 20, 1994 Do Do That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers of Immune Globulin Products: December 27, 1994 Do Do Testing for Hepatitis C Virus RNA Immunoglobulin -------------------------------------------------------------------------------------------------------------------------------------------------------- Timeframe for Licensing Irradiated Blood February 3, 1995 Do Do Products -------------------------------------------------------------------------------------------------------------------------------------------------------- To Blood Establishment Computer Software February 10, 1995 Do Do Manufacturers -------------------------------------------------------------------------------------------------------------------------------------------------------- Home Specimen Collection Kit Systems Intended February 23, 1995 Do Do for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline for Industry: Clinical Safety March 1, 1995 Do Do Data Management: Definitions and Standards for Expedited Reporting -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers of Intramuscular Immune March 3, 1995 Do Do Globulin Products: HCV RNA Testing by PCR -------------------------------------------------------------------------------------------------------------------------------------------------------- Revision of August 27, 1982 FDA Memo: March 10, 1995 Do Do Requirements for Infrequent Plasmapheresis Donors -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers of Intramuscular Immune March 13, 1995 Do Do Globulin Products: additional information regarding HCV RNA testing by PCR -------------------------------------------------------------------------------------------------------------------------------------------------------- To Health Professionals: Implementation of March 14, 1995 Do Do Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration -------------------------------------------------------------------------------------------------------------------------------------------------------- To All Establishments Performing Red Blood Cell March 14, 1995 Do Do Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma -------------------------------------------------------------------------------------------------------------------------------------------------------- Reviewer Guidance, Computer Software March 26, 1995 FDA Personnel Do -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45435]] Recommendations for the Deferral of Current and June 8, 1995 FDA Regulated Industry Do Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma -------------------------------------------------------------------------------------------------------------------------------------------------------- Guideline for Quality Assurance in Blood July 11, 1995 Do Do Establishments -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Guidance Document Concerning Use of Pilot July 11, 1995 Do Do Manufacturing Facilities for the Development and Manufacture of Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Disposition of Products Derived from Donors August 8, 1995 Do Do Diagnosed with, or at Known HighRisk for, Creutzfeldt-Jakob Disease -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for Labeling and Use of Units August 8, 1995 Do Do of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained from Donors with Elevated Levels of Alanine Aminotransferase (ALT) -------------------------------------------------------------------------------------------------------------------------------------------------------- Precautionary Measures to Further Reduce the August 8, 1995 Do Do Possible Risk of Transmission of Creutzfeldt- Jakob Disease by Blood and Blood Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for Donor Screening with a August 8, 1995 Do Do Licensed Test for HIV-1 Antigen -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Manufacture and Testing of August 22, 1995 Do Do Therapeutic Products for Human Use Derived from Transgenic Animals -------------------------------------------------------------------------------------------------------------------------------------------------------- Informed Consent for Plasmapheresis/ October 1, 1995 FDA Personnel Do Immunization -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Reviewers' Guide: Changes in Personnel October 1, 1995 FDA Personnel Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Disease Associated Antibody Collection Program October 1, 1995 FDA Personnel Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Content and Format of Investigational New Drug November 1, 1995 FDA Regulated Industry Do Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Concerning Conversion to FDA-Reviewed November 13, 1995 Do Do Software Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Donor Deferral Due to Red Blood Cell Loss December 4, 1995 Do Do During Collection of Source Plasma by Automated Plasmapheresis -------------------------------------------------------------------------------------------------------------------------------------------------------- Interim Definition and Elimination of Lot-by- December 8, 1995 Do Do Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Dear Colleague: Regarding Reverse Transcriptase January 4, 1996 Do Do Activity in Viral Vaccines Produced in Chicken Cells -------------------------------------------------------------------------------------------------------------------------------------------------------- Requesting All Manufacturers Immediately to January 4, 1996 Do Do Revise Warning Section for Package Insert on Thrombin -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45436]] ICH Final Guideline: Quality of February 23, 1996 Do Do Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Dervied Protein Products -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Final Guideline on the Need for Long-Term March 1, 1996 Do Do Rodent Carcinogenicity Study of Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- Additional Recommendations for Donor Screening March 14, 1996 Do Do With a Licensed Test for HIV-1 Antigen -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Guidance Concerning Demonstration of March 26, 1996 Do Do Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline on the Detection of Toxicity to April 5, 1996 Do Do Reproduction for Medicinal Products; Addendum on Toxicity to Male Fertility -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Specific Aspects of Regulatory April 24, 1996 Do Do Genotoxicity Tests for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers of FDA-Regulated Drug/ May 9, 1996 Do Do Biological/Device Products, Bovine Spongiform Encephalopathy (BSE) -------------------------------------------------------------------------------------------------------------------------------------------------------- Additional Recommendations for Testing Whole May 16, 1996 Do Do Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry--The Content and Format May 23, 1996 Do Do for Pediatric Use Supplements -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance on Applications for Products Comprised May 24, 1996 Do Do of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations and Licensure Requirements for May 29, 1996 Do Do Leukocyte-Reduced Blood Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guide to Inspections of Infectious Disease June 1, 1996 FDA Personnel Do Marker Testing Facilities -------------------------------------------------------------------------------------------------------------------------------------------------------- To Manufacturers: Implementation of testing for June 13, 1996 FDA Regulated Industry Do Hepatitis C virus RNA by Manufacturers: Implementation of testing for Hepatitis C virus RNA by polymerase chain reaction (PCR) of intramuscular immune globulin preparations -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Final Guidelines on Stablity Testing of July 10, 1996 Biotechnological/Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline on Structure and Content of July 17, 1996 Do Do Clinical Study Reports -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for the Quarantine and July 19, 1996 Do Do Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I) -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45437]] To Manufacturers: HIV-1 Group O July 31, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry for the Submission of August 15, 1996 Do Do Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA- Derived Product or a Monoclonal Antibody Product for In Vivo Use -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Revised Guidance: Single Dose Acute August 26, 1996 Do Do Toxicity Testing for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Public Health Service Guideline on September 23, 1996 Do Do Infectious Disease Issues in Xenotransplantation; Notice -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guideline on Data Elements for October 1, 1996 Do Do Transmission of Individual Case Reports -------------------------------------------------------------------------------------------------------------------------------------------------------- To All Plasma Derivative Manufacturers and to October 7, 1996 Do Do ABRA: Warning Statement for Plasma Derivative Product Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Advertising and Promotion; Guidance; Notice October 8, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- To Biologic Product Manufacturers: Revised December 3, 1996 Do Do Procedures for Internal Labeling Review Number Assignment -------------------------------------------------------------------------------------------------------------------------------------------------------- Interim Recommendations for Deferral of Donors December 11, 1996 Do Do at Increased Risk for HIV-1 Group O Infection -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC on Plasmid DNA Vaccines for Preventive December 22, 1996 Do Do Infectious Disease Indications -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for the Submission of Chemistry, January 1997 Do Do Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Reviewer Guidance for a Premarket Notification January 13, 1997 FDA Personnel Do Submission for Blood Establishment Computer Software -------------------------------------------------------------------------------------------------------------------------------------------------------- The Food and Drug Administration's Development, February 27, 1997 FDA Regulated Industry Do Issuance, and Use of Guidance Documents -------------------------------------------------------------------------------------------------------------------------------------------------------- Proposed Approach to Regulation of Cellular and February 27, 1997 Do Do Tissue-Based Products -------------------------------------------------------------------------------------------------------------------------------------------------------- PTC in the Manufacture and Testing of February 28, 1997 Do Do Monoclonal Antibody Products for Human Use -------------------------------------------------------------------------------------------------------------------------------------------------------- Tables 1 and 2 from Proposed Approach to March 4, 1997 Do Do Regulation of Cellular and Tissue-Based Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Preclearance of Promotional Labeling; March 5, 1997 Do Do Clarification -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry for the Evaluation of April 1997 Do Do Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45438]] ICH Draft Guideline on Dose Selection for April 2, 1997 Do Do Carcinogenicity Studies for Pharmaceuticals: Addendum on the Limit Dose -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guideline on the Timing of May 2, 1997 Do Do Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guideline on Impurities: Residual May 2, 1997 Do Do Solvents (Correction May 19, 1997) -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline on Stability Testing for New May 9, 1997 Do Do Dosage Forms -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guideline on Statistical Principles May 9, 1997 Do Do for Clinical Trials, Part III -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Good Clinical Practice: Consolidated May 9, 1997 Do Do Guideline, Part II -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline for the Photostability Testing of May 16, 1997 Do Do New Drug Substances and Products, Part II -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline on Impurities in New Drug May 19, 1997 Do Do Products, Part IV -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline on Clinical Safety Data May 19, 1997 Do Do Management: Periodic Safety Update Reports for marketed Drugs, Part VI -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guideline on the Validatioin of Analytical May 19, 1997 Do Do Procedures: Methodology, Part V -------------------------------------------------------------------------------------------------------------------------------------------------------- To Plasma Fractionators--CBER's View on Product May 29, 1997 Do Do Recalls Conducted by the Plasma Fractionation Industry -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guideline on General Considerations May 30, 1997 Do Do for Clinical Trials -------------------------------------------------------------------------------------------------------------------------------------------------------- Guide to Inspections of Source Plasma June 1, 1997 FDA Personnel Do Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs) -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Computerized June 18, 1997 FDA Regulated Industry Do Systems Used in Clinical Trials; Availability -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry--Changes to an Approved July 1997 Do Do Application: Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry--Changes to an Approved July 1997 Do Do Application for Specified Biotechnology and Specified Synthetic Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry--Screening and Testing of July 1997 Do Do Donors of Human Tissue Intended for Transplantation -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry--Donor Screening for August 1997 Do Do Antibodies to HTLV-II -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry on Testing Limits August 1997 Do Do in Stability Protocols for Standardized Grass Pollen Extracts -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45439]] Guidance for Industry--Postmarketing Adverse August 1997 Do Do Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry Efficacy Evaluation September 1997 Do Do of Hemoglobin-and Perfluorocarbon-Based Oxygen Carriers -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry -The Sourcing and September 1997 Do Do Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification Process for Transfusion Related October 7, 1997 Do Do Fatalities and Donation Related Deaths (revised telephone number) -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission Requirements for Requesting October 15, 1997 Do Do Certificates for Exporting Products to Foreign Countries -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Preclinical Safety Evaluation November 18, 1997 Do Do of Biotechnology-Derived Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Genotoxicity: A Standard November 21, 1997 Do Do Battery for Genotoxicity Testing for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Nonclinical Safety Studies for November 25 1997 Do Do the Conduct of Human Clinical Trials for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guidance on Specifications: Test November 25, 1997 Do Do Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for FDA and Industry: Direct Final November 21, 1997 FDA Personnel and Regulated Do Rule Procedures Industry -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Promoting Medical December 1997 FDA Regulated Industry Do Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Industry-Supported December 3, 1997 Do Do Scientific and Educational Activities -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Dose Selection for December 4, 1997 Do Do Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes -------------------------------------------------------------------------------------------------------------------------------------------------------- To Biologic Product Manufacturers--Withdrawal December 11, 1997 Do Do of Human Blood-Derived Materials Because Donors Diagnosed With, or At Increased Risk For, CJD -------------------------------------------------------------------------------------------------------------------------------------------------------- To Allergenic Extract Manufacturers-- December 23, 1997 Do Do Standardized Grass Pollen Extracts -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Data Elements for Transmission January 15, 1998 of Individual Case Safety Reports -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45440]] Guidance for Industry: Year 2000 Date Change January 1998 Do Do for Computer Systems and Software Applications Used in the Manufacture of Blood Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Container and January 1998 Do Do Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Testing for Carncinogenicity of February 28, 1998 Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Manufacturing, March 1998 Do Do Processing or Holding Active Pharmaceutical Ingredients -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Guidance for Human March 1998 Do Do Somatic Cell Therapy and Gene Therapy -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Instructions for May 1998 Do Do Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Pilot Program for May 1998 Do Do Electronic Investigational New Drug (eIND) Applications for Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Submitting and Reviewing May 1998 Do Do Complete Responses to Clinical Holds -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Classifying May 1998 Do Do Resubmissions in Response to Action Letters -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Pharmacokinetics in May 1998 Do Do Patients with Impaired Renal Function--Study Design, Data Analysis and Impact on Dosing and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Standards for the Prompt May 1998 Do Do Review of Efficacy Supplements, Including Priority Efficacy Supplements -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Providing Clinical May 1998 Do Do Evidence of Effectiveness for Human Drugs and Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Stability Testing June 1998 Do Do of Drug Substances and Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Qualifying for Pediatric June 1998 Do Do Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Errors and Accidents June 1998 Do Do Regarding Saline Dilution of Samples Used for Viral Marker Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Draft Guidance on Specifications: Test June 9, 1998 Do Do Procedures and Acceptance Criteria for Biotechnological/Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Ethnic Factors in the June 10, 1998 Do Do Acceptability of Foreign Clinical Data -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45441]] Draft Guidance for Industry: Exports and June 12, 1998 Do Do Imports Under the FDA Export Reform and Enhancement Act of 1996 -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Implementation of July 1998 Do Do Section 126 of the Food and Drug Administration Modernization Act of 1997-- Elimination of Certain Labeling Requirements -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Environmental Assessment July 1998 Do Do of Human Drug and Biologics Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Recommendations July 1998 Do Do for Collecting Red Blood Cells by Automated Apheresis Methods -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Current Good September 1998 Do Do Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Submitting September 1998 Do Do Debarment Certification Statements -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: How to Complete the September 1998 Do Do Vaccine Adverse Reporting System Form (VAERS- 1) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Fast Track Drug September 1998 Do Do Development Programs--Designation, Development, and Application Review -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Statistical Principles for September 16, 1998 Do Do Clinical Trials -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Quality of Biotechnological/ September 21, 1998 Do Do Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Viral Safety Evaluation of September 24, 1998 Do Do Biotechnology Products Derived From Cell Lines of Human or Animal Origin -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Developing Medical October 1998 Do Do Imaging Drugs and Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: on Advisory Committees: October 1998 Do Do Implementing Section 120 of the Food and Drug Administration Act of 1997 -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Document: United States Industry December 1997 (Released Do Do Consensus Standard for the Uniform Labeling of November 1998) Blood and Blood Components Using ISBT 128 -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: General November 1998 Do Do Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- To Viral Vaccine IND Sponsors--Use of PCR-based December 18, 1998 Do Do Reverse Transcriptase Assay -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45442]] Guidance for Industry: FDA Approval of New December 1998 Do Do Cancer Treatment Uses for Marketed Drug and Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Content and Format December 1998 Do Do of Geriatric Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Product Name January 1999 Do Do Placement, Size and Prominence in Advertising and Promotional Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Content and Format of January 1999 Do Do Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance on Amended Procedures for Advisory January 1999 Do Do Panel Meetings -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Providing Regulatory January 1999 Do Do Submissions in Electronic Format--General Considerations -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Population February 1999 Do Do Pharmacokinetics -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: For the Submission of February 1999 Do Do Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: For the Submission of February 1999 Do Do Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: INDs for Phase 2 February 1999 Do Do and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry Manufacturing and Controls Content and Format -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Accelerated March 1999 Do Do Approval Products--Submission of Promotional Materials -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Content and Format of March 1999 Do Do Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Public Health Issues April 1999 Do Do Posed by the Use of Nonhuman Primate Xenografts in Humans -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry On the Content and Format April 1999 Do Do of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45443]] Guidance for Industry For the Submission of May 1999 Do Do Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use'' -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry For Platelet Testing and May 1999 Do Do Evaluation of Platelet Substitute Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Efficacy Studies to May 1999 Do Do Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Monoclonal May 1999 Do Do Antibodies Used as Reagents in Drug Manufacturing -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Container Closure May 1999 Do Do Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Establishing June 1999 Do Do Pregnancy Registries -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Reviewer Guidance: Evaluation of Human June 1999 FDA Personnel Do Pregnancy Outcome Data -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Current Good June 1999 FDA Regulated Industry Do Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of donor Test Results for Antibody to HCV (Anti-HCV) -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on the Duration of Chronic June 25, 1999 Do Do Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Clinical July 1999 Do Do Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Interpreting July 1999 Do Do Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Cooperative August 1999 Do Do Manufacturing Arrangements for Licensed Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Consumer-Directed August 1999 Do Do Broadcast Advertisements -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Information August 1999 Do Do Request and Discipline Review Letters Under the Prescription Drug User Fee Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Possible Dioxin/PCB August 1999 Do Do Contamination of Drug and Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45444]] Guidance for Industry: Submission of August 1999 Do Do Abbreviated Reports and Synopses in Support of Marketing Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- ICH Guidance on Specifications: Test Procedures August 18, 1999 Do Do and Acceptance Criteria for Biotechnological/ Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Revised September 1999 Do Do Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Qualifying for Pediatric September 1999 Do Do Exclusivity Under Section 505A of the Federal Food, Drug and Cosmetic Act -------------------------------------------------------------------------------------------------------------------------------------------------------- International Conference on Harmonisation Draft September 24, 1999 Do Do Guidance; Choice of Control Group in Clinical Trials -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Supplemental November 1999 Do Do Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Providing Regulatory November 1999 Do Do Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format--Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]--Revised -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Revised Precautionary November 1999 Do Do Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: In Vivo Drug Metabolism/ November 1999 Do Do Drug Interaction Studies--Study Design, Data Analysis and Recommendations for Dosing and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Application of November 1999 Do Do Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Pharmacokinetics November 1999 Do Do in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- International Conference on Harmonisation of November 8, 1999 Do Do Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical Document -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: In the Manufacture and December 1999 Do Do Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45445]] Draft Guidance for Industry: Precautionary December 1999 Do Do Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Special Protocol December 1999 Do Do Assessment -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Changes to an January 2000 Do Do Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Reviewers: Potency Limits February 2000 FDA Personnel Do for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: IND Meetings for February 2000 FDA Regulated Industry Do Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Formal Meetings With February 2000 Do Do Sponsors and Applicants for PDUFA Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Formal Dispute February 2000 Do Do Resolution: Appeals Above the Division Level -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Industry: Gamma Irradiation of February 2000 Do Do Blood and Blood Components: A Pilot Program for Licensing -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry: Information March 2000 Do Do Program on Clinical Trials for Serious or Life- Threatening Diseases: Establishment of a Data Bank -------------------------------------------------------------------------------------------------------------------------------------------------------- International Conference on Harmonisation; E11: April 12, 2000 Do Do Clinical Investigation of Medicinal Products in the Pediatric Population -------------------------------------------------------------------------------------------------------------------------------------------------------- International Conference on Harmonisation; April 21, 2000 Do Do Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products -------------------------------------------------------------------------------------------------------------------------------------------------------- III. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER) -------------------------------------------------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of the Document Name of Document Date of Issuance Grouped by Intended User (Name and Address, Phone, FAX, E-mail or or Regulatory Activity Internet) -------------------------------------------------------------------------------------------------------------------------------------------------------- Accelerated Approval Products--Submission of March 26, 1999 Advertising Draft http://www.fda.gov/cder/guidance/index.htm Promotional Materials -------------------------------------------------------------------------------------------------------------------------------------------------------- Product Name, Placement, Size, and Prominence in March 12, 1999 Do Do Advertising and Promotional Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Promoting Medical Products in a Changing January 5, 1998 Do Do Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) -------------------------------------------------------------------------------------------------------------------------------------------------------- Aerosol Steroid Product Safety Information in January 12, 1998 Advertising Do Prescription Drug Advertising and Promotional Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45446]] Consumer-Directed Broadcast Advertisements August 9, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Antifungal (topical) February 24, 1990 Biopharmaceutic Draft Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Antifungal (vaginal) February 24, 1990 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Average, Population, and Individual Approaches to August 27, 1999 Do Do Establishing Bioequivalence -------------------------------------------------------------------------------------------------------------------------------------------------------- Bioanalytical Methods Validations for Human January 5, 1999 Do Do Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- Bioavailability and Bioequivalence Studies for June 2, 1999 Do Do Nasal Aerosols and Nasal Sprays for Local Action -------------------------------------------------------------------------------------------------------------------------------------------------------- Bioavailability and Bioequivalence Studies for August 27, 1999 Do Do Orally Administered Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Conjugated Estrogens, USP: LC-MS Method for Both March 9, 2000 Do Do Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence -------------------------------------------------------------------------------------------------------------------------------------------------------- Food-Effect Bioavailability and Bioequivalence December 20, 1997 Do Do Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- Topical Dermatological Drug Product NDA's and June 18, 1998 Do Do ANDA's--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- Waiver of In Vivo Bioavailability and February 17, 1999 Do Do Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients -------------------------------------------------------------------------------------------------------------------------------------------------------- Buspirone Hydrochloride Tablets In Vivo May 15, 1998 Biopharmaceutic Do Bioequivalence and In Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Cholestyramine Powder In Vitro Bioequivalence July 15, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Cimetidine Tablets In Vivo Bioequivalence and In June 12, 1992 Do Do Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Clozapine (Tablets) In Vivo Bioequivalence and In November 15, 1996 Do Do Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Corticosteroids, Dermatologic (topical) In Vivo June 2, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Diclofenac Sodium (tablets) In Vivo Bioequivalence October 6, 1994 Do Do and In Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Dissolution Testing of Immediate Release Solid August 25, 1997 Do Do Oral Dosage Forms -------------------------------------------------------------------------------------------------------------------------------------------------------- Extended Release Oral Dosage Forms: Development, September 26, 1997 Do Do Evaluation, and Application of In Vitro/In Vivo Correlations -------------------------------------------------------------------------------------------------------------------------------------------------------- Glipizide (Tablets) In Vivo Bioequivalence and In April 23, 1993 Do Do Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Glyburide Tablets In Vivo Bioequivalence and In April 23, 1993 Do Do Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Metaproterenol Sulfate and Albuterol Metered Dose June 27, 1989 Do Do Inhalers In Vitro -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45447]] Oral Extended (Controlled) Release Dosage Forms In September 9, 1993 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Phenytoin/Phenytion Sodium (capsules, tablets, March 4, 1994 Do Do suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Potassium Chloride (slow-release tablets and June 6, 1994 Do Do capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- Statistical Procedure for Bioequivalence Studies July 1, 1992 Do Do Using a Standard Two-Treatment Crossover Design -------------------------------------------------------------------------------------------------------------------------------------------------------- BACPAC I: Intermediates in Drug Substance November 30, 1998 Chemistry Draft Do Synthesis (Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation) -------------------------------------------------------------------------------------------------------------------------------------------------------- IND Meetings for Human Drugs and Biologics; February 4, 2000 Do Do Chemistry, Manufacturing, and Controls Information -------------------------------------------------------------------------------------------------------------------------------------------------------- IND's for Phase 2 and 3 Studies of Drugs, April 20, 1999 Do Do Including Specified Therapeutic Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls Content and Format -------------------------------------------------------------------------------------------------------------------------------------------------------- Metered Dose Inhalers (MDI) and Dry Powder November 19, 1998 Do Do Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation -------------------------------------------------------------------------------------------------------------------------------------------------------- Monoclonal Antibodies Used as Reagents in Drug June 24, 1999 Do Do Manufacturing -------------------------------------------------------------------------------------------------------------------------------------------------------- Nasal Spray and Inhalation Solution, Suspension, June 2, 1999 Do Do and Spray Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Stability Testing of Drug Substances and Drug June 8, 1998 Do Do Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Supporting Chemistry Documentation in November 1, 1991 Do Do Radiopharmaceutical Drug Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- SUPAC-SS: Nonsterile Semisolid Dosage Forms January 5, 1999 Do Do Manufacturing Equipment Addendum -------------------------------------------------------------------------------------------------------------------------------------------------------- Tracking of NDA and ANDA Reformulations for Solid, Do Do Oral, Immediate Release Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Changes to an Approved Application for Specified July 24, 1997 Chemistry Do Biotechnology and Specified Synthetic Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Changes to an Approved NDA or ANDA November 23, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Container Closure Systems for Packaging Human July 7, 1999 Do Do Drugs and Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Drug Master Files September 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Drug Master Files for Bulk Antibiotic Drug November 29, 1999 Do Do Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- Environmental Assessment of Human Drugs and July 27, 1998 Do Do Biologics Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45448]] FDA's Policy Statement for the Development of New May 1, 1992 Do Do Stereoisomeric Drugs -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content for the CMC Section of an September 1, 1994 Do Do Annual Report -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content of the Chemistry, Manufacturing February 1, 1987 Do Do and Controls Section of an Application -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content of the Microbiology Section of February 1, 1987 Do Do an Application -------------------------------------------------------------------------------------------------------------------------------------------------------- NDAs: Impurities in Drug Substances February 25, 2000 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- PAC-ALTS: Postapproval Changes--Analytical Testing April 28, 1998 Do Do Laboratory Sites -------------------------------------------------------------------------------------------------------------------------------------------------------- Reviewer Guidance: Validation of Chromatographic November 1, 1994 Do Do Methods -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of Chemistry, Manufacturing and November 1, 1994 Do Do Controls Information for Synthetic Peptide Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of Documentation for Sterilization November 1, 1994 Do Do Process Validation Applications for Human and Veterinary Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Documentation for the Manufacturing of February 1, 1987 Do Do and Controls for Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Documentation for the Stability of February 1, 1987 Do Do Human Drugs and Biologics -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Samples and Analytical Data for Methods February 1, 1987 Do Do Validation -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Supporting Documentation in Drug February 1, 1987 Do Do Applications for the Manufacture of Drug Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Supporting Documentation in Drug February 1, 1987 Do Do Applications for the Manufacture of Drug Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- SUPAC IR- Immediate-Release Solid Oral Dosage November 30, 1995 Do Do Forms: Scale-Up and Post- Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing -------------------------------------------------------------------------------------------------------------------------------------------------------- SUPAC IR/MR: Immediate Release and Modified February 26, 1999 Do Do Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum -------------------------------------------------------------------------------------------------------------------------------------------------------- SUPAC-IR Questions and Answers February 18, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- SUPAC-MR: Modified Release Solid Oral Dosage October 6, 1997 Do Do Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation -------------------------------------------------------------------------------------------------------------------------------------------------------- SUPAC-SS--Nonsterile Semisolid Dosage Forms; Scale- June 13, 1997 Do Do Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45449]] Acute Bacterial Exacerbation of Chronic July 22, 1998 Clinical Antimicrobial Do Bronchitis; Developing Antimicrobial Drugs for Draft Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Acute Bacterial Meningitis; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Acute Bacterial Sinusitis; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Acute Otitis Media; Developing Antimicrobial Drugs July 22, 1998 Do Do for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Bacterial Vaginosis; Developing Antimicrobial July 22, 1998 Do Do Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Catheter-Related Bloodstream Infections-- October 18, 1999 Do Do Developing Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Considerations for Accelerated and September 1, 1999 Do Do Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements -------------------------------------------------------------------------------------------------------------------------------------------------------- Community Acquired Pneumonia; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Complicated Urinary Tract Infections and July 22, 1998 Do Do Pylonephritis; Developing Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Developing Antimicrobial Drugs-General July 22, 1998 Do Do Considerations for Clinical Trials -------------------------------------------------------------------------------------------------------------------------------------------------------- Empiric Therapy of Febrile Neutropenia; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Evaluating Clinical Studies of Antimicrobials in February 17, 1997 Do Do the Division of Anti-Infective Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Lyme Disease; Developing Antimicrobial Drugs for July 22, 1998 Do Do Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Nosocomial Pneumonia; Developing Antimicrobial July 22, 1998 Do Do Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Secondary Bacterial Infections of Acute July 22, 1998 Do Do Bronchitis; Developing Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Streptococcal Pharyngitis and Tonsillitis; July 22, 1998 Do Do Developing Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Uncomplicated and Complicated Skin and Skin July 22, 1998 Do Do Structure Infections; Developing Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Uncomplicated Gonorrhea--Cervical, Urethral, July 22, 1998 Do Do Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Uncomplicated Urinary Tract Infections; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Vuvlovaginal Candidiasis; Developing Antimicrobial July 22, 1998 Do Do Drugs for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Development and Labeling of Anti- October 26, 1992 Clinical Antimicrobial Do Infective Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Anti-Infective Drugs September 1, 1977 Do Do (Systemic) -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45450]] Preclinical Development of Antiviral Drugs November 1, 1990 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Abuse Liability Assessment July 1, 1990 Clinical Medical Draft Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Development Programs for Drugs, Devices, July 15, 1999 Do Do and Biological Products Intended for the Treatment of Osteoarthritis (OA) -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Anti-Anginal Drugs January 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Anti-Arrhythmic Drugs July 1, 1985 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Antihypertensive Drugs May 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Drugs for the Treatment of December 1, 1987 Do Do Congestive Heart Failure -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Drugs for Ulcerative Do Do Colitis (3rd draft) -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Lipid-Altering Agents in September 1, 1990 Do Do Adults and Children -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Motility-Modifying Drugs Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Weight-Control Drugs September 24, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Conducting a Clinical Safety Review of a New November 22, 1996 Do Do Product Application and Preparing a Report on the Review -------------------------------------------------------------------------------------------------------------------------------------------------------- Conducting a Clinical Safety Review of a New October 13, 1998 Do Do Product Application and Preparing a Report on the Review -------------------------------------------------------------------------------------------------------------------------------------------------------- Development and Evaluation of Drugs for the February 12, 1992 Do Do Treatment of Psychoactive Substance Use Disorders -------------------------------------------------------------------------------------------------------------------------------------------------------- Development of Parathyroid Hormone for the June 14, 2000 Do Do Prevention and Treatment of Osteoporosis -------------------------------------------------------------------------------------------------------------------------------------------------------- Establishing Pregnancy Registries June 4, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Evaluation of Human Pregnancy Outcome Data June 4, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Female Sexual Dysfunction: Clinical Development of May 19, 2000 Do Do Drug Products for Treatment -------------------------------------------------------------------------------------------------------------------------------------------------------- In Vivo Pharmacokinetics and Bioavailability June 10, 1999 Do Do Studies and In Vitro Dissolution Testing for Levothyroxine Sodium Tablets -------------------------------------------------------------------------------------------------------------------------------------------------------- Institutional Review Boards, Clinical March 30, 2000 Do Do Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research -------------------------------------------------------------------------------------------------------------------------------------------------------- Levothyroxine Sodium August 18, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- OTC Treatment of Herpes Labialis with Antiviral March 8, 2000 Do Do Agents -------------------------------------------------------------------------------------------------------------------------------------------------------- Preclinical and Clinical Evaluation of Agents Used April 1, 1994 Do Do in the Prevention or Treatment of Postmenopausal Osteoporosis -------------------------------------------------------------------------------------------------------------------------------------------------------- Preparation of IND Applications for New Drugs September 1, 1991 Do Do Intended for the Treatment of HIV-Infected Individuals -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45451]] System Inflammatory Response Syndrome (SIRS) 1st Do Do Draft -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Development Programs for Drugs, Devices, February 17, 1999 Clinical Medical Do and Biological Products for the Treatment of Rheumatoid Arthritis (RA) -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Development Programs for MDI and DPI Drug September 19, 1994 Do Do Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Analgesic Drugs December 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Antacid Drugs April 1, 1978 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Anti-Inflammatory and April 1, 1988 Do Do Antirheumatic Drugs (adults and children) -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Antianxiety Drugs September 1, 1977 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Antidepressant Drugs September 1, 1977 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Antidiarrheal Drugs September 1, 1977 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Antiepileptic Drugs (adults January 1, 1981 Do Do and children) -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Combination Estrogen/ March 20, 1995 Do Do Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Gastric Secretory September 1, 1977 Do Do Depressant (GSD) Drugs -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of General Anesthetics May 1, 1982 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Laxative Drugs April 1, 1978 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Local Anesthetics May 1, 1982 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Psychoactive Drugs in July 1, 1979 Do Do Infants and Children -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Evaluation of Radiopharmaceutical Drugs October 1, 1981 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Content and Format for Pediatric Use Supplements May 24, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Content and Format of Investigational New Drug November 20, 1995 Do Do Applications (IND's) for Phase Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Development of Vaginal Contraceptive Drugs (NDA) April 19, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Approval of New Cancer Treatment Uses for February 2, 1999 Do Do Marketed Drug and Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Requirements for Approval of Drugs to Treat January 21, 1991 Do Do Non-Small Cell Lung Cancer -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Requirements for Approval of Drugs to Treat June 20, 1989 Do Do Superficial Bladder Cancer -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content of the Clinical and Statistical July 1, 1988 Do Do Sections of an Application -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content of the Summary for New Drug and February 1, 1987 Do Do Antibiotic Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45452]] Formatting, Assembling and Submitting New Drug and February 1, 1987 Do Do Antibiotic Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- General Considerations for the Clinical Evaluation February 1, 1978 Do Do of Drugs -------------------------------------------------------------------------------------------------------------------------------------------------------- General Considerations for the Clinical September 1, 1977 Do Do Evaluation of Drugs in Infants and Children -------------------------------------------------------------------------------------------------------------------------------------------------------- Oncologic Drugs Advisory Committee Discussion on April 13, 1988 Do Do FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer -------------------------------------------------------------------------------------------------------------------------------------------------------- Oncologic Drugs Advisory Committee Discussion on April 19, 1988 Do Do FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer -------------------------------------------------------------------------------------------------------------------------------------------------------- OTC Treatment of Hypercholesterolemia October 27, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Postmarketing Adverse Experience Reporting for August 27, 1997 Do Do Human Drugs and Licensed Biological Products; Clarification of What to Report -------------------------------------------------------------------------------------------------------------------------------------------------------- Postmarketing Reporting of Adverse Drug March 1, 1992 Do Do Experiences -------------------------------------------------------------------------------------------------------------------------------------------------------- Preclinical Development of Immunomodulatory Drugs September 4, 1992 Do Do for the Treatment of HIV Infection and Associated Disorders -------------------------------------------------------------------------------------------------------------------------------------------------------- Preparation of Investigational New Drug Products November 1, 1992 Do Do (Human and Animal) -------------------------------------------------------------------------------------------------------------------------------------------------------- Providing Clinical Evidence of Effectiveness for May 15, 1998 Do Do Human Drug and Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Study and Evaluation of Gender Differences in the July 22, 1993 Do Do Clinical Evaluation of Drugs -------------------------------------------------------------------------------------------------------------------------------------------------------- Study of Drugs Likely to be Used in the Elderly November 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Submission of Abbreviated Reports and Synopses in September 13, 1999 Do Do Support of Marketing Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- General Considerations for Pediatric November 30, 1998 Clinical Pharmacology Do Pharmacokinetic Studies for Drugs and Biological Draft Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Drug Metabolism/Drug Interaction Studies in the April 7, 1997 Clinical Pharmacology Do Drug Development Process: Studies In Vitro -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content of the Human Pharmacokinetics February 1, 1987 Do Do and Bioavailability Section of an Application -------------------------------------------------------------------------------------------------------------------------------------------------------- In Vivo Metabolism/Drug Interaction Studies--Study November 24, 1999 Do Do Design, Data Analysis, and Recommendations for Dosing and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Pharmacokinetics and Pharmacodynamics in Patients May 15, 1998 Do Do with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Pharmacokinetics in Patients With Impaired Hepatic December 7, 1999 Do Do Function: Study Design, Data Analysis, and Impact on Dosing and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Population Pharmacokinetics February 10, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45453]] Investigating Out of Specification (OOS) Test November 30, 1998 Compliance Draft Do Results for Pharmaceutical Production -------------------------------------------------------------------------------------------------------------------------------------------------------- Manufacture, Processing or Holding of Active April 17, 1998 Do Do Pharmaceutical Ingredients -------------------------------------------------------------------------------------------------------------------------------------------------------- Repackaging of Solid Oral Dosage Form Drug February 1, 1992 Do Do Products -------------------------------------------------------------------------------------------------------------------------------------------------------- A Review of FDA's Implementation of the Drug Compliance Do Export Amendments of 1986 -------------------------------------------------------------------------------------------------------------------------------------------------------- Compressed Medical Gases February 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Computerized Systems Used in Clinical Trials May 10, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Expiration Dating and Stability Testing of Solid June 27, 1997 Do Do Oral Dosage Form Drugs Containing Iron -------------------------------------------------------------------------------------------------------------------------------------------------------- General Principles of Process Validation May 1, 1987 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Good Laboratory Practice Regulations Questions and Do Do Answers -------------------------------------------------------------------------------------------------------------------------------------------------------- Monitoring of Clinical Investigations January 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Nuclear Pharmacy Guideline Criteria for May 1, 1984 Do Do Determining When to Register as a Drug Establishment -------------------------------------------------------------------------------------------------------------------------------------------------------- Possible Dioxin/PCB Contamination of Drug and August 23, 1999 Do Do Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Sterile Drug Products Produced by Aseptic May 1, 1987 Do Do Processing -------------------------------------------------------------------------------------------------------------------------------------------------------- Validation of Limulus Amebocyte Lysate Test as an December 1, 1987 Do Do End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulatory Submissions in Electronic Format; January 28, 1999 Electronic Submissions Do General Considerations -------------------------------------------------------------------------------------------------------------------------------------------------------- Regulatory Submissions in Electronic Format; New January 28, 1999 Do Do Drug Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- ANDA's: Blend Uniformity Analysis August 26, 1999 Generic Drug Draft Do -------------------------------------------------------------------------------------------------------------------------------------------------------- ANDA's: Impurities in Drug Products January 5, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Abbreviated New Drug Application (ANDA)--Positron April 18, 1997 Do Do Emission Tomography (PET) Drug Products--With specific information for ANDA's for Fludeoxyglucose F18 Injection -------------------------------------------------------------------------------------------------------------------------------------------------------- ANDA's: Impurities in Drug Substances December 3, 1999 Generic Drug Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter announcing that the OGD will now accept the August 18, 1995 Do Do ICH long-term storage conditions as well as the stability studies conducted in the past -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter describing efforts by the CDER & the ORA to October 14, 1994 Do Do clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45454]] Letter on incomplete Abbreviated Applications, April 8, 1994 Do Do Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter on the provision of new information July 1, 1992 Do Do pertaining to new bioequivalence guidelines and refuse-to-file letters -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter on the provision of new procedures and March 15, 1989 Do Do policies affecting the generic drug review process -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter on the request for cooperation of regulated November 8, 1991 Do Do industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter on the response to December 20, 1984 letter March 26, 1985 Do Do from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter to all ANDA and AADA applicants about the January 15, 1993 Do Do Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse to file incomplete submissions as required by the new law -------------------------------------------------------------------------------------------------------------------------------------------------------- Letter to regulated industry notifying interested August 4, 1993 Do Do parties about important detailed information regarding labeling, scale-up, packaging, minor/ major amendment criteria, and bioequivalence requirements -------------------------------------------------------------------------------------------------------------------------------------------------------- Major, Minor, Facsimile, and Telephone Amendments May 1, 2000 Do Do to Original Abbreviated New Drug Applications (Revised) -------------------------------------------------------------------------------------------------------------------------------------------------------- Organization of an ANDA March 2, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Revising ANDA Labeling Following Revision of the April 25, 2000 Do Do RLD Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Skin Irritation and Sensitization Testing of February 3, 2000 Do Do Generic Transdermal Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Variations in Drug Products that May Be Included January 27, 1999 Do Do in a Single ANDA -------------------------------------------------------------------------------------------------------------------------------------------------------- E10--Choice of Control Group in Clinical Trials September 24, 1999 ICH Draft--Efficacy Do -------------------------------------------------------------------------------------------------------------------------------------------------------- E11 Clinical Investigation of Medicinal Products April 12, 2000 Do Do in the Pediatric Population -------------------------------------------------------------------------------------------------------------------------------------------------------- M4 Common Technical Document: Request for comments February 11, 2000 ICH Draft--Joint Safety/ Do on Initial Components Efficacy -------------------------------------------------------------------------------------------------------------------------------------------------------- Q1A(R) Stability Testing of New Drug Substances April 21, 2000 ICH Draft--Quality Do and Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Q6A Specifications: Test Procedures and Acceptance November 25, 1997 Do Do Criteria for New Drug Substances and New Drug Products: Chemical Substances -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45455]] E1A The Extent of Population Exposure to Assess March 1, 1995 ICH--Efficacy Do Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions -------------------------------------------------------------------------------------------------------------------------------------------------------- E2A Clinical Safety Data Management: Definitions March 1, 1995 Do Do and Standards for Expedited Reporting -------------------------------------------------------------------------------------------------------------------------------------------------------- E2B Data Elements for Transmission of Individual January 15, 1998 Do Do Case Safety Reports -------------------------------------------------------------------------------------------------------------------------------------------------------- E2C Clinical Safety Data Management: Periodic May 19, 1997 Do Do Safety Update Reports for Marketed Drugs -------------------------------------------------------------------------------------------------------------------------------------------------------- E3 Structure and Content of Clinical Study Reports July 17, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- E4 Dose-Response Information to Support Drug November 9, 1994 Do Do Registration -------------------------------------------------------------------------------------------------------------------------------------------------------- E5 Ethnic Factors in the Acceptability of Foreign June 10, 1998 Do Do Clinical Data -------------------------------------------------------------------------------------------------------------------------------------------------------- E6 Good Clinical Practice: Consolidated Guideline May 9, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- E7 Studies in Support of Special Populations: August 2, 1994 Do Do Geriatrics -------------------------------------------------------------------------------------------------------------------------------------------------------- E8 General Considerations for Clinical Trials December 24, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- E9 Statistical Principles for Clinical Trials September 16, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- M3 Nonclinical Safety Studies for the Conduct of November 25, 1997 ICH--Joint Safety/ Do Human Clinical Trials for Pharmaceuticals Efficacy -------------------------------------------------------------------------------------------------------------------------------------------------------- Q1A Stability Testing of New Drug Substances and September 22, 1994 ICH--Quality Do Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Q1B Photostability Testing of New Drug Substances May 16, 1997 Do Do and Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Q1C Stability Testing for New Dosage Forms May 9, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Q2A Text on Validation of Analytical Procedures May 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Q2B Validation of Analytical Procedures: May 19, 1997 Do Do Methodology -------------------------------------------------------------------------------------------------------------------------------------------------------- Q3A Impurities in New Drug Substances January 4, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Q3B Impurities in New Drug Products May 19, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Q3C Impurities: Residual Solvents December 24, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Q5A Viral Safety Evaluation of Biotechnology September 24, 1998 Do Do Products Derived From Cell Lines of Human or Animal Origin -------------------------------------------------------------------------------------------------------------------------------------------------------- Q5B Quality of Biotechnology Products: Analysis of February 23, 1996 Do Do the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Q5C Quality of Biotechnological Products: July 10, 1996 Do Do Stability Testing of Biotechnology/Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45456]] Q5D Quality of Biotechnological/Biological September 21, 1998 Do Do Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Q6B--Test Procedures and Acceptance Criteria for August 18, 1999 Do Do Biotechnological/Biological Products -------------------------------------------------------------------------------------------------------------------------------------------------------- S1A The Need for Long-Term Rodent Carcinogenicity March 1, 1996 ICH--Safety Do Studies of Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- S1B Testing for Carcinogenicity in Pharmaceuticals February 23, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- S1C Dose Selection for Carcinogenicity Studies of March 1, 1995 Do Do Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- S1C(R) Dose Selection for Carcinogenicity Studies December 4, 1997 Do DO of Pharmaceuticals: Addendum on a Limit Dose and Related Notes -------------------------------------------------------------------------------------------------------------------------------------------------------- S2A Specific Aspects of Regulatory Genotoxicity December 4, 1997 Do Do Tests for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- S2B Genotoxicity: Standard Battery Testing November 21, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- S3A Toxicokinetics: The Assessment of systemic March 1, 1995 Do Do Exposure in Toxicity Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- S3B Pharmacokinetics: Guidance for Repeated Dose March 1, 1995 Do Do Tissue Distribution Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- S4A Duration of Chronic Toxicity Testing in June 25, 1999 Do Do Animals (Rodent and Nonrodent Toxicity Testing) -------------------------------------------------------------------------------------------------------------------------------------------------------- S5A Detection of Toxicity to Reproduction for September 22, 1994 Do Do Medicinal Products -------------------------------------------------------------------------------------------------------------------------------------------------------- S5B Detection of Toxicity to Reproduction for April 5, 1996 Do Do Medicinal Products: Addendum on Toxicity to Male Fertility -------------------------------------------------------------------------------------------------------------------------------------------------------- S6 Preclinical Safety Evaluation of Biotechnology- November 18, 1997 Do Do Derived Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- A Revision in Sample Collection Under the July 15, 1996 Industry Letters o Compliance Program Pertaining to Pre-Approval Inspections -------------------------------------------------------------------------------------------------------------------------------------------------------- Certification Requirements for Debarred July 27, 1992 Do Do Individuals in Drug Applications -------------------------------------------------------------------------------------------------------------------------------------------------------- Continuation of a series of letters communicating June 1, 1990 Do Do interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program -------------------------------------------------------------------------------------------------------------------------------------------------------- Fifth of a series of letters providing informal April 10, 1987 Do Do notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required -------------------------------------------------------------------------------------------------------------------------------------------------------- Fourth of a series of letters providing informal October 31, 1986 Do Do notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45457]] Implementation of the Drug Price Competition and October 11, 1984 Do Do Patent Term Restoration Act. Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Instructions for Filing Supplements Under the April 11, 1996 Do Do Provisions of SUPAC-IR -------------------------------------------------------------------------------------------------------------------------------------------------------- Seventh of a series of letters about the Act July 29, 1988 Do Do providing guidance on the ``180-day exclusivity'' provision of section 505(j)(4)(B)(iv) of the FD&C -------------------------------------------------------------------------------------------------------------------------------------------------------- Sixth of a series of informal notice letters about April 22, 1988 Do Do the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Streamlining Initiatives December 24, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Supplement to 10/11/84 letter about policies, November 16, 1984 Do Do procedures and implementation of the Act (Q & A format) -------------------------------------------------------------------------------------------------------------------------------------------------------- Third of a series of letters regarding the May 1, 1985 Do Do implementation of the Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Content and Format for Geriatric Labeling January 21, 1999 Labeling Draft Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Non-Contraceptive Estrogen Drug Products-- January 8, 1999 Do Do Physician and Patient Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Noncontraceptive Estrogen Class Labeling September 27, 1999 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- OTC Topical Drug Products for the Treatment of July 16, 1998 Do Do Vaginal Yeast Infections (Vulvovaginal Candidiasis) -------------------------------------------------------------------------------------------------------------------------------------------------------- Therapeutic Equivalence Code Placement on January 28, 1999 Do Do Prescription Drug Labels and Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Acetaminophen and Codeine Phosphate Oral Solution/ December 1, 1993 Labeling Do Suspension -------------------------------------------------------------------------------------------------------------------------------------------------------- Acetaminophen and Codeine Phosphate Tablets/ December 1, 1993 Do Do Capsules -------------------------------------------------------------------------------------------------------------------------------------------------------- Acetaminophen, Aspirin and Codeine Phosphate December 1, 1993 Do Do Tablets/Capsules -------------------------------------------------------------------------------------------------------------------------------------------------------- Alprazolam Tablets USP August 1, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Amiloride Hydrochloride and Hydrochlorothiazide September 1, 1997 Do Do Tablets USP -------------------------------------------------------------------------------------------------------------------------------------------------------- Amlodipine Besylate Tablets September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Astemizole Tablets September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Atenolol Tablets USP August 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Barbiturate, Single Entity-Class Labeling March 1, 1981 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Butalbital, Acetaminophen and Caffeine Capsules/ September 1, 1997 Do Do Tablets USP -------------------------------------------------------------------------------------------------------------------------------------------------------- Butalbital, Acetaminophen, Caffeine and Hydocodone September 21, 1997 Do Do Bitartrate Tablets -------------------------------------------------------------------------------------------------------------------------------------------------------- Butorphanol Tartrate Injection USP October 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45458]] Captopril and Hydrochlorothiazide Tablets USP April 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Captopril Tablets February 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Carbidopa and Levodopa Tablets USP February 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Chlordiazepoxide Hydrochloride Capsules January 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Cimetidine Hydrochloride Injection September 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Cimetidine Tablets September 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Cisapride Oral Suspension September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Cisapride Tablets September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clindamycin Phosphate Injection USP September 1, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Clorazepate Dipotassium Capsules/Tablets March 1, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Combination Oral Contraceptives--Physician and January 1, 1994 Do Do Patient Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Cyproheptadine Hydrochloride Tablets/Syrup December 1, 1986 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Diclofenac Sodium Delayed-Release Tablets January 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Diltiazem Hydrochloride Extended-Release Capsules September 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Diphenoxylate Hydrochloride and Atropine Sulfate April 1, 1995 Do Do Oral Solution USP -------------------------------------------------------------------------------------------------------------------------------------------------------- Diphenoxylate Hydrochloride and Atropine Sulfate April 1, 1995 Do Do Tablets USP -------------------------------------------------------------------------------------------------------------------------------------------------------- Dipivefrin Hydrochloride Ophthalmic Solution, 0.1% November 2, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Ergoloid Mesylates Tablets January 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Fludeoxyglucose F18 Injection January 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Flurbiprofen Tablets USP January 1, 1994 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Fluvoxamine Maleate Tablets September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Gentamicin Sulfate Ophthalmic Ointment and April 1, 1992 Do Do Solution USP -------------------------------------------------------------------------------------------------------------------------------------------------------- Heparin Sodium Injection USP March 1, 1991 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Hydrocodone Bitartrate and Acetaminophen Tablets April 1, 1994 Do Do USP -------------------------------------------------------------------------------------------------------------------------------------------------------- Hydroxyzine Hydrochloride Injection December 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Hypoglycemic Oral Agents--Federal Register April 1, 1984 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Indomethacin Capsules USP September 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Informal Labeling Guidance Texts for Estrogen Drug August 1, 1992 Do Do Products--Patient Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Informal Labeling Guidance Texts for Estrogen Drug August 1, 1992 Do Do Products--Professional Labeling -------------------------------------------------------------------------------------------------------------------------------------------------------- Isoetharine Inhalation Solution March 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Itraconazole Capsules, USP September 1, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Leucovorin Calcium for Injection July 1, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45459]] Leucovorin Calcium Tablets, USP July 1, 1996 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Local Anesthetics--Class Labeling September 1, 1982 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Meclofenamate Sodium Capsules July 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Medroxyprogesterone Acetate Tablets, USP September 1, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Metaproterenol Sulfate Inhalation Solution USP May 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Metaproterenol Sulfate Syrup USP May 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Metaproterenol Sulfate Tablets May 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Metoclopramide Tablets USP/Oral Solution February 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Naphazoline Hydrochloride Ophthalmic Solution March 1, 1989 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Naproxen Sodium Tablets, USP September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Naproxen Tablets, USP September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Niacin Tablets July 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Paclitaxel Injection February 1, 1991 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Phendimetrazine Tartrate Capsules/Tablets, and February 1, 1991 Do Do Extended-Release Capsules -------------------------------------------------------------------------------------------------------------------------------------------------------- Phentermine Hydrochloride Capsules/Tablets August 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Promethazine Hydrochloride Tablets March 1, 1990 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Propantheline Bromide Tablets August 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Pyridoxine Hydrochloride Injection June 1, 1984 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Quinidine Sulfate Tablets/Capsules USP October 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Ranitidine Tablets USP November 1, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Risperidone Oral Solution September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Risperidone Tablets September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Sulfacetamide Sodium and Prednisolone Acetate January 1, 1995 Do Do Ophthalmic Suspension and Ointment -------------------------------------------------------------------------------------------------------------------------------------------------------- Sulfacetamide Sodium Ophthalmic Solution/Ointment August 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Sulfamethoxazole and Phenazopyridine Hydrochloride February 1, 1992 Do Do Tablets -------------------------------------------------------------------------------------------------------------------------------------------------------- Sulfamethoxazole and Trimethoprim Tablets and Oral August 1, 1993 Do Do Suspension -------------------------------------------------------------------------------------------------------------------------------------------------------- Theophylline Immediate-Release Dosage Forms February 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Theophylline Intravenous Dosage Forms September 1, 1995 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Thiamine Hydrochloride Injection February 1, 1988 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Tobramycin Sulfate Injection USP May 1, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Venlafaxine Hydrochloride Tablets October 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Verapamil Hydrochloride Tablets October 1, 1991 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Vitamin A Capsules February 1, 1992 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45460]] Zolpidem Tartrate Tablets September 1, 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Labeling OTC Human Drug Products Using a Column December 1, 1997 OTC Draft Do Format -------------------------------------------------------------------------------------------------------------------------------------------------------- OTC Actual Use Studies July 22, 1994 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- OTC Nicotine Substitutes March 1, 1994 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) -------------------------------------------------------------------------------------------------------------------------------------------------------- General Guidelines for OTC Combination Products Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Upgrading Category III Antiperspirants to Category Do Do I (43 FR 46728-46731) -------------------------------------------------------------------------------------------------------------------------------------------------------- Photosafety Testing January 10, 2000 Pharmacology/Toxicology Do Draft -------------------------------------------------------------------------------------------------------------------------------------------------------- Format and Content of the Nonclinical Pharmacology/ February 1, 1987 Pharmacology/Toxicology Do Toxicology Section of an Application -------------------------------------------------------------------------------------------------------------------------------------------------------- Nonclinical Pharmacology/Toxicology Development of Do Do Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives -------------------------------------------------------------------------------------------------------------------------------------------------------- Reference Guide for the Nonclinical Toxicity February 1, 1989 Do Do Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies -------------------------------------------------------------------------------------------------------------------------------------------------------- Single Dose Acute Toxicity Testing Toxicity August 26, 1996 Do Do Testing for Pharmaceuticals -------------------------------------------------------------------------------------------------------------------------------------------------------- Applications Covered by Section 505(b)(2) December 8, 1999 Procedural Draft Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Content and Format of New Drug Applications and March 10, 2000 Do Do Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Disclosing Information Provided to Advisory December 22, 1999 Do Do Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000 -------------------------------------------------------------------------------------------------------------------------------------------------------- Information Program on Clinical Trials for Serious March 29, 2000 Do Do or Life-Threatening Diseases: Establishment of a Data Bank -------------------------------------------------------------------------------------------------------------------------------------------------------- Information Request and Discipline Review Letters August 17, 1999 Do Do Under the Prescription Drug User Fee Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Special Protocol Assessment February 9, 2000 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting Debarment Certification Statements October 2, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- 180-Day Generic Drug Exclusivity Under the Hatch- July 14, 1998 Procedural Do Waxman Amendments to the Federal Food, Drug, and Cosmetic Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Advisory Committees: Implementing Section 120 of November 2, 1998 Do Do the Food and Drug Modernization Act of 1997 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45461]] Court Decisions, ANDA Approvals, and 180-Day March 30, 2000 Do Do Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Disclosure of Materials Provided to Advisory November 30, 1999 Do Do Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 -------------------------------------------------------------------------------------------------------------------------------------------------------- Enforcement Policy During Implementation of November 23, 1998 Do Do Section 503A of the Federal Food, Drug, and Cosmetic Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Fast Track Drug Development Programs: Designation, November 18, 1998 Do Do Development, and Application Review -------------------------------------------------------------------------------------------------------------------------------------------------------- Formal Dispute Resolution: Appeals Above the March 7, 2000 Do Do Division Level -------------------------------------------------------------------------------------------------------------------------------------------------------- Formal Meetings With Sponsors and Applicants For March 7, 2000 Do Do PDUFA Products -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation of Section 126 of the FDA July 21, 1998 Do Do Modernization Act of 1997--Elimination of Certain Labeling Requirements -------------------------------------------------------------------------------------------------------------------------------------------------------- National Uniformity for Nonprescription Drugs April 9, 1998 Do Do Ingredient Labeling for OTC Drugs -------------------------------------------------------------------------------------------------------------------------------------------------------- Qualifying for Pediatric Exclusivity Under Section October 1, 1999 Do Do 505A of the Federal Food, Drug, and Cosmetic Act-- Revised -------------------------------------------------------------------------------------------------------------------------------------------------------- Refusal to File July 12, 1993 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Repeal of Section 507 of the Federal Food, Drug, June 15, 1998 Do Do and Cosmetic Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Standards for the Prompt Review of Efficacy May 15, 1998 Do Do Supplements, Including Priority Efficacy Supplements -------------------------------------------------------------------------------------------------------------------------------------------------------- Street Drug Alternatives April 3, 2000 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Women and Minorities Guidance Requirements July 28, 1998 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Information Request and Discipline Review Letters August 17, 1999 User Fee Draft Do Under the Prescription Drug User Fee Act -------------------------------------------------------------------------------------------------------------------------------------------------------- Classifying Resubmissions in Response to Action May 14, 1998 User Fee Do Letters -------------------------------------------------------------------------------------------------------------------------------------------------------- Submitting and Reviewing Complete Responses to May 14, 1998 Do Do Clinical Holds -------------------------------------------------------------------------------------------------------------------------------------------------------- IV. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Grouped by Intended User or Regulatory How to Obtain a Hard Copy of the Document (Name and Name of Document Date of Issuance Activity Address, Phone, FAX, E-mail or Internet) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Program Guidance Manual: Inspection of Medical August 12, 1999 Office of Compliance (OC) Division of Small Manufacturers Assistance; 1-800-638- Devices; Draft 2041 or 301-827-0111 or (FAX) Facts-on-Demand at 1-800- 899-0381 or Internet at http://www.fda.gov/cdrh/ ggpmain.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45462]] Procedures for Laboratory Compliance Testing of May 1, 1986 Do Do Television Receivers-part of TV Packet ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ A Pocket Guide to Device GMP Inspections-Inspections of November 1, 1991 Do Do Medical Device Manufacturers and GMP Regulation Requirements ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ General Principles of Software Validation; Draft Guidance June 9, 1997 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Global Harmonization Task Force Study Group 3-Process February 1, 1999 Do Do Validation Guidance; Final Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Civil Money Penalty Policy; Guidance for FDA Staff June 8, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Medical Device Tracking; Guidance for January 24, 2000 Do Do Industry and FDA Staff [FDAMA] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Enforcement Priorities for Single-Use Devices Reprocessed February 8, 2000 Do Do by Third Parties and Hospitals, Draft Guidance-Not for Implementation; Guidance for Industry and for FDA Staff ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Cover Letter/Guidance Document on the Performance March 9, 1998 Do Do Standard for Electrode Lead Wires and Patient Cable ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Commercial Distribution/Exhibit Letter April 10, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Working Draft of the Current Good Manufacturing Practice July 1, 1995 Do Do (CGMP) Final Rule ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulating In Vitro Diagnostic Device (IVD) Studies; December 17, 1999 Office of Compliance (OC)/Division of Do Guidance; Guidance for FDA Staff Bioresearch Monitoring (DBM) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Preparing Notices of Availability of Investigational March 19, 1999 Do Do Medical Devices and for Recruiting Study Subjects ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ A Guide for the Submission of Abbreviated Radiation March 1, 1996 Office of Compliance (OC)/Division of Do Safety Reports on Cephalometric X-Ray Devices: Defined Enforcement I (DOEI) as Dental Units with an Attachment for Mandible Work that Holds a Cassette and Beam Limiting Device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ A Guide for the Submission of Abbreviated Radiation March 1, 1996 Do Do Safety Reports on Image Receptor Support Devices for Mammographic X-Ray Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ A Guide for the Submission of an Abbreviated Radiation March 1, 1996 Do Do Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Clarification of Radiation Control Regulations for March 1, 1989 Do Do Diagnostic X-Ray Equipment (FDA 89-8221) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ CPG 7133.19: Retention of Microwave Oven Test Record/ August 24, 1981 Do Do Cover Letter: August 24, 1981 Retention of Records Required by 21 CFR 1002 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45463]] Exemption from Reporting and Recordkeeping Requirements September 16, 1981 Do Do for Certain Sunlamp Product Manufacturers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Program Guidance Manual; Field Compliance March 15, 2000 Do Do Testing of Diagnostic (Medical) X-ray Equipment; Guidance for FDA Staff ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Information Disclosure by Manufacturers to October 18, 1999 Do Do Assemblers for Diagnostic X-ray Systems; Guidance for Industry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Electrosurgical Devices and the Application November 15, 1999 Do Do of the Performance Standard for Electrode Lead Wires and Patient Cables ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for the Submission of Initial Reports on Diagnostic January 1, 1982 Do Do X-Ray Systems and their Major Components ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline for the Manufacture of In Vitro Diagnostic January 10, 1994 Do Do Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Medical Device Industry on Endoscopy and May 17, 1993 Do Do Laparoscopy Accessories (Galdi) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Manufacturers/Assemblers of Diagnostic X-ray Systems: October 13, 1993 Do Do Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Abbreviated Reports on Radiation Safety for Microwave August 1, 1995 Office of Compliance (OC)/Division of Do Products (Other Than Microwave Ovens)- E.G. Microwave Enforcement I & III (DOEI & III) Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Abbreviated Reports on Radiation Safety of Non-Medical August 1, 1995 Do Do Ultrasonic Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Filing Annual Reports for X-Ray Components and July 1, 1980 Do Do Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Abbreviated Reports of Microwave and September 1, 1996 Do Do RF Emitting Electronic Products Intended for Medical Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Product Reports for Medical September 1, 1996 Do Do Ultrasound Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Reports on Radiation Safety of March 1, 1985 Do Do Microwave Ovens ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Submission of Information on Accelerators April 1, 1971 Do Do Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Manufacturers and Importers of Microwave Ovens: October 31, 1988 Do Do Information Requirements for Cookbooks and User and Service Manuals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reporting and Compliance Guide for Television Products October 1, 1995 Do Do including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45464]] Reporting Guide for Laser Light Shows and Displays (21 September 1, 1995 Do Do CFR 1002) (FDA 88-8140) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Revised Guide for Preparing Annual Reports on Radiation September 1, 1995 Do Do Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ All U.S. Condom Manufacturers, Importers and Repackagers April 7, 1987 Office of Compliance (OC)/Division of Do Enforcement II (DOEII) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Guide for Laser Products (FDA 86-8260) September 1, 1985 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Condoms: Inspection and Sampling at Domestic April 8, 1987 Do Do Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on April 8, 1987) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Dental Handpiece Sterilization (Dear Doctor Letter) September 28, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene June 23, 1978 Do Do Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Quality System Regulation Information for August 3, 1999 Do Do Various Premarket Submissions; Guidance for Industry; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Quality System Regulation Information for August 3, 1999 Do Do Various Premarket Submissions; Guidance for Industry; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Product Reports for Lasers and September 1, 1995 Do Do Products Containing Lasers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Hazards of Volume Ventilators and Heated Humidifiers September 15, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Latex Labeling Letter (Johnson) March 18, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter--Condom Manufacturers and Distributors April 5, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter--Manufacturers, Distributors and Importers of February 23, 1994 Do Do Condom Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter--Manufacturers, Importers, and Repackagers of February 13, 1989 Do Do Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to All Foreign Manufacturers and Importers of May 28, 1981 Do Do Electronic Products for Which Applicable FDA Performance Standards Exist ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Industry, Powered Wheelchair Manufacturers from May 10, 1993 Do Do RMJohnson ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Manufacturers/Repackers Using Cotton April 22, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to: Manufacturers and Users of Lasers for October 10, 1996 Do Do Refractive Surgery [excimer] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Manufacturers and Initial Distributors of Hemodialyzers May 23, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45465]] Manufacturers and Initial Distributors of Sharps February 3, 1994 Do Do Containers and Destroyers Used by Health Care Professionals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Pesticide Regulation Notice 94-4: Interim Measures for June 30, 1994 Do Do the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Application for a Variance from 21 CFR 1040.11(c) for a July 1, 1998 Office of Compliance (OC)/Division of Do Laser Light Show, Display, or Device [form FDA 3147] Enforcement III (DOEIII) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Computerized Devices/Processes Guidance--Application of May 1, 1992 Do Do the Medical Device GMP to Computerized Devices and Manufacturing Processes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Design Control Guidance for Medical Device Manufacturers March 11, 1997 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Final Design Control Report and Guidance June 1, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of Cabinet X-Ray System February 1, 1975 Do Do Reports Pursuant to 21 CFR 1020.40 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Annual Reports for Ultrasonic Therapy September 1, 1996 Do Do Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Annual Reports on Radiation Safety September 1, 1995 Do Do Testing of Sunlamps and Sunlamp Products (replaces FDA 82-8127) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Annual Reports on Radiation Safety September 1, 1995 Do Do Testing of Mercury Vapor Lamps (replaces FDA 82-8127) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Annual Reports on Radiation Safety October 1, 1987 Do Do Testing of Electronic Products (General) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Product Reports for Ultrasonic August 1, 1996 Do Do Therapy Products (physical therapy only) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Preparing Product Reports on Sunlamps and September 1, 1995 Do Do Sunlamp Products (21 CFR 1002) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Submission of Information on Analytical X-Ray April 30, 1974 Do Do Equipment Required Pursuant to 21 CFR 1002.10 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Submission of Information on Industrial September 1, 1980 Do Do Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Submission of Information on Industrial X-Ray March 1, 1973 Do Do Equipment Required Pursuant to 21 CFR 1002.10 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for the Submission of Initial Reports on Computed September 1, 1984 Do Do Tomography X-Ray Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45466]] Impact Resistant Lenses: Questions and Answers (FDA 87- September 1, 1987 Do Do 4002) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Keeping Medical Devices Safe from Electromagnetic July 1, 1995 Do Do Interference ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Keeping Up With the Microwave Revolution (FDA Pub No. 91- March 1, 1990 Do Do 4160) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Laser Light Show Safety--Who's Responsibility (FDA 86- May 1, 1986 Do Do 8262) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Manufacturers and Importers of Microwave Ovens-- March 28, 1980 Do Do Open Door Operation of Microwave Ovens as a Result of Oven Miswiring ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Trade Association: ReUse of Single-use or December 27, 1995 Do Do Disposable Medical Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter: Policy on Maximum Timer Interval and Exposure August 21, 1986 Do Do Schedule for Sunlamp Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Electromagnetic Interference Issues, Do Do Problem Reports, Standards, and Recommendations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Devices and EMI: The FDA Perspective January 1, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Policy on Lamp Compatability (sunlamps) September 2, 1986 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Policy on Warning Label Required on Sunlamp Products June 25, 1985 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Quality Assurance Guidelines for Hemodialysis Devices February 1, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Quality Control Guide for Sunlamp Products (FDA 88-8234) March 1, 1988 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Quality Control Practices for Compliance with the Federal May 1, 1980 Do Do Mercury Vapor Lamp Performance Standard ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reporting Guide for Product Reports on High Intensity September 1, 1995 Do Do Mercury Vapor Discharge Lamps (21 CFR 1002) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reporting of New Model Numbers to Existing Model Families June 14, 1983 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Safety of Electrically Powered Products: Letter To September 18, 1996 Do Do Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Shielded Trocars and Needles used for Abdominal Access August 23, 1996 Do Do during Laparoscopy ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Suggested State Regulations for Control of Radiation-- January 1, 1982 Do Do Volume II Nonionizing Radiation--Lasers (FDA Pub No. 83- 8220) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Unsafe Patient Lead Wires and Cables September 3, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Imports: Radiation-Producing Electronic Products (FDA 89- November 1, 1988 Do Do 8008) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45467]] Guidance for Industry on the Likelihood of Facilities August 5, 1999 Office of Compliance (OC)/Division of Do Inspections When Modifying Devices Subject to Premarket Program Operations (DOP) Approval ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Medical Device Manufacturer on Pentium February 14, 1995 Office of Compliance (OC)/Office of the Do Processors Center Director (OCD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Sec. 300.600 Commercial Distribution with Regard to September 24, 1987 Do Do Premarket Notification [510(k)] [CPG 7124.19] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to Industry, Powered Wheelchair/Scooter or May 26, 1994 Office of the Center Director (OCD)/ Do Accessory/ Component Manufacturer from Susan Alpert, Office of Device Evaluation (ODE) Ph.D.,M.D. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ General/Specific Intended Use; Guidance for Industry; November 4, 1998 Do Do Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ODE Executive Secretary Guidance Manual August 7, 1987 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Preamendments Class III Strategy; SXAlpert April 19, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Early Collaboration Meetings Under the FDA Modernization February 19, 1998 Do Do Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ``Real-Time'' Review Program for Premarket Approval April 22, 1997 Office of Device Evaluation (ODE) Do Application (PMA) Supplements ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 30-Day Notices and 135-Day PMA Supplements for February 19, 1998 Do Do Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Quality Review Program (Blue Book Memo) March 29, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Convenience Kits Interim Regulatory Guidance (include May 20, 1997 Do Do 874) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Determination of Intended Use for 510(k) Devices Guidance January 30, 1998 Do Do for Industry and CDRH Staff [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Distribution and Public Availability of Premarket October 10, 1997 Do Do Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo #P98-1]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Document Review by the Office of the Chief Counsel (Blue June 6, 1996 Do Do Book Memo G96-1)) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Modifications to Devices Subject to Premarket Approval-- August 6, 1998 Do Do The PMA Supplement Decision Making Process; Guidance for Industry, Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Contents of Product Development Protocol; Guidance for July 27, 1998 Do Do Industry, Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Frequently Asked Questions on The New 510(k) Paradigm; October 22, 1998 Do Do Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45468]] Evidence Models for the Least Burdensome Means to Market; September 1, 1999 Do Do Guidance for Industry and FDA Reviewers; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Supplements to Approved Applications for Class III May 20, 1998 Do Do Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ New Model Medical Device Development Process; Guidance July 21, 1998 Do Do for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Off-the-Shelf Software Use in Medical September 9, 1999 Do Do Devices; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Submitting Reclassification Petition June 1, 1989 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Amended Procedures for Advisory Panel January 26, 1999 Do Do Meetings [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on PMA Interactive Procedures for Day-100 February 19, 1998 Do Do Meetings and Subsequent Deficiencies--For Use by CDRH & Industry [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Use of Standards in Substantial March 12, 2000 Do Do Equivalence Determinations; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Shell Development and Modular Review; Guidances for November 6, 1998 Do Do the Medical Device Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ New Section 513(f)(2)--Evaluation of Automatic Class III February 19, 1998 Do Do Designation, Guidance for Industry and CDRH Staff [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Procedures for Class II Device Exemptions from Premarket February 19, 1998 Do Do Notification, Guidance for Industry and CDRH Staff [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ SMDA Changes-Premarket Notification; Regulatory April 17, 1992 Do Do Requirements for Medical Devices [510(k)] Manual Insert ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The New 510(k) Paradigm-Alternate Approaches to March 20, 1998 Do Do Demonstrating Substantial Equivalence in Premarket Notifications; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 4-of-A-Kind PMA's October 1, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Application of the Device Good Manufacturing Practice December 1, 1983 Do Do (GMP) Regulation to the Manufacture of Sterile Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ CDRH Submissions Coversheet [PMA/PDP/510k/IDE] May 8, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File June 30, 1993 Do Do Policies ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Classified Convenience Kits April 30, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Color Additive Petitions (p. II-19 of PMA Manual) June 1, 1987 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Color Additive Status List (Inspection Operations Manual) February 1, 1989 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45469]] Color Additives for Medical Devices (Snesko) November 15, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Deciding When to Submit a 510(k) for a Change to an January 10, 1997 Do Do Existing Device ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Device Specific Guidance Documents (List) May 11, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ FDA Guide for Validation of Biological Indicator January 1, 1986 Do Do Incubation Time ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ FDA Policy For The Regulation Of Computer Products November 13, 1989 Do Do (DRAFT) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Format for IDE Progress Reports June 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Submissions for May 29, 1998 Do Do Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Preparation of PMA Manufacturing Information August 1, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Establishing and Maintaining a Calibration March 1, 1988 Do Do Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline for the Monitoring of Clinical Investigations January 1, 1988 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline on General Principles of Process Validation May 1, 1987 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline on Sterile Drug Products Produced by Aseptic June 1, 1987 Do Do Processing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline on Validation of the Limulus Amebocyte Lysate December 1, 1987 Do Do (LAL) Test as an End-Product Endotoxin Test ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Indications for Use Statement January 2, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Industry Representatives on Scientific Panels March 27, 1987 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Labeling Reusable Medical Devices for Reprocessing in April 1, 1996 Do Do Health Care Facilities: FDA Reviewer Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Limulus Amebocyte Lysate; Reduction of Samples for October 23, 1987 Do Do Testing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Master Files Part III; Guidance on Scientific and June 1, 1987 Do Do Technical Information ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Electromagnetic Compatibility for Medical Devices: Issues June 13, 1995 Do Do and Solutions; Memorandum ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Methods for Conducting Recall Effectiveness Checks June 16, 1978 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Necessary Information for Diagnostic Ultrasound 510(k) November 24, 1987 Do Do (Draft) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Review Schedule [P87-1] March 31, 1988 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Points to Consider in the Characterization of Cell Lines June 1, 1984 Do Do Used to Produce Biological Products (from John C. Petricciani, M.D.) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45470]] Preamendment Class III Devices March 11, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification [510(k)] Status Request Form, March 14, 1997 Do Do revised ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Preproduction Quality Assurance Planning: Recommendations September 1, 1989 Do Do for Medical Device Manufacturers (FDA 90-4236) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Proposal for Establishing Mechanisms for Setting Review June 30, 1993 Do Do Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated June 25, 1993 Device ``Fast Track'' Plan Announcement (include with 926 930) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Questions and Answers for the FDA Reviewer Guidance: September 3, 1996 Do Do Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Shelf Life of Medical Devices March 1, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Substantial Equivalence (SE) Decision Making January 1, 1990 Do Do Documentation ATTACHED: ``SE'' Decision Making Process (Detailed), i.e., the decision making tree ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Suggested Content for Original IDE Application Cover February 27, 1996 Do Do Letter--Version 4 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Suggestions for Submitting a Premarket Approval (PMA) April 1, 1993 Do Do Application ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Threshold Assessment of the Impact of Requirements for January 1, 1990 Do Do Submission of PMA's for 31 Medical Devices Marketed Prior to May 28, 1976 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Interagency Agreement between FDA & HCFA; #D95-2, September 15, 1995 Office of Device Evaluation (ODE)/ Do Attachment A BlueBook ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Criteria for Categorization of Investigational Devices September 15, 1995 Do Do (HCFA); #D95-2, Attachment B ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Deciding When to Submit a 510(k) for a Change to an January 10, 1997 Do Do Exisiting Device; Blue Book Memo #K97-1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Additional Information Procedures #K93-1 (Blue July 23, 1993 Do Do Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Refuse to Accept Procedures #K94-1 (Blue Book May 20, 1994 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Sign-Off Procedures #K94-2 (Blue Book Memo) June 3, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Sterility Review Guidance and Revision of February 12, 1990 Do Do November18/1994 #K90-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Announcement: Implementation of the FDA/HCFA Interagency September 15, 1995 Do Do Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices #D95-2 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Assignment of Review Documents #I90-2 (Blue Book Memo) August 24, 1990 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45471]] Center for Devices and Radiological Health's June 30, 1993 Do Do Investigational Device Exemption (IDE) Refuse to Accept Policy ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Center for Devices and Radiological Health's Premarket June 30, 1993 Do Do Notification [510(k)] Refuse to Accept Policy--(updated Checklist March 14, 1995) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Clinical Utility and Premarket Approval #P91-1 (Blue Book May 3, 1991 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Consolidated Review of Submissions for Diagnostic October 19, 1990 Do Do Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Consolidated Review of Submissions for Lasers and October 19, 1990 Do Do Accessories #G90-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Continued Access to Investigational Devices During PMA July 15, 1996 Do Do Preparation and Review (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Cover Letter: 510(k) Requirements During Firm-Initiated November 21, 1995 Do Do Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo #K95- 1) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Criteria for Panel Review of PMA Supplements #P86-3 (Blue January 30, 1986 Do Do Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Delegation of IDE Actions #D88-1 (Blue Book Memo) April 26, 1988 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Device Labeling Guidance #G91-1 (Blue Book Memo) March 8, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Document Review Processing #I91-1 (Blue Book Memo) February 12, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Documentation and Resolution of Differences of Opinion on December 23, 1993 Do Do Product Evaluations #G93-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Executive Secretaries Guidance Manual #G87-3 August 7, 1987 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Goals and Initiatives for the IDE Program #D95-1 (Blue July 12, 1995 Do Do Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Center for Devices and Radiological June 30, 1986 Do Do Health's Premarket Notification Review Program #K86-3 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ HCFA Reimbursement Categorization Determinations for FDA- October 31, 1995 Do Do approved IDEs ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo) May 20, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Integrity of Data and Information Submitted to ODE #I91-2 May 29, 1991 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Meetings with the Regulated Industry #I89-3 (Blue Book November 20, 1989 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45472]] Memorandum of Understanding Regarding Patient Labeling August 9, 1996 Do Do Review (Blue Book Memo #G96-3)) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Nondisclosure of Financially Sensitive Information #I92-1 March 5, 1992 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ODE Regulatory Information for the Office of Compliance-- May 15, 1987 Do Do Information Sharing Procedures #G87-2 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Overdue IDE Annual Progress Report Procedures #D93-1 July 23, 1993 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Panel Report and Recommendations on PMA Approvals #P86-5 April 18, 1986 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Panel Review of ``Me-Too'' Devices #P86-6 (Blue Book July 1, 1986 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Panel Review of Premarket Approval Applications #P91-2 May 3, 1991 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Compliance Program #P91-3 (Blue Book Memo) May 3, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Filing Decisions #P90-2 (Blue Book Memo) May 18, 1990 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Refuse to File Procedures #P94-1 (Blue Book Memo) May 20, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Supplements: ODE letter to manufacturers; identifies April 24, 1990 Do Do situations which may require the submission of a PMA supplement (When PMA Supplements are Required) #P90-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA/510(k) Triage Review Procedures #G94-1 (Blue Book May 20, 1994 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA's--Early Review and Preparation of Summaries of January 27, 1986 Do Do Safety and Effectiveness #P86-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Policy Development and Review Procedures #I90-1 (Blue February 15, 1990 Do Do Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Approval Application (PMA) Closure #P94-1 (Blue July 8, 1994 Do Do Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification--Consistency of Reviews #K89-1 February 28, 1989 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review and Approval of PMA's of Licensees #P86-4 (Blue October 22, 1990 Do Do Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review of 510(k)s for Computer Controlled Medical Devices August 29, 1991 Do Do #K91-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review of Final Draft Medical Device Labeling #P91-4 August 29, 1991 Do Do (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review of IDEs for Feasibility Studies #D89-1 (Blue Book May 17, 1989 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review of Laser Submissions #G88-1 (Blue Book Memo) April 15, 1988 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45473]] Telephone Communications Between ODE Staff and January 29, 1993 Do Do Manufacturers #I93-1 (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Toxicology Risk Assessment Committee #G89-1 (Blue Book August 9, 1989 Do Do Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Use of International Standard ISO-10993, ``Biological May 1, 1995 Do Do Evaluation of Medical Devices Part 1: Evaluation and Testing'' (Replaces #G87-1 #8294) (Blue Book Memo) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Points to Consider for Portable Blood Glucose Monitoring February 20, 1996 Office of Device Evaluation (ODE)/ Do Devices Intended for Bedside Use in the Neonate Nursery Division of Clinical Laboratory Devices (DCLD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Letter to IVD Manufacturers on Streamlined PMA; Final December 22, 1997 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Assessing the Safety/Effectiveness of Home-use In Vitro October 1, 1988 Do Do Diagnostic Devices (IVD's): Points to Consider Regarding Labeling and Premarket Submissions; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Data for Commercialization of Original Equipment June 10, 1996 Do Do Manufacturer, Secondary and Generic Reagents for Automated Analyzers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Criteria for Assessment of In Vitro Diagnostic Devices August 31, 1995 Do Do for Drugs of Abuse Assays Using Various Methodologies; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for 510(k) Submission of Fecal Occult July 29, 1992 Do Do Blood Tests; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for 510(k) Submission of September 30, 1991 Do Do Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for 510(k) Submission of September 1, 1992 Do Do Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for 510(k) Submission of Lymphocyte September 26, 1991 Do Do Immunophenotyping IVDs using Monoclonal Antibodies; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Approval Applications for Assays Pertaining to October 8, 1999 Do Do Hepatitis C Viruses (HCV) that are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Nucleic Acid Amplification Based In June 14, 1993 Do Do Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarketing Approval Review Criteria for Premarket September 10, 1992 Do Do Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) with Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bi; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Criteria for Cyclosporine PMA's January 24, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45474]] Guidance Document for the Submission of Tumor Associated September 19, 1996 Do Do Antigen Premarket Notification [510(k)] to FDA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for 510(k)s on Cholesterol Tests for Clinical July 14, 1995 Do Do Laboratory, Physicians' Office Laboratory, and Home Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--Abbreviated 510(k) Submissions for February 22, 1999 Do Do In Vitro Diagnostic Calibrators; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Document for Special Controls for Erythropoietin Assay April 28, 1999 Do Do Premarket Notifications [510(k)s] Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Premarket Submissions for Kits for Screening December 30, 1998 Do Do Drugs of Abuse to Be Used By The Consumer; Guidance for Industry; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Labeling for Laboratory Tests; Guidance for June 24, 1999 Do Do Industry; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test July 6, 1998 Do Do System; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Chloride Test System; Guidance for July 6, 1998 Do Do Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic C-Reactive Protein Immunological Test July 20, 1998 Do Do System; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Creatinine Test System; Guidance for July 2, 1998 Do Do Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Glucose Test System; Guidance for July 6, 1998 Do Do Industry ; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--In Vitro Diagnostic Potassium Test July 6, 1998 Do Do System; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Sodium Test System; Guidance for July 6, 1998 Do Do Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Urea Nitrogen Test System; Guidance July 6, 1998 Do Do for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Points to Consider Guidance Document on Assayed and February 3, 1999 Do Do Unassayed Quality Control Material; Guidance for Industry; ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; April 27, 1999 Do Do Guidance for Industry and FDA Reviewers/Staff; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Labeling for Over-the-Counter Sample December 21, 1999 Do Do Collection Systems for Drugs of Abuse Testing; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Submission of Immunohistochemistry June 3, 1998 Do Do Applications to the FDA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Points to Consider for Cervical Cytology Devices July 25, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Points to Consider for Collection of Data in Support of September 26, 1994 Do Do In-Vitro Device Submissions for 510(k) Clearance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45475]] Points to Consider for Hematology Quality Control September 30, 1997 Do Do Materials ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Points to Consider for Review of Calibration and Quality February 1, 1996 Do Do Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated March 14/1996 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Alpha-Fetoprotein (AFP) July 15, 1994 Do Do in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Review Criteria for Assessment of March 8, 2000 Do Do Antimicrobial Susceptibility Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Antimicrobial October 30, 1996 Do Do Susceptibility Test Discs ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Cytogenetic Analysis July 15, 1991 Do Do Using Automated and Semi-Automated Chromosome Analyzers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Human Chorionic September 27, 1995 Do Do Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of In Vitro Diagnostic July 6, 1993 Do Do Devices for Direct Detection of Mycobacterium Spp. Tuberculosis [(TB)] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of In Vitro Diagnostic January 1, 1992 Do Do Devices for Direct Detection of Chlamydiae in Clinical Specimens ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Laboratory Tests for September 17, 1992 Do Do the Detection of Antibodies to Helicobacter pylori ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Portable Blood Glucose February 14, 1996 Do Do In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Assessment of Rheumatoid Factor(RF) February 21, 1997 Do Do In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Blood Culture Systems August 12, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Devices Assisting in the Diagnosis of May 31, 1990 Do Do C. Difficile Associated Diseases ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for Devices Intended for the Detection of December 30, 1991 Do Do Hepatitis B ``e'' Antigen and Antibody to Hbe ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for In Vitro Diagnostic Devices for August 1, 1992 Do Do Detection of IGM Antibodies to Viral Agents ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45476]] Review Criteria for In Vitro Diagnostic Devices for the February 1, 1994 Do Do Assessment of Thyroid Autoantibodies using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA). ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for In Vitro Diagnostic Devices that February 15, 1996 Do Do Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria For Premarket Approval of In Vitro May 15, 1992 Do Do Diagnostic Devices for Detection of Antibodies to Parvovirus B19 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for the Assessment of Allergen-Specific March 2, 1993 Do Do Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using Immunological Test Methodologies ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Criteria for the Assessment of Anti-nuclear September 1, 1992 Do Do Antibodies (ANA) In-Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA). ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry and FDA; Guidance for Indwelling February 21, 2000 Office of Device Evaluation (ODE)/ Do Blood Gas Analyzer 510(k) Submissions Division of Cardiovascular, Respiratory & Neurological Devices (DCRND) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Balloon Valvuloplasty Guidance For The Submission Of an January 1, 1989 Do Do IDE Application and a PMA Application ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Battery Guidance July 12, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Carotid Stent--Suggestions for Content of Submissions to October 26, 1996 Do Do the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Coronary and Cerebrovascular Guidewire Guidance January 1, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(K) Submission Requirements for Peak Flow Meters; January 13, 1994 Do Do Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Emergency Resuscitator Guidance; Draft April 14, 1993 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Implantable Cardioverter-Defibrillators; June 24, 1996 Do Do Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of Research and Marketing August 1, 1993 Do Do Applications for Vascular Graft Prostheses; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of Research and Marketing May 1, 1995 Do Do Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: Human Heart Valve Allografts; Draft June 21, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45477]] Intravascular Brachytherapy--Guidance for Data to be May 24, 1996 Do Do Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Percutaneous Transluminal Coronary Angioplasty Package February 7, 1995 Do Do Insert Template; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Replacement Heart Valve Guidance; Draft October 14, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewer Guidance for Ventilators; Draft July 1, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewer Guidance on Face Masks and Shield for CPR; Draft March 16, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Cardiac Ablation Preliminary Guidance (Data to be March 1, 1995 Do Do Submitted to the FDA in Support Investigation Device Exemption Application; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Electrode Recording Catheter Preliminary Guidance (Data March 1, 1995 Do Do to be Submitted to the FDA in Support of Premarket Notifications [510(k)s]) ; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Excerpts Related to EMI from November 1993 Anesthesiology November 1, 1993 Do Do and Respiratory Devices Branch/EMC Standard for Medical Devices (to be used with EMI Standard) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ General Guidance Document: Non-Invasive Pulse Oximeter September 7, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document: Electrocardiograph (ECG) Surface February 11, 1997 Do Do Electrode Tester--Version 1.0 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Premarket Notification Submission January 24, 2000 Do Do for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Vascular Prostheses 510(k) November 26, 1999 Do Do Submission; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Annuloplasty Rings 510(k) Submissions; Final November 26, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Cardiopulmonary Bypass Arterial Line Blood February 21, 2000 Do Do Filter 510(k) Submissions; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Cardiopulmonary Bypass Oxygenators 510(k) January 17, 2000 Do Do Submissions; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Cardiovascular Intravascular Filter 510(k) November 26, 1999 Do Do Submission; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Extracorporeal Blood Circuit Defoamer 510(k) February 16, 2000 Do Do Submissions; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Cardiac Monitor Guidance (including Cardiotachometer and November 5, 1998 Do Do Rate Alarm); Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Diagnostic ECG Guidance (Including Non-Alarming ST November 5, 1998 Do Do Segment Measurement); Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45478]] Recommended Clinical Study Design for Ventricular May 7, 1999 Do Do Tachycardia Ablation; Guidance for Industry and for FDA Reviewers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Oxygen Conserving Device 510(k) Review 73 February 1, 1989 Do Do BZD 868.5905 Non-continuous Ventilator Class II ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Peak Flow Meters for Over-the-Counter Sale June 23, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of the Annual Report to the April 1, 1990 Do Do PMA Approved Heart Valve Prostheses ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of 510(k) Premarket February 11, 1997 Do Do Notifications for Electrocardiograph (ECG) Electrode Version 1.0 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of 510(k) Premarket February 11, 1997 Do Do Notifications for Electrocardiograph (ECG) Lead Switching Adapter Version 1.0 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of Research and Marketing January 14, 2000 Do Do Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Heated Humidifier Review Guidance August 30, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Implantable Pacemaker Testing Guidance January 12, 1990 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Vascular Graft Manufacturer, Developer, or May 11, 1990 Do Do Representative; Letter/Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Labeling--Suggested Format and Content; April 25, 1997 Do Do Draft Document ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Non-Invasive Blood Pressure (NIBP) Monitor Guidance March 10, 1997 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Policy for Expiration Dating (DCRND RB92-G) October 30, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Review Guidelines for Oxygen Generators and Oxygen April 14, 1993 Do Do Equipment; Draft Document ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewer Guidance for Nebulizers, Metered Dose Inhalers, October 1, 1993 Do Do Spacers and Actuators ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewer Guidance for Nebulizers, Metered Dose Inhalers, November 9, 1990 Do Do Spacers and Actuators ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewer's Guidance for Oxygen Concentrator August 30, 1991 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Conducting Stability Testing to Support an November 16, 1999 Office of Device Evaluation (ODE)/ Do Expiration Date Labeling Claim for Medical Gloves; Draft Division of Dental, Infection Control and General Hospital Devices (DDIGD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Devices for the Treatment and/or Diagnosis of June 10, 1998 Do Do Temporomandibular Joint Dysfunction and/or Orofacial Pain; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content and Format of Premarket November 5, 1998 Do Do Notification [510(k)] Submission of Washers and Washer- Disinfectors; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45479]] Guidance Document for Washers and Washer-Disinfectors June 2, 1998 Do Do Intended for Processing Reusable Medical Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Overview of Information Necessary for Premarket April 21, 1999 Do Do Notification Submissions for Endoseous Implants; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reprocessing and Reuse of Single-Use Devices: Review February 8, 2000 Do Do Prioritization Scheme; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Premarket Notification [510(k)] Submissions September 19, 1995 Do Do for Sterilizers Intended for Use in Health Care Facilities; Addendum ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket March 3, 1997 Do Do Notification [510(k)'S] for Dental Alloys; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Supplementary Guidance on the Content of Premarket March 1, 1995 Do Do Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick); Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance and Format of Premarket Notification [510(k)] January 3, 2000 Do Do Submissions for Liquid Chemical Sterilants/High Level Disinfectants; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document on Dental Handpieces July 1, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification [510(k)] Submissions for Testing January 13, 1999 Do Do for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Testing for Sensitizing Chemicals in Natural Rubber Latex July 27, 1997 Medical Devices; (Addendum to Premarket Notification [510(k) Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Neonatal and Neonatal Transport Incubators-Premarket September 18, 1998 Do Do Notifications; Guidance for Industry and FDA Reviewers; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Dental Cements Premarket Notification; Final August 18, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance For The Arrangement and Content of a Premarket May 16, 1989 Do Do Approval (PMA) Application For An Endosseous Implant For Prosthetic Attachment ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of a Premarket Notification November 27, 1998 Do Do [510(k)] for Direct Filling Dental Composites ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of Premarket Notification April 1991 Do Do [510(k)] for Resorbable Periodontal Barriers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on 510(k) Submissions for Implanted Infusion October 1, 1990 Do Do Ports ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45480]] Guidance on Premarket Notification [510(k)] Submissions August 1, 1993 Do Do for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Premarket Notification [510(K)] Submissions March 16, 1995 Do Do for Short-Term and Long-Term Intravascular Catheters ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Premarket Notification [510(k)] Submissions March 1, 1993 Do Do for Sterilizers Intended for Use in Health Care Facilities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Premarket Notification [510(k)] Submissions August 1, 1993 Do Do for Surgical Gowns and Surgical Drapes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content and Format of Premarket February 13, 1998 Do Do Notification [510(k)] for Testing for Skin Sensitization to Chemicals in Latex Products [Draize Testing] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content and Format of Premarket October 1, 1993 Do Do Notification [510(k)] Submissions for Sharps Containers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content and Format of Premarket October 1, 1993 Do Do Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of March 9, 1994) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content and Format of Premarket December 6, 1996 Do Do Notification 510(k) Submissions for Liquid Chemical Germicides ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content of Premarket Notification December 1, 1995 Do Do [510(k)] Submissions for Protective Restraints ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content of Premarket Notification April 1, 1993 Do Do [510(K)] Submissions for Hypodermic Single Lumen Needles ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content of Premarket Notification April 1, 1993 Do Do [510(K)] Submissions for Piston Syringes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content of Premarket Notification March 1, 1993 Do Do [510(K)] Submissions for Clinical Electronic Thermometers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content of Premarket Notification March 1, 1993 Do Do [510(k)] Submissions for External Infusion Pumps ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Dental Impression Materials Premarket Notification; Final August 17, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ OTC Denture Cushions, Pads, Reliners, Repair Kits and August 18, 1998 Do Do Partially Fabricated Denture Kits; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Information Necessary for Premarket Notification December 9, 1996 Do Do Submissions For Screw-Type Endossesous Implants ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Information Needed for Hydroxyapatite Coated February 20, 1997 Office of Device Evaluation (ODE)/ Do Orthopedic Implants Division of General & Restorative Devices (DGRD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45481]] Alternate Suture Labeling Resulting From the January 11, January 11, 1993 Do Do 1993 Meeting with HIMA (Reformatted December 17, 1997) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Calcium Phosphate (Ca-P) Coating Draft Guidance for February 21, 1997 Do Do Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Copy of October 9, 1992 Letter and Original Suture October 9, 1992 Do Do Labeling Guidance (Reformatted December 17, 1997) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Guideline for General Surgical Electrosurgical May 10, 1995 Do Do Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Data Requirements for Ultrahigh Molecular Weight March 28, 1995 Do Do Polyethylene (Uhmupe) Used in Orthopedic Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Femoral Stem Prostheses; Draft August 1, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Testing Acetabular Cup Prostheses; May 1, 1995 Do Do Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 16, 1997 Do Do Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Arthroscopes and Accessory 510(k)s; Draft May 1, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Testing MR Interaction with Aneurysm Clips; May 22, 1996 Do Do Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of a Premarket Notification May 31, 1995 Do Do for a Non-Interactive Wound and Burn Dressing [510(k)] ; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of a Premarket Notification August 30, 1994 Do Do for Extended Laparoscopy Devices (ELD); Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of an IDE Submission for a April 4, 1995 Do Do Interactive Wound and Burn Dressing; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of Premarket Notifications April 1, 1993 Do Do [510(k)] s for Cemented, Semi-Constrained Total Knee Prostheses; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Outline for a Guidance Document for Testing Orthopedic November 1, 1993 Do Do Bone Cement, request for comments by December 10, 1993; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification Review Guidance for Evoked June 1, 1994 Do Do Response Somatosensory Stimulators; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Biocompatibility Requirements for Long Term September 12, 1994 Do Do Neurological Implants: Part-3 Implant Model; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Biofeedback Devices--Guidance for 510(k) Content; Draft August 1, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Cranial Perforator Guidance; Draft July 13, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45482]] Guidance for Clinical Data to be Submitted for Premarket August 20, 1992 Do Do Approval Application for Cranial Electrotherapy Stimulators; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for Cortical Electrode 510(k) Content; Draft August 10, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Neuro Endoscope Guidance; Draft July 7, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Electroencephalograph Devices Guidance for 510(k) November 3, 1997 Do Do Content; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Galvanic Skin Response Measurement Devices-Draft Guidance August 1, 1994 Do Do for 510(k) Content ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of IDEs for Spinal January 13, 2000 Do Do Systems; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Preparation of Investigational Device Exemptions and March 18, 1998 Do Do Premarket Approval Applications for Bone Growth Stimulator Devices; Guidance Document for Industry and CDRH Staff; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Surgical Lamp 510Ks; Final July 13, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Testing Biodegradable Polymer April 20, 1996 Do Do Implant Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Testing Bone Anchor Devices; Draft April 20, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Testing Non-Articulating, May 1, 1995 Do Do ``Mechanically Locked'', Modular Implant Components; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Testing Orthopedic Implants with April 28, 1994 Do Do Modified Metallic Surfaces Apposing Bone or Bone Cement (replaces 8623 and 8093) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of IDE and PMA February 18, 1993 Do Do Applications for Intra-Articular Prosthetic Knee Ligament Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Electromyograph Needle Electrodes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Exercise Equipment ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Beds ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45483]] Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Immersion Hydrobaths ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Therapeutic Massagers and Vibrators ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for the Preparation of Premarket July 26, 1995 Do Do Notification [510(k)] Applications for Heating and Cooling Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document For The Preparation of Premarket January 10, 1995 Do Do Notification For Ceramic Ball Hip Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Dura Substitute Devices; Final August 13, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Neurological Embolization Devices; August 13, 1999 Do Do Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of a Premarket Notification August 30, 1999 Do Do Application for Processed Human Dura Mater; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Dermabrasion Devices; Final March 2, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Preclinical and Clinical Data and Labeling October 5, 1999 Do Do for Breast Prostheses; Guidance for Industry; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Spinal System 510(k)s; Final May 7, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Powered Suction Pump 510(k)s; October 30, 1998 Do Do Guidance for Industry and/or for FDA Reviewers/Staff and/ or Compliance; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Powered Muscle Stimulator 510(k)s; June 9, 1999 Do Do Guidance for Industry, FDA Reviewers/Staff and Compliance; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for April 28, 1998 Do Do Esophageal and Tracheal Prostheses; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Studies for Pain Therapy Devices--General May 12, 1988 Do Do Considerations in the Design of Clinical Studies for Pain-Alleviating Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Preparation of a Premarket Notification March 2, 1999 Do Do Application for a Surgical Mesh; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45484]] Guidance on the Content and Organization of a Premarket June 1, 1995 Do Do Notification for a Medical Laser ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide for TENS 510(k) Content; Draft August 1, 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidelines for Reviewing Premarket Notifications that February 1997 Do Do Claim Substantial Equivalence to Evoked Response Stimulators ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Core Study for Silicone Breast Implants; Letter January 11, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ORDB 510(k) Sterility Review Guidance July 3, 1997 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Protocol for Dermal Toxicity Testing for Devices in January 1985 Do Do Contact with Skin; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewers Guidance Checklist for Intramedullary Rods February 21, 1997 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewers Guidance Checklist for Orthopedic External February 21, 1997 Do Do Fixation Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification [510(k)] Guidance Document for June 28, 1994 Office of Device Evaluation (ODE)/ Do Class II Daily Wear Contact Lenses; Amendment 1; Draft Division of Ophthalmic Devices (DOD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Premarket Submission of Orthokeratology April 10, 2000 Do Do Rigid Gas Permeable Contact Lenses; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ An FDA Survey of U.S. Contact Lens Wearers (Carol L. July 1, 1987 Do Do Herman) Reprinted from Contact Lens Spectrum ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Announcement by Dr. Alpert at July 26, 1996 Ophthalmic August 26, 1996 Do Do Panel Meeting concerning Manufacturers & Users of Lasers for Refractive Surgery [Excimer] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Announcement: Information for Manufacturers & Users of September 22, 1997 Do Do Lasers for Refractive Surgery [Excimer] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Checklist of Information Usually Submitted in an October 10, 1996 Do Do Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Contact Lenses: The Better the Care the Safer the Wear; April 1, 1991 Do Do Publication No. FDA 91-4220 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Discussion Points for Expansion of the ``Checklist of September 5, 1997 Do Do Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers''; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification [510(k)] Guidance Document for May 12, 1994 Do Do Class II Daily Wear Contact Lenses and June 28, 1994 corrections to pages 18 & 20; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification 510(k) Guidance for Contact Lens May 1, 1997 Do Do Care Products; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Facts for Consumers from the Federal Trade Commission- April 1, 1986 Do Do Eyeglasses ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45485]] FDA Guidelines for Multifocal Intraocular Lens IDE May 29, 1997 Do Do Studies and PMA's ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Ophthalmoscope Guidance (Direct and Indirect); Guidance July 8, 1998 Do Do for Industry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Document for Nonprescription Sunglasses; Final October 9, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Retinoscope Guidance; Final July 8, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Slit Lamp Guidance; Final July 13, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Revised Procedures for Adding Lens Finishing Laboratories August 11, 1998 Do Do to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Guidance for Industry and FDA Staff; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Accountability Analysis for Clinical Studies for August 4, 1999 Do Do Ophthalmic Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Aqueous Shunts--510(k) Submissions; Final November 16, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on 510(k) Submissions for Keratoprostheses; March 3, 1999 Do Do Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Content and Format of Premarket January 16, 1998 Do Do Notification [510(k)] Submissions for Surgical Mask; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Important Information About Rophae Intraocular Lenses August 20, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Intraocular Lens (IOL) Guidance Document; Draft October 14, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ New FDA Recommendations & Results of Contact Lens Study May 30, 1989 Do Do (7 Day Letter) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Owners Certification of Lasers as PMA Approved Devices September 26, 1996 Do Do Excimer] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Third Party Review Guidance for Vitreous Aspiration and January 31, 1997 Do Do Cutting Device Premarket Notification [510(k)] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Update on Excimer Lasers for Nearsightedness May 20, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Manufacturers Seeking Marketing Clearance of March 12, 2000 Do Do Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Sterile Lubricating Jelly Used With September 19, 1994 Office of Device Evaluation (ODE)/ Do Transurethral Surgical Instruments Division of Reproductive, Abdominal, ENT & Radiological Devices (DRAERD) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Hemodialyzer Reuse Labeling; Draft November 6, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Content of Premarket Notification for Hemodialysis August 7, 1998 Do Do Delivery Systems; Guidance for Industry and CDRH Reviewers; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45486]] Guidance for the Content of Premarket Notifications February 8, 1999 Do (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ CDRH Interim Regulatory Policy for External Penile September 10, 1997 Do Do Rigidity Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Checklist for Mechanical Lithotripters and Stone November 1, 1994 Do Do Dislodgers used in Gastroenterology and Urology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Conditioned Response Enuresis November 23, 1994 Do Do Alarms; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Condom Catheters; Draft February 23, 1995 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Endoscopic Electrosurgical Unit August 16, 1995 Do Do (ESU) and Accessories Used in Gastroenterology and Urology; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Endoscopic Light Sources Used in June 22, 1995 Do Do Gastroenterology and Urology; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Non-Implanted Electrical Stimulators June 6, 1995 Do Do Used for the Treatment of Urinary Incontinence; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Checklist for Urological Irrigation System and August 1, 1995 Do Do Tubing Set; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Clinical Investigations of Devices Used for November 11, 1994 Do Do the Treatment of Benign Prostatic Hyperplasia (BPH); Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Information on Clinical Safety and February 5, 1992 Do Do Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Preclinical and Clinical Investigations of November 29, 1995 Do Do Urethral Bulking Agents Used in the Treatment of Urinary Incontinence; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Preparation of PMA Applications for Penile March 16, 1993 Do Do Inflatable Implants; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Preparation of PMA Applications for March 16, 1993 Do Do Testicular Prostheses; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Preparation of PMA Applications for the May 1, 1995 Do Do Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter); Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Review of Bone Densitometer 510(k) November 9, 1992 Do Do Submissions; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Clinical Investigation of Urethral November 2, 1995 Do Do Stents; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for March 17, 1995 Do Do Endoscopes used in Gastroenterology and Urology; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45487]] Guidance for the Content of Premarket Notifications for July 29, 1991 Do Do Loop and Rollerball Electrodes for GYN Electrosurgical Excisions; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for May 25, 1995 Do Do Menstrual Tampons; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for January 24, 1992 Do Do Urological Balloon Dilatation Catheters; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for May 30, 1997 Do Do Water Purification Components and Systems for Hemodialysis; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance Outline-Points to Consider for Clinical Studies November 30, 1993 Do Do for Vasovasostomy Devices; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance to Firms on Biliary Lithotripsy Studies; Draft August 2, 1990 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Suggested Information for Reporting Extracorporeal Shock January 18, 1991 Do Do Wave Lithotripsy Device Shock Wave Measurements; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Thermal Endometrial Ablation Devices (Submission Guidance March 14, 1996 Do Do for an IDE); Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Devices Used for In Vitro Fertilization and Related September 10, 1998 Do Do Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft Availability ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for November 30, 1998 Do Do Intracorporeal Lithotripters; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance (``Guidelines'') for Evaluation of Fetal Clip March 8, 1977 Do Do Electrode ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance (``Guidelines'') for Evaluation of Hysteroscopic May 10, 1978 Do Do Sterilization Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance (``Guidelines'') for Evaluation of Laparoscopic May 1978 Do Do Bipolar and Thermal Coagulators (and Accessories) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance (``Guidelines'') for Evaluation of Tubal November 22, 1977 Do Do Occlusion Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of Premarket Notifications December 3, 1998 Do Do for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of Premarket Notifications November 20, 1998 Do Do for Radionuclide Dose Calibrators; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of Premarket Notifications November 14, 1998 Do Do for Magnetic Resonance Diagnostic Devices; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45488]] Harmonic Imaging With/Without Contrast Premarket November 16, 1998 Do Do Notification; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Non-Automated Sphygmomanometer (Blood Pressure Cuff) November 19, 1998 Do Do Guidance; Version 1; Guidance for Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Uniform Contraceptive Labeling; Guidance for Industry; July 23, 1998 Do Do Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for January 16, 2000 Do Do Penile Rigidity Implants; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Electro-optical Sensors for the In Vivo Detection of August 25, 1999 Do Do Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Guidance for Industry; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Noise Claims in Hearing Aid Labeling; Final October 21, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Magnetic Resonance Diagnostic Devices-- September 29, 1997 Do Do Criteria for Significant Risk Investigations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Resorbable Adhesion Barrier Devices for Use December 16, 1999 Do Do in Abdominal and/or Pelvic Surgery; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Arrangement and Content of a Premarket May 1, 1990 Do Do Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Comment and Review of 510(k) August 1, 1993 Do Do Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for February 10, 1993 Do Do Biopsy Devices Used in Gastroenterology and Urology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for September 12, 1994 Do Do Conventional and Antimicrobial Foley Catheters ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for February 5, 1998 Do Do Metal Expandable Biliary Stents; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for February 10, 1993 Do Do Urethral Stents ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for June 7, 1994 Do Do Urine Drainage Bags ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Content of Premarket Notifications for July 29, 1994 Do Do Urodynamic/Uroflowmetry Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Submission of 510(k)'s for Solid State X- August 6, 1999 Do Do ray Imaging Devices; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for the Technical Content of a Premarket April 1, 1990 Do Do Approval (PMA) Application for an Endolymphatic Shunt Tube with Valve ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45489]] Guidance for the Content of Premarket Notifications for August 7, 1998 Do Do Conventional and Permeability Hemodialyzers; Guidance to Industry and CDRH Reviewers; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline for the Arrangement and Content of a Premarket May 1, 1990 Do Do Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidelines for Evaluation of Non-Drug IUD's September 28, 1976 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Home Uterine Activity Monitors: Guidance for the July 30, 1999 Do Do Submission of 510(k) Premarket Notifications; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Hysteroscopes and Gynecology Laparoscopes--Submission March 27, 1996 Do Do Guidance for a 510(k) includes 00192 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Hysteroscopic and Laparoscopic Insufflators: Submission August 1, 1995 Do Do Guidance for a 510(k) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Information for a Latex Condom 510(k) Submission for July 1, 1997 Do Do Obstetrics-Gynecology Devices Branch; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Information for Manufacturers Seeking Marketing Clearance September 30, 1997 Do Do of Diagnostic Ultrasound Systems and Transducers; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Intrapartum Continuous Monitors for Fetal Oxygen June 14, 1997 Do Do Saturation and Fetal pH; Submission Guidance for a PMA; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Latex Condoms for Men-Information for 510(k) Premarket July 23, 1998 Do Do Notifications: Use of Consensus Standards for Abbreviated Submissions ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Notice to Manufacturers of Bone Mineral Densitometers; September 25, 1997 Do Do Letter ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Testing Guidelines for Falloposcopes November 20, 1992 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Testing Guidelines for Female Barrier April 4, 1990 Do Do Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Reviewer Guidance for Automatic X-Ray Film Processor February 1, 1990 Do Do 510(k) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Simplified 510(k) Procedures For Certain Radiology December 21, 1993 Do Do Devices (December 21, 1993 letter from L Yin, ODE/ DRAERD, to NEMA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Information for Manufacturers Seeking Marketing Clearance June 19, 1996 Do Do of Digital Mammography Systems; Status Update ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Testing Guidance for Male Condoms Made from New Material June 29, 1995 Do Do (Non-Latex) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Tympanostomy Tubes Submission Guidance for a 510(k) January 14, 1998 Do Do Premarket Notification; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45490]] Guidance on Amended Procedures for Advisory Panel March 20, 1998 ODE/Program Operations Staff (POS) Do Meetings [FDAMA] Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA/510(k) Expedited Review-Guidance for Industry and March 20, 1998 Do Do CDRH Staff [FDAMA] Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA/510(k) Expedited Review #G98-4 (Blue Book Memo) March 20, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on IDE Policies and Procedures [FDAMA]; Final January 20, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ FDA Modernization Act of 1997 Guidance for the Device February 6, 1998 Office of Health and Industry Programs Do Industry on Implementation of Highest Priority (OHIP) Provisions [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Overview of FDA Modernization Act of 1997 Medical Device June 5, 1998 Do Do Provisions [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: The Mammography Quality Standards Act Final March 4, 1999 Office of Health and Industry Programs Do Regulations Document #1; Final (OHIP)/Division of Mammography Quality and Radiation Programs (DMQRP) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: The Mammography Quality Standards Act Final February 25, 2000 Do Do Regulations Document #2; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: The Mammography Quality Standards Act Final December 8, 1999 Do Do Regulations Document #3; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance The Mammography Quality Standards Act Final May 5, 1999 Do Do Regulations--Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance The Mammography Quality Standards Act Final May 5, 1999 Do Do Regulations--Preparing for MQSA Inspections; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Request and Issuance of Interim Notice May 4, 1999 Do Do Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b); Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Review of Cases of Possible Suspension or March 26, 1998 Do Do Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42 U.S.C. 263(b); Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Review of Requests for Reconsideration of March 26, 1998 Do Do Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S. C. 263(b); Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Submission of Request for Reconsideration of March 26, 1998 Do Do Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b); Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45491]] Accidental Radioactive Contamination of Human Food and August 13, 1998 Do Do Animal Feeds: Recommendations for State and Local Agencies; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Policy and Standard Operating Procedures April 15, 1998 Do Do When Mammography Facilities in States that Have Accreditation Bodies Intend to Change Accreditation Bodies; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: The Mammography Quality Standards Act Final May 5, 1999 Do Do Regulations Preparing for MQSA Inspections; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: The Mammography Quality Standards Act Final March 23, 1999 Do Do Regulations Motion of Tube-Image Receptor Assembly; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance: The Mammography Quality Standards Act Final December 7, 1999 Do Do Regulations: Quality Assurance Documentation; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Notification: 510(k)-Regulatory Requirements August 1, 1995 Office of Health and Industry Programs Do for Medical Devices (FDA 95-4158) [available on disk] (OHIP)/Division of Small Manufacturers Assistance (DSMA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Labeling-Regulatory Requirements for Medical Devices (FDA September 1, 1989 Do Do 89-4203) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Classification Names for Medical Devices and In Vitro March 1, 1995 Do Do Diagnostic Products (FDA Pub No. 95-4246) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ An Introduction to Medical Device Regulations (FDA 92- January 1, 1992 Do Do 4222) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Comparison Chart: 1996 Quality System Reg vs. 1978 Good November 11, 1996 Do Do Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Glove Guidance Manual; FDA 99-4257; Draft August 30, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ In Vitro Diagnostic Devices: Guidance for the Preparation January 1, 1997 Do Do of 510(k) Submissions (FDA 97-4224) [available on disk] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Instructions for Completion of Medical Device July 1, 1997 Do Do Registration and Listing Forms FDA 2891, 2891a and 2892 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Investigational Device Exemptions [IDE] Manual (FDA 96- June 1, 1996 Do Do 4159) [available on disk] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Appeals and Complaints: A Guidance on February 19, 1998 Do Do Dispute Resolution; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Reporting for Manufacturers [available on March 1, 1997 Do Do disk] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Premarket Approval (PMA) Manual; Final January 1, 1998 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Requirements for Devices for the Handicapped August 1, 1987 Do Do (FDA 87-4221) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Small Business Guide to FDA (FDA 96-1092) January 1, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45492]] The FDA Export Reform and Enhancement Act of 1996/Export February 7, 2000 Do Do Certification Package including ``Instructions for Requests for Certificate to Foreign Governments''; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ U.S.-FDA-Regulation of Medical Devices; Background April 14, 1999 Do Do Information for International Officials (entire document available on disk); Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 510(k) Manual-Premarket Notification: 510(k)-Regulatory August 1, 1995 Do Do Requirements for Medical Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Export--Foreign Liaison (part of ``Exporting Medical December 2, 1998 Do Do Devices,'' February 25, 1999) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Exporting Medical Devices; Final February 25, 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Third Party Programs Under the Sectoral Annex on Medical January 6, 1999 Do Do Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA); Guidance for Staff, Industry, and Third Parties; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Implementation of Third Party Programs Under the FDA October 30, 1998 Do Do Modernization Act of 1997; Guidance for Staff, Industry, and Third Parties; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Quality Systems Manual: A Small Entity December 1, 1996 Do Do Compliance Guide ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Do It By Design--An Introduction to Human Factors in December 1, 1996 Office of Health and Industry Programs Do Medical Devices (OHIP)/Division of Device User Programs and Systems Analysis (DUPSA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Medical Device Patient Labeling; Guidance for March 3, 2000 Do Do Industry; Draft DUPSA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Device Use Safety: Incorporating Human Factors in Risk August 3, 1999 Do Do Management; Guidance For Industry and FDA Premarket and DUPSA Postmarket Review Staff; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Human Factors Points to Consider for IDE Devices; Draft January 17, 1997 Do Do DUPSA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Human Factors Principles for Medical Device Labeling September 1, 1993 Do Do DUPSA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Reporting for User Facilities April 1, 1996 Do Do DUPSA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Write it Right; Recommendations for Developing User August 1, 1993 Do Do Instruction Manuals for medical Devices Used in Home Health Care ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Perspectives on Clinical Studies for Medical Device Unknown Pre-1997 Office of Surveillance and Biometrics Do Submissions (Statistical) (OSB)/ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PMA Review Statistical Checklist Unknown Pre-1997 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Statistical Aspects of Submissions to FDA: A Medical June 1, 1984 Office of Surveillance and Biometrics Do Device Perspective (also includes an Appendix the (OSB)/Division of Biostatistics (DB) article ``Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions'' ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45493]] Amendment to Guidance on Discretionary Postmarket March 30, 1994 Office of Surveillance and Biometrics Do Surveillance on Pacemaker Leads; Final (OSB)/Issues Management Staff (IMS) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Procedures for Review of Postmarket February 19, 1998 Do Do Surveillance Submissions [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Procedures to Determine Application of February 19, 1998 Do Do Postmarket Surveillance Strategies [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ SMDA to FDAMA: Guidance on FDA's Transition Plan for November 2, 1998 Do Do Existing Postmarket Surveillance Protocols [FDAMA]; Guidance for Industry and FDA Staff; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance to Sponsors on the Development of a June 9, 1993 Do Do Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads); Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Testing of Metallic Plasma Sprayed Coatings on Orthopedic February 2, 2000 Office of Surveillance and Biometrics Do Implants to Support Reconsideration of Postmarket (OSB)/Division of Postmarket Surveillance Requirements; Guidance for Industry; Final Surveillance (DPS) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Common Problems: Baseline Reports and Medwatch Form 3500A January 1997 Office of Surveillance and Biometrics Do (OSB)/Division of Surveillance Systems (DSS) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Instructions for Completing FDA Form 3500A with Coding December 15, 1995 Do Do Manual for Form 3500A (MEDWATCH) (MDR) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Documents Access Information for National Technical May 10, 1996 Do Do Information Service (NTIS) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Internet List Server (listserv) Instruction sheet August 29, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MEDWATCH FDA Form 3500A For Use By User Facilities, June 1, 1993 Do Do Distributors and Manufacturers for Mandatory Reporting (MDR) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Reporting Guidance For Breast Implants--E1996002 August 7, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Addendum to the Instructions for Completing FDA Form June 9, 1999 Do Do 3500A with Coding Manual (MEDWATCH) (MDR) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Instructions for Completing Form 3417: Medical Device March 31, 1997 Do Do Reporting Baseline Report MDR] ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Summary Reporting Approval for Adverse Events; Letter to July 31, 1997 Do Do Manufacturers; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Guidance Document No. 1--IOL--E1996004 August 7, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Guidance Document No. 3-Needlestick & Blood Exposure-- August 9, 1996 Do Do E1996003 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ MDR Guidance Document: Remedial Action Exemption-- July 30, 1996 Do Do E1996001 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45494]] MDR Reporting Guidance for Date-Related Problems April 16, 1999 Do Do Including Y2K ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Reporting: An Overview; Final April 1, 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Variance from Manufacturer Report Number Format [MDR July 16, 1996 Do Do letter]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ A Primer on Medical Device Interactions with Magnetic February 7, 1997 Office of Science and Technology (OST) Do Resonance Imaging Systems; Draft ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Frequently Asked Questions on Recognition of Consensus December 21, 1998 Do Do Standards [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size Unknown pre-1997 Do Do Distribution ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on the Recognition and Use of Consensus February 19, 1998 Do Do Standards/Appendix A [FDAMA]; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ CDRH Standard Operating Procedures for the Identification August 6, 1999 Do Do and Evaluation of Candidate Consensus Standard for Recognition; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Devices Containing Materials Derived from Animal November 16, 1998 Do Do Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on FDA's Expectations of Medical Device May 15, 1998 Do Do Manufacturers Concerning the Year 2000 Date Problems; Final ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance on Immunotoxicity Testing; Final May 6, 1999 Office of Science and Technology (OST)/ Do Division of Life Sciences (DLS) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ V. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN) -------------------------------------------------------------------------------------------------------------------------------------------------------- How To Obtain A Hard Copy of The Name of Document Date of Issuance Grouped by Intended User or Document (Name and Address, Phone, Regulatory Activity Fax, E-Mail or Internet) -------------------------------------------------------------------------------------------------------------------------------------------------------- Compliance Policy Guides Manual 1998 FDA Regulated Industries National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB96- 920500 -------------------------------------------------------------------------------------------------------------------------------------------------------- Compliance Programs Guidance Manual 1995 FDA Regulated Industries National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB95- 915499 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Recall Policy 1995 FDA Regulated Industries Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Investigators' Operations Manual May 1996 FDA Regulated Industries National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB-95- 913399 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45495]] Regulatory Procedures Manual August 1995 FDA Regulated Industries National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB95- 265534 -------------------------------------------------------------------------------------------------------------------------------------------------------- Requirements of Laws and Regulations Enforced 1997 FDA Regulated Industries Superintendent of Documents, by the U.S. Food and Drug Administration Government Printing Office, ``Blue Book'' Washington, DC 20402 -------------------------------------------------------------------------------------------------------------------------------------------------------- Action Levels for Poisonous or Deleterious 1995 Food and Animal Feed Industries Industry Activities Staff (HFS-565), Substances in Human Food and Animal Feed Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, PB96-920500 -------------------------------------------------------------------------------------------------------------------------------------------------------- Pesticides Analytical Manual 1994 Food Industry National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, PB94- 911899 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Advisory for Deoxynivanol (DON) in September 16, 1993 Food and Animal Feed Industries Office of Plant & Dairy Foods & Finished Wheat Products Intended for Human Beverages, Food and Drug Consumption and in Grain and Grain By- Administration (HFS-306), 200 C St. Products for Animal Feed SW., Washington, DC 20204, 202-205- 4681 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA's Cosmetic Labeling Manual October 1991 Cosmetic Industry Food and Drug Administration, Office of Colors and Cosmetics (HFS-105), 200 C St. SW., Washington, DC 20204, 202-205-4493 -------------------------------------------------------------------------------------------------------------------------------------------------------- Statement of Policy: Foods Derived from New May 29, 1992 (57 FR 22984) Developers of New Plant Food Office of Premarket Approval, Food Plant Varieties: Notice Varieties and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 -------------------------------------------------------------------------------------------------------------------------------------------------------- A Food Labeling Guide May 1997 Food Industry Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 -------------------------------------------------------------------------------------------------------------------------------------------------------- Appendix I--Model Small Business Food June 1996 Food Industry Do Labeling Exemption Notice -------------------------------------------------------------------------------------------------------------------------------------------------------- Food Labeling: Questions and Answers August 1994 Food Industry Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Food Labeling: Questions and Answers: Volume February 1996 Food Industry Superintendent of Documents, II Government Printing Office, Washington, DC 20420, 202-512-1800 -------------------------------------------------------------------------------------------------------------------------------------------------------- Fair Packaging and Labeling Act Manual June 1978 Food Industry National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487- 4650, PB-83-222117 -------------------------------------------------------------------------------------------------------------------------------------------------------- Bacteriological Analytical Manual 7th Edition 1992 FDA Regulated Industries AOAC International, 481 N. Frederick Ave., Suite 500, Gaithersburg, MD, 20877-2417, 301- 924-7077 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Food Importer's Guide for Low-Acid Canned 1985 Food Industry Industry Activities Staff (HFS- and Acidified Foods 565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205- 5251 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45496]] Fabrication of Single Service Containers and 1995 States Milk Safety Branch (HFS-626), Closures for Milk and Milk Products Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20202, 202-205-9175 -------------------------------------------------------------------------------------------------------------------------------------------------------- Evaluation of Milk Laboratories 1995 States Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Methods of Making Sanitation Ratings Of Milk 1995 States Do Supplies -------------------------------------------------------------------------------------------------------------------------------------------------------- Dry Milk Ordinance 1995 States Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Procedures Governing the Cooperative State- 1995 Dairy Industry Do Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers -------------------------------------------------------------------------------------------------------------------------------------------------------- Frozen Dessert Processing Guidelines 1989 Dairy Industry Office of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175 -------------------------------------------------------------------------------------------------------------------------------------------------------- Pasteurized Milk Ordinance 1995 States Milk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition 200 C St. SW., Washington, DC 20204, 202-205-9175 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Nutrition Labeling Manual: A Guide for 1993 Food Industry Office of Nutritional Products, Developing and Using Databases Labeling, and Dietary Supplements, Food and Drug Administration (HFS- 800), 200 C St. SW., Washington, DC 20204, 202-205-4561 -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Determining Metric Equivalents October 1, 1993 Food Industry Do of Household Measures -------------------------------------------------------------------------------------------------------------------------------------------------------- List of Food Defect Action Levels (DALS) 1995 Food and Animal Feed Industries Industry Activities Staff (HFS- 565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205- 5251 -------------------------------------------------------------------------------------------------------------------------------------------------------- Action Levels for Poisonous or Deleterious 1995 Food and Animal Do Substances in Human Food and Feed (Also Found in CPG's) -------------------------------------------------------------------------------------------------------------------------------------------------------- 1997 FDA Food Code 1997 States National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487- 4650 -------------------------------------------------------------------------------------------------------------------------------------------------------- Seafood List 1993 Seafood Industry Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202-512-1800 -------------------------------------------------------------------------------------------------------------------------------------------------------- Manual of Operations National Shellfish 1992 States Office of Seafood, Office of Seafood Sanitation (HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150 -------------------------------------------------------------------------------------------------------------------------------------------------------- Fish and Fisheries Products Hazards and 1996 Seafood Industry Do Controls Guide -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45497]] Guidance for Submitting Requests under 21 CFR 1996 Food Packaging Industry, Office of Premarket Approval, Food 170.39, Threshold of Regulation for and Drug Administration (HFS-200), Substances Used in Food Articles 200 C St. SW., Washington, DC 20204, 202-418-3100 -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for the Preparation of Petition 1996 Food Ingredient or Packaging Do Submissions Industry -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for Approval of Color Additives in 1996 Color or Contact Lens Industry Do Contact Lenses Intended as Colors -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Recommendations for Submission of February 1993 Color Additives Industry Do Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics Use -------------------------------------------------------------------------------------------------------------------------------------------------------- Points to Consider for the Use of Recycled December 1992 Food Packaging Industry Do Plastics in Food Packaging: Chemistry Considerations -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for Submission of Chemical May 1993 Food Packaging Industry Do and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- Recommendations for Chemistry Data for June 1995 Food Packaging Industry Do Indirect Food Additive Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- Enzyme Preparations: Chemistry January 1993 Food Enzyme Industry Do Recommendations for Food Additive and GRAS Affirmation Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimating Exposure to Direct Food Additive September 1995 Food and Food Ingredient Industry Do and Chemical Contaminants in the Diet -------------------------------------------------------------------------------------------------------------------------------------------------------- Toxicological Principles for the Safety 1982 Petitioners for Food or Color Do Assessment of Direct Food Additives and Additives Color Additives Used in Food (also known as Redbook I) -------------------------------------------------------------------------------------------------------------------------------------------------------- Environmental Assessment Technical Handbook March 1987 Petitioners for Food or Color National Technical Inion Service Additives (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, Pub. No. PB87175345-AS, Ab-01 -------------------------------------------------------------------------------------------------------------------------------------------------------- Color Additive Petitions Information and 1996 Petitioners for Color Additives Office of Premarket Approval, Food Guidance and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 -------------------------------------------------------------------------------------------------------------------------------------------------------- Toxological Testing of Food Additives 1983 Petitioners for Food or Color Office of Premarket Approval, Food Additives and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100 -------------------------------------------------------------------------------------------------------------------------------------------------------- List of Products for Each Product Category October 8, 1992 Food Industry Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 -------------------------------------------------------------------------------------------------------------------------------------------------------- Label Declaration of Allergenic Substances in June 10, 1996 Food Industry Do Foods; Notice to Manufacturers -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance on Labeling of Foods that Need February 24, 1997 (62 FR Food Industry Do Refrigeration by Consumers 8248) -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45498]] Guidelines Concerning Notification and 1985 Infant Formula Manufacturers Do Testing of Infant Formula -------------------------------------------------------------------------------------------------------------------------------------------------------- Clinical Testing of Infant Formulas with 1988 Infant Formula Manufacturers Do Respect to Nutritional Suitability for Term Infants -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for the Evaluation of the Safety 1988 Infant Formula Manufacturers Do and Suitability of New Infant Formulas for Feeding Infants with Allergic Diseases -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for the Evaluation of the Safety 1990 Infant Formula Manufacturers Do and Suitability of Infant Formulas for Feeding Infants with Allergic Diseases -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidelines for the Clinical Evaluation of New 1987 Infant Formula Manufacturers Do Products Used in the Dietary Management of Infants, Children and Pregnant Women with Metabolic Disorders -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Document for Arsenic (Trace Elements January 1993 States Office of Seafood, Food and Drug in Seafood) Administration (HFS-400), 200 C St. SW., Washington, DC 20204, 202-418- 3150, Internet: FDA Home Page Http:/ /vm.cfsan.fda.gov/list.html -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Document for Cadmium (Trace Elements January 1993 States Do in Seafood) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Document for Chromium (Trace January 1993 States Do Elements in Seafood) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Document for Lead (Trace Elements in August 1993 States Do Seafood) -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance Document for Nickel (Trace Elements January 1993 States Do in Seafood) -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA's Policy for Foods Developed by 1995 Food Industry Do Biotechnology -------------------------------------------------------------------------------------------------------------------------------------------------------- Bovine Spongiform Encephalopathy (BSE) In 1997 Food Industry Office of Plant and Dairy Foods and Products for Human Use Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175, Internet: FDA Home Page Http://www.fda.gov/opacom/ morechoices/industry/guidance/ gelguide.htm -------------------------------------------------------------------------------------------------------------------------------------------------------- Interim Guidance on the Voluntary Labeling of February 1994 Regulated Industry Office of Nutritional Products, Milk and Milk Products that have not been Labeling, and Dietary Supplements treated with Recombinant Bovine Somatropin (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168 -------------------------------------------------------------------------------------------------------------------------------------------------------- Shellfish Sanitation Model Ordinance 1995 States Shellfish Program Implementation Branch, Division of Cooperative Programs Office of Field Programs (HFS-628), 200 C St. SW., Washington, DC 20204, 202-205-8137 -------------------------------------------------------------------------------------------------------------------------------------------------------- Guide to Minimize Microbial Hazards for Fresh 1998 Farmers and Food Packers Lou Carson, Food Safety Initiative Fruits and Vegetables (HFS-3), FDA-CFSAN, 200 C St. SW., Washington, DC 20204 or jsaltsman@bangate.fda.gov -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45499]] Iron-Containing Supplements and Drugs: Label 1997 Dietary Supplement Manufacturers: Office of Nutritional Products, Warning and Unit Dose Packaging; Small Small Entities Labeling, and Dietary Supplements Entity Compliance Guide (HFS-450), FDA-CFSAN, 200 C. St. SW., Washington, DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Partial List of Enzyme Preparations That are 1998 FDA Regulated Industry Do Used in Foods -------------------------------------------------------------------------------------------------------------------------------------------------------- Partial List of Microorganisms and Microbial- 1998 FDA Regulated Industry Office of Premarket Approval (HFS- Derived Ingredients That Are Used in Food 200), FDA-CFSAN, 200 C St. SW., Washington, DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Fish and Fishery Products Hazards and January 1998 FDA Regulated Industry Office of Seafood (HFS-400), FDA- Controls Guide, 2nd Edition CFSAN, 200 C St. SW., Washington DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- HACCP Regulations for Fish and Fishery 1998 FDA Regulated Industry Do Products: Questions and Answers -------------------------------------------------------------------------------------------------------------------------------------------------------- Notification of a Health Claim or Nutrient 1998 FDA Regulated Industry Office of Nutritional Products, Content Claim Based on an Authoritative Labeling, and Dietary Supplements Statement of a Scientific Body (HFS-150), 200 C St. SW., Washington, DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Small Business Juice Labeling: Questions and 1998 Small Business Office of Nutritional Products, Answers Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204, Geraldine June, 202-205-5099 -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA Nutrition Labeling Manual, A Guide for March 1998 FDA Regulated Industry Office of Nutritional Products, Developing and Using Data Bases Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- HACCP Regulation for Fish and Fishery January 1999 Seafood Processors Office of Seafood, CFSAN/FDA (HFS- Products: Questions and Answers, Issue 400), 200 C St. SW., Washington, DC Three, Revised January 1999 20204, Ellen Nesheim, 202-418-3150 -------------------------------------------------------------------------------------------------------------------------------------------------------- Foods--Adulteration Involving Hard or Sharp February 1999 FDA Field Offices Office of Plant and Dairy Foods and Foreign Objects (CPG) Beverages (HFS-300), 200 C. St. SW., Washington, DC 20204 -------------------------------------------------------------------------------------------------------------------------------------------------------- Food Additive Petition Expedited Review January 1999 Guidance for Industry and Center for Robert L. Martin (HFS-215), OPA/ Food Safety and Applied Nutrition CFSAN/FDA, 200 C St. SW., Staff Washington, DC 20204, 202-418-3074, premarkt@cfsan.fda.gov OR http:// vm.cfsan.fda.gov/>dms/ opa-expe.html -------------------------------------------------------------------------------------------------------------------------------------------------------- Use of Antibiotic Resistance Marker Genes in September 1998 Guidance for Industry Nega Beru (HFS-206), OPA/CFSAN/FDA, Transgenic Plants 200 C. St. SW., Washington, DC 20204, 202-418-3097, premarkt@cfsan.fda.gov OR http:// vm.cfsan.fda.gov//dms/ opa- armg.html -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance: Channels of Trade Policy for June 2000 Regulated Industry Office of Plant and Dairy Foods and Commodities with Methyl Parathion Residues Beverages, Center for Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St. SW., Washington, DC 20204, http://vm.cfsan.fda.gov/dms -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45500]] Draft Guidance: Fumonisin Levels in Human June 2000 Regulated Industry Do Foods and Animal Feeds -------------------------------------------------------------------------------------------------------------------------------------------------------- Statement of Identity, Nutrition Labeling, January 1999 Small Business Entities Industry Activities Staff (HFS-565), and Ingredient Labeling of Dietary Center for Food Safety and Applied Supplements Small Entity Compliance Guide Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251 -------------------------------------------------------------------------------------------------------------------------------------------------------- Significant Scientific Agreement in the December 1999 Regulated Industry, Office of Nutritional Products, Review of Health Claims for Conventional Labeling, and Dietary Supplements, Foods and Dietary Supplements (December Center For Food Safety and Applied 1999) Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561 -------------------------------------------------------------------------------------------------------------------------------------------------------- Antimicrobial Food Additives July 1999 Regulated Industry Office of Premarket Approval (HFS- 200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418- 3100 -------------------------------------------------------------------------------------------------------------------------------------------------------- Preparation of Premarket Notifications for November 1999 Regulated Industry Do Food Contact Substances: Chemistry Recommendations -------------------------------------------------------------------------------------------------------------------------------------------------------- Preparation of Premarket Notifications for November 1999 Regulated Industry Do Food Contact Substances: Toxicology Recommendations -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidance for Small Businesses: Submission of October 1999 Small Business Entities Division of Market Studies (HFS- Comments for CFSAN Rulemaking 726), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, 202-401-4590 -------------------------------------------------------------------------------------------------------------------------------------------------------- Warning and Notice Statement: Labeling of September 1998 Regulated Industry Office of Nutritional Products, Juice Products Small Entity Compliance Guide Labeling, and Dietary Supplements, Center For Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561 -------------------------------------------------------------------------------------------------------------------------------------------------------- Reducing Microbial Food Safety Hazards for October 1999 Regulated Industry Office of Plant and Dairy Foods and Sprouted Seeds Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202- 205-4064 -------------------------------------------------------------------------------------------------------------------------------------------------------- Seafood HACCP Transition Policy December 1999 Regulated Industry Office of Seafood (HFS-400), 200 C St. SW., Washington DC 20204, 202- 205-3150 -------------------------------------------------------------------------------------------------------------------------------------------------------- VI. Guidance Documents Issued by the Center for Veterinary Medicine (CVM) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Grouped by Intended User or How to Obtain a Hard Copy of the Document (Name and Name of Document Date of Issuance Regulatory Activity Address, Phone, FAX, E-mail or Internet) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 3--General Principles for Evaluating the Safety July 1994 Animal Drug Industry Internet via: http://www.fda.gov/cvm or Communications of Compounds Used in Food-Producing Animals Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, FAX 301-594-1831 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 4--Guidelines for Efficacy Studies for Systemic Do Do Sustained Release Sulfonamide Boluses for Cattle ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45501]] Guideline 5--Stability Guidelines December 1990 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 6--Guidelines for Submitting NADA's for Generic Do Do Drugs Reviewed by NAS/NRC ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 9--Preclearance Guidelines for Production Drugs October 1975 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 10--Amendment of Section II (G)(1)(b)(4) of the October 1975 Do Do Preclearance Guidelines ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 13--Guidelines for Evaluation of Effectiveness of January 1985 Do Do New Animal Drugs for Use in Free-Choice Feeds ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 14--Guideline and Format for Reporting the Do Do Details of Clinical Trials Using An Investigational New Animal Drug in FOOD Producing Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 15--Guideline and Format for Reporting the February 1977 Do Do Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 16--FOI Summary Guideline May 1985 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 18--Antibacterial Drugs in Animal Feeds: Human Do Do Health Safety Criteria ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 19--Antibacterial Drugs in Animal Feeds: Animal Do Do Health Safety Criteria ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 20--Antibacterial Drugs in Animal Feeds: Do Do Antibacterial Effectiveness Criteria ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 22--Guideline Labeling of Arecoline Base Drugs Do Do Intended for Animal Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 23--Medicated Free Choice Feeds--Manufacturing July 1985 Do Do Control ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 24--Guidelines for Drug Combinations for Use in October 1983 Do Do Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 25--Guidelines for the Efficacy Evaluation of January 1979 Do Do Equine Anthelmintics ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 29--Guidelines for the Effectiveness Evaluation September 1980 Do Do of Swine Anthelmintics ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 31-- Guidelines for the Evaluation of Bovine July 1981 Do Do Anthelmintics ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 33--Target Animal Safety Guidelines for New June 1989 Do Do Animal Drugs ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 35--Bioequivalence Guideline--Final 1996 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 36--Guidelines for Efficacy Evaluation of Canine/ July 1985 Do Do Feline Anthelmintics ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 37--Guidelines for Evaluation of Effectiveness of March 1984 Do Do New Animal Drugs for Use in Poultry Feed for Pigmentation ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 38--Guideline for Effectiveness Evaluation of August 1984 Do Do Topical/Otic Animal Drugs ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 40--Draft Guideline for the Evaluation of the April 1992 Do Do Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45502]] Guideline 41--Draft Guideline: Formatting, Assembling, and June 1992 Do Do Submitting New Animal Drug Applications ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 42--Animal Drug Manufacturing Guidelines, 1994 1994 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 43--Guidance on Generic Animal Drug Products October 1995 Do Do Containing Fermentation-Derived Drug Substances ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 45--Guideline for Uniform Labeling of Drugs for August 1993 Do Do Dairy and Beef Cattle ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 48--Guidance for Industry for the Submission of November 1994 Do Do Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 49--Guidance Document for Target Animal Safety April 1996 Do Do and Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 50--Draft Guideline for Target Animal and Human February 1993 Do Do Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 52--Guidance--Microbiological Testing of January 1996 Do Do Antimicrobial Drug Residues in Food ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 53--Guideline for the Evaluation of the Utility May 1994 Do Do of Food Additives in Diets Fed to Aquatic Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 54--Draft Guideline for Utility Studies for Anti- June 1994 Do Do Salmonella Chemical Food Additives in Animal Feeds ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 55--Supportive Data for Cat Food Labels Bearing June 1994 Do Do ``Reduces Urinary pH Claims: Guideline in Protocol Development'' ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 56--Protocol Development Guideline for Clinical November 1994 Do Do Effectiveness and Target Animal Safety Trials ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 57--Master Files--Guidance for Industry for the July 1995 Do Do Preparation and Submission of Veterinary Master Files ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 58--Guidance for Industry for Good Target Animal May 1997 Do Do Study Practices: Clinical Investigators and Monitors ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 59--Guidance for Industry: Submitting a Notice of January 1999 Do Do Claimed Investigational Exemption in Electronic Format to CVM via E-Mail ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance 61--Guidance for Industry--FDA Approval of Animal January 1999 Do Do Drugs for Minor Uses and for Minor Species ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 62--Guidance for Industry--Consumer-Directed August 1997 Do Do Broadcast Advertisements ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 63--Guidance for Industry--Validation of December 1997 Do Do Analytical Procedures: Definition and Terminology--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45503]] Guideline 64--Guidance for Industry--Validation of December 1997 Do Do Analytical Procedures: Methodology--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 65--Guidance for Industry--Industry-Supported November 1997 Do Do Scientific and Educational Activities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 66--Guidance for Industry-- Professional Flexible January 1998 Do Do Labeling of Antimicrobial Drugs--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 67--Guidance for Industry--Small Entities February 1998 Do Do Compliance Guide for Renderers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 68--Guidance for Industry--Small Entities February 1998 Do Do Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 69--Guidance for Industry--Small Entities February 1998 Do Do Compliance Guide for Feeders of Ruminant Animals With On- Farm Feed Mixing Operations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 70--Guidance for Industry--Small Entities February 1998 Do Do Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 71--Guidance for Industry--Use of Human Chorionic April 1998 Do Do Gonadotropic (HCG) as a Spawning Aid for Fish ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 72--Guidance for Industry--GMP's for Medicated May 1998 Do Do Feed Manufacturers Not Required to Register and Be Licensed With FDA ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 73--Draft Guidance for Industry--Stability July 1998 Do Do Testing of New Animal Drug Substances and Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 74--Draft Guidance for Industry--Stability July 1998 Do Do Testing for New Dosage Forms of New Animal Drugs ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 75--Guidance for Industry--Stability Testing: July 1998 Do Do Photostability Testing of New Animal Drug Substances and Products: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 76--Guidance for Industry--Questions and Answers-- September 1998 Do Do BSE Feed Regulation ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 77--Guidance for Industry--Interpretation of On- September 1998 Do Do Farm Feed Manufacturing and Mixing Operations--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guideline 78--Guidance for Industry--Evaluation of the December 1999 Do Do Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food- Producing Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Chemistry, Manufacturing and June 1999 Do Do Controls Changes to an Approved NADA or ANADA: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance for Industry: Good Clinical Practices July 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45504]] Guidance for Industry: Efficacy of Anthelmintics: General July 1999 Do Do Recommendations: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Stability Testing for Medicated July 1999 Do Do Premixes Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Impurities in New Veterinary Drug July 1999 Do Do Substances Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Impurities in New Veterinary Medical July 1999 Do Do Products Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Efficacy of Anthelmintics: Specific July 1999 Do Do Recommendations for Bovines: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Efficacy of Anthelmintics: Specific July 1999 Do Do Recommendations for Ovines: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--Validation of Analytical Procedures: July 1999 Do Do Definition and Terminology ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--Validation of Analytical Procedures: July 1999 Do Do Methodology: Final Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Efficacy of Anthelmintics: Specific July 1999 Do Do Recommendations for Caprines: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Manufacture and Distribution of August 1999 Do Do Unapproved Piperazine Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Possible Dioxin/PCB Contamination of August 1999 Do Do Drug and Biological Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--Consumer-Directed Broadcast August 1999 Do Do Advertisements: Final Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Stability Testing of New Veterinary September 1999 Do Do Dosage Forms VICH GL4: Final Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Stability Testing of New Veterinary September 1999 Do Do Drug Substances and Medicinal Products VICH GL3: Final Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Environmental Impact Assessments September 1999 Do Do (EIA's) for Veterinary Medicinal Products (VMP's)--Phase I: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Quality of Biotechnological Products September 1999 Do Do in the Veterinary Field: Stability Testing of Biotechnological/Biological Products VICH GL 17: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Impurities: Residual Solvents VICH September 1999 Do Do GL 18: Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--Content and Format of Effectiveness September 1999 Do Do and Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Non-Food Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Stability Testing: Photostability September 1999 Do Do Testing of New Veterinary Drug Substances and Medicinal Products: Final Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45505]] Computerized Systems Used in Clinical Trials October 1999 Do Do ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Dioxin in Anti-Caking Agents Used in Animal Feed and Feed October 1999 Do Do Ingredients ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry--Evaluation of the Human Health December 1999 Do Do Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Development of Supplemental January 2000 Do Do Applications for Approved New Animal Drugs--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Stability Testing for Medicated March 2000 Do Do Premixes Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: The Use of Published Literature in April 11, 2000 Do Do Support of New Animal Drug Approval--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Dioxin In Anti-Caking Agents Used In Revised April 12, 2000 Do Do Animal Feed And Feed Ingredients ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidance for Industry: Fumonisin Levels in Human Foods and June 6, 2000 Do Do Animal Feeds--Draft Guidance ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ VII. Guidance Documents Issued by the Office of Policy (OP) -------------------------------------------------------------------------------------------------------------------------------------------------------- How To Obtain A Hard Copy of The Name of Document Date of Issuance Grouped by Intended User or Document (Name and Address, Phone, Regulatory Activity FAX, E-mail, or Internet) -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA's Development, Issuance, and Use of Guidance February 27, 1997 FDA Personnel and Regulated Internet via www.fda.gov/opacom/ Documents Industry morechoices/moreindu.html or Office of Policy (301-827-3360) -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry; Exports and Imports June 12, 1998 Regulated Industry Internet via www.fda.gov/opacom/ under the FDA Export Reform and Enhancement Act of fedregister/frexport.html 1996 -------------------------------------------------------------------------------------------------------------------------------------------------------- Direct Final Rule Guidance November 21, 1997 FDA Personnel Internet via www.fda.gov/opacom/ morechoices/industry/guidedc.htm or Carol Kimbrough (301-827-3480) -------------------------------------------------------------------------------------------------------------------------------------------------------- Industry Supported Scientific and Educational December 3, 1997 Regulated Industry Internet via www.fda.gov/cder/ Activities guidance/index.htm or Office of Policy (301-827-3360) -------------------------------------------------------------------------------------------------------------------------------------------------------- Draft Guidance of Broadcast Advertisements February 1997 Do Do -------------------------------------------------------------------------------------------------------------------------------------------------------- Small Entities Compliance Guide On: Regulations to February 1997 Do Internet via www.fda.gov/opacom/ Restrict the Sale and Distribution of Cigarettes and campaigns/tobacco/tobret.htm or 1- Smokeless Tobacco in Order to Protect Children and 888-FDA-4KIDS Adolescents (21 CFR Part 897) -------------------------------------------------------------------------------------------------------------------------------------------------------- Children & Tobacco--Frequently Asked Questions about July 1997 Do Do the new regulations (DRAFT) -------------------------------------------------------------------------------------------------------------------------------------------------------- Children & Tobacco--A Retailer's Guide to the New October 1997 Do Do Federal Regulations -------------------------------------------------------------------------------------------------------------------------------------------------------- Children & Tobacco--A Guide to the New Federal October 1997 Do Do Regulations -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 45506]] FDA's Standards Policy October 1995 FDA Personnel and Regulated 60 FR 53078, October 11, 1995 or Industry Office of Policy (301-827-3360) -------------------------------------------------------------------------------------------------------------------------------------------------------- VIII. Guidance Documents Issued by the Office of Regulatory Affairs (ORA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Grouped by Intended User or How To Obtain A Hard Copy of The Document (Name and Address, Name of Document Date of Issuance Regulatory Activity Phone, FAX, E-mail, or Internet) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guides Manual August 1996 FDA Staff Personnel National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-915499) or via Internet www.fda.gov/ora/compliance__ref/cpg/cpgtc.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide-DRAFT Commercialization of In January 5, 1998 Do Do--Internet at www.fda.gov/cdrh/comp/ivddrfg.html Vitro Diagnostic Devices (IVD's) Labeled for Research Use Only or Investigational Use Only ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide 675.400 (CPG 7126.24) REVISION November 13, 1998 Do Do--Internet at www.fda.gov/ora/compliance__ref/cpg/cpgvet/ Rendered Animal Feed Ingredients cpg675.400.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide DRAFT Distributor Medical Device August 28, 1997 FDA Staff Personnel and Regulated Do--Internet at www.fda.gov/ora/compliance__ref/cpg__mdr3.txt Reporting Industry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 5, Sec. 555.425, NEW: March 23, 1999 FDA Staff Personnel Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/cpgfod/ Foods Adulteration Involving Hard or Sharp Foreign cpg555-425.htm Objects ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 1, Sec.160.800, NEW:Year April 26, 1999 Do Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/ 2000 (Y2K) Computer Compliance cpggenl/cpt160.800.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 1, Sec. 140.100, REVISION/ April 26, 1999 Do Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/cpgfod/ DRAFT: Regulatory Policy on the Disposition of draftrev-cpg715313.htm Publications That Constitute Labeling (CPG 7153.13) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 1, Sec. 160.850: NEW, May 13, 1999 Do Do--Internet at htpp://www.fda.gov/ora/compliance__ref/cpg/ Enforcement Policy: 21 CFR Part 11; Electronic Records; cpggenl/cpg160-180.htm Electronic Signatures (CPG 7153.17) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 2, Sec. 230.140, NEW, July 9, 1999 Do Do--Internet at http://www.fda.gov/ora/compliance__ref/ Evaluation and Processing of Post Donation Information default.htm Reports ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 2, Sec. 252.110, NEW: March 6, 2000 Do Do--Internet at http://www.fda.gov/ora/compliance__ref/cpgbio/ Volume Limits for Automated Collection of Source Plasma cpg252.110.htm ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED: March 22, 2000 Do Do--Internet at http://www.fda.gov/ora/cmpliance__ref/cpg/cpgbio/ Deferral of Source Plasma Donors Due to Red Cell Loss cpg257.100.htm During Collection of Source Plasma by Automated Plasmapheresis ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Policy Guide, Chapter 1, Sec. 110.100: REVISED: April 14, 2000 Do Do--Internet at http://www.fda.gov/ora/compliance__ref/cpg/ Certificates for Export cpggenl/cpg110-100.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Medical Device Warning Letter Pilot March 8, 1999 FDA Staff Personnel and Regulated Do--Internet at http://www.fda.gov/ohrms/Dockets/98fr/030899e.pdf Industry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45507]] Draft Guidance Policy Statement: Draft Civil Money Penalty May 18, 1999 Do Do--Internet at http://www.fda.gov/ohrms/Dockets/98fr/051899.txt Reduction Policy for Small Entities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Glossary of Computerized System and Software Development August 1995 Do National Technical Information Service (NTIS), 5285 Port Royal Terminology Rd., Springfield, VA 22161 (Order No. PB96-127352) or via Internet www.fda.gov/ora/inspect__ref/igs/iglist.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guidelines for Entry Review of Radiation-Emitting March 12, 1999 FDA Staff Personnel Division of Import Operations and Policy (HFC-170), Office of Electronic Devices Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Import Alerts Continuous Do FDA/Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857 or via Internetwww.fda.gov/ora/fiars/ ora__import__alerts.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Investigations Operations Manual March 2000 Do Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 2000 Edition is not yet available on Internet. 1999 Edition is available on Internet at http:// www.fda.gov/ora/inspect__ref/iom/iomtc.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Investigations Operations Manual, REVISION: Chapter 4, July 1998 Do Do Sampling ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Investigations Operations Manual, REVISION: Chapter 5, July 1998 Do Do Establishment Inspections ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Memorandum: ORA Investigational Strategy on Gamma- May 15, 2000 Do Do--Not available on Internet Butyrolactone (GBL) and Related Products ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Laboratory Procedures Manual June 1994 Do Division of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, ATTN: Donna Porter or via Internet www.fda.gov/ora/ science__ref/lpm/lpmtc.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Laboratory Procedures Manual, Chapter X, NEW: Method May 1999 Do Do--Not available on Internet Validation Samples ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual August 1997 Do National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB97-196182) or via Internet www.fda.gov/ora/compliance__ref/rpm/rpmtc.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE/New Subchapter/ March 1998 Do Division of Compliance Policy (HFC-230), Office of Enforcement, Application Integrity Policy Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet www.fda.gov/ora/ compliance__ref/rpm/rpmtc.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE Subchapter/Warning March 1998 Do Do Letters ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ April 1998 Do Do Import Procedures ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual; UPDATE/REVISION Subchapter/ April 1998 Do Do Priority Enforcement Strategy for Problem Importers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45508]] Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ April 1998 Do Do Import Procedures ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ April 1998 Do Do Notice of Sampling ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE/NEW Subchapter/ May 1998 Do Do Granting and Denying Transportation and Exportation (T&E) Entries ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ June 1998 Do Do--Internet at www.fda.gov/ora/compliance__ref/rpm__new2/ Seizure ch6.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: UPDATE/REVISION Subchapter/ June 1998 Do Do--Internet at www.fda.gov/ora/compliance__ref/rpm__new2/ Supervisory Charges ch9chgs.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual: NEW Subchapter/Civil July 1998 Do Do--Internet at www.fda.gov/ora/compliance__ref/ch6civpen.html Penalties--Electronic Product Radiation Control ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Regulatory Procedures Manual, UPDATE/REVISION: Chapter 4, March 21, 2000 Do Do Internet at http://www.fda.gov/ora/compliance__ref/rpm__new2/ Subchapter/Warning Letters ch4.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Bulk Pharmaceutical Chemicals May 1994 Do National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-127154) or via Internet www.fda.gov/ora/inspect__ref/igs/iglist.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Pharmaceutical Quality Control July 1993 Do Do--(NTIS Order No. PB96-127279) Laboratories ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Microbiological Pharmaceutical July 1993 Do Do--(NTIS Order No. PB96-127287) Quality Control Laboratories ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Validation of Cleaning Processes July 1993 Do Do--(NTIS Order No. PB96-127246) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Lyophilization of Parenterals July 1993 Do Do--(NTIS Order No. PB96-127253) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of High Purity Water Systems July 1993 Do Do--(NTIS Order No. PB96-127261) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Dosage Form Drug Manufacturers- October 1993 Do Do--(NTIS Order No. PB96-127212) CGMPs ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Oral Solid Dosage Forms Pre/Post January 1994 Do Do--(NTIS Order No. PB96-127345) Approval Issues for Development and Validation ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Topical Drug Products July 1994 Do Do--(NTIS Order No. PB96-127394) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Sterile Drug Substance July 1994 Do Do--(NTIS Order No. PB96-127295) Manufacturers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Oral Solutions and Suspensions August 1994 Do Do--(NTIS Order No. PB96-127147) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Nutritional Labeling and Education February 1995 Do Do--(NTIS Order No. PB96-127378) Act (NLEA) Requirements ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Interstate Carriers and Support April 1995 Do Do--(NTIS Order No. PB96-127386) Facilities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45509]] Guide to Inspections of Dairy Product Manufacturers April 1995 Do Do--(NTIS Order No. PB96-127329) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Miscellaneous Foods Vol. I May 1995 Do Do--(NTIS Order No. PB96-127220) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Miscellaneous Foods Vol. II September 1996 Do Do--(NTIS Order No. PB97-196133) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Low Acid Canned Foods November 1996 Do Do--(NTIS Order No. PB97-196141) Manufacturers, Part 1-Administrative Procedures/Scheduled Processes ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Low Acid Canned Foods April 1997 Do Do--(NTIS Order No. PB97-196158) Manufacturers, Part 2- Processes/Procedures ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Cosmetic Product Manufacturers February 1995 Do Do--(NTIS Order No. PB96-127238) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Blood Banks September 1994 Do Do--(NTIS Order No. PB96-127303) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Source Plasma Establishments December 1994 Do Do--(NTIS Order No. PB96-127360) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Infectious Disease Marker Testing June 1996 Do Do--(NTIS Order No. PB96-199476) Facilities ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Biotechnology Inspections Guide November 1991 Do Do--(NTIS Order No. PB96-127402) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Computerized Systems in Drug February 1983 Do Do--(NTIS Order No. PB96-127337) Processing ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Foreign Medical Device September 1995 Do Do--(NTIS Order No. PB96-127311) Manufacturers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Foreign Pharmaceutical May 1996 Do Do--(NTIS Order No. PB96-199468) Manufacturers ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Mammography Quality Standards Act (MQSA) Auditors Guide January 1998 Do Do--(NTIS Order No. PB98-127178) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Electromagnetic Compatibility December 1997 Do Do--(NTIS Order No. PB98-127152) Aspects of Medical Device Quality Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Grain Product Manufacturers March 1998 Do Division of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Bioresearch Monitoring Inspections of In Vitro February 1998 Do Do Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Viral Clearance Processes for March 1998 Do Do Plasma Derivatives ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Traceback of Fresh Fruits and Vegetables August 1998 Do Do Implicated in Epidemiological Investigations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Computerized Systems in the Food August 1998 Do Do--Internet at www.fda.gov/ora/inspect__ref/igf/iglist.html Processing Industry ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to International Inspections and Travel, REVISION July 1999 Do Do Revision not available on Internet (Formerly: FDA/ORA International Inspection Manual and Travel Guide) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Guide to Inspections of Quality Systems August 1999 Do Do--Internet at http://www.fda.gov/ora/inspect__ref/igs/qsit/ QSITGUIDE.PDF ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ [[Page 45510]] Guideline for the Monitoring of Clinical Investigators January 1988 FDA Regulated Industry Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Computerized Systems Used in Clinical Trials April 1999 Do Do--Internet at http://www.fda.gov/ora/compliance__ref/bimo/ ffinalcct.htm ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Draft Guidance for Institutional Review Boards, Clinical March 30, 2000 Do Do--Internet at http;//www.fda.gov/ora/compliance__ref/bimo__err- Investigators, and Sponsors: Exception from Informed guide.htm Consent Requirements for Emergency Research ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Program 7348.808: Bioresearch Monitoring; Good Revised August 17, 1998 FDA Staff Personnel Do--Internet http://www.fda.gov/ora/compliance__ref/bimo/ Laboratory Practices (Nonclinical) default.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Program 7348.810: Sponsors, Contract Research Revised October 30, 1998 Do Do Organizations and Monitors ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Program 7348.811: Bioresearch Monitoring; Revised September 2, 1998 Do Do Clinical Investigations ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Food Laboratory Practice Program (Nonclinical October 1, 1991 Do Division of Compliance Policy (HFC-230), Office of Enforcement, Laboratories) 7348.808A; EPA Data Audit Inspections Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Compliance Program 7348.809; Bioresearch Monitoring; August 18, 1994 Do Do Institutional Review Board ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Good Laboratory Practice Regulations Management Briefings August 1979 Do Do--Internet at www.fda.gov/ora/compliance__ref/bimo/default.html ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Dated: July 14, 2000. Margaret M. Dotzel, Associate Commissioner for Policy. [FR Doc. 00-18497 Filed 7-20-00; 8:45 am] BILLING CODE 4160-01-F