[Federal Register: June 10, 1999 (Volume 64, Number 111)] [Notices] [Page 31228-31280] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10jn99-101] ----------------------------------------------------------------------- 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. FDA committed to publishing this list in its February 1997 ``Good Guidance Practices'' (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. This list is intended to inform the public of the existence and availability of all current guidance documents. DATES: General comments on this list and on agency guidance documents are welcome 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. Information on where to obtain a single copy of listed guidance documents is provided for each agency Center individually in the specific Center's list of guidance documents. FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Office of Policy (HF-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 27, 1997 (62 FR 8961), FDA published a notice announcing its GGP's, which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. The agency adopted the GGP's to ensure public involvement in the development of guidance documents and to enhance public understanding of the availability, nature, and legal effect of such guidance. As part of FDA's effort to ensure meaningful interaction with the public regarding guidance documents, the agency 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comprehensive list of guidance documents and quarterly updates that list all guidance documents that were issued and withdrawn during that quarter, including ``Level 2'' guidance documents. 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, [[Page 31229]] FDA uses the principles of ``plain language'' set forth by the President when writing its guidance documents. The agency seeks public comment on the clarity of its guidances. The following comprehensive list of guidance documents represents all guidances currently in effect. This comprehensive list is maintained on the FDA World Wide Web home page. This list will be updated and published annually in the Federal Register. The guidance documents on this comprehensive list are organized by the issuing Center or Office within FDA, and are further grouped by the intended users or regulatory activities to which they pertain. Dates provided in the following list refer to the date of issuance or, where applicable, the date of last revision of the document. Document numbers are provided where available. II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity or Internet) ---------------------------------------------------------------------------------------------------------------- Requirements for Infrequent August 27, 1982 FDA regulated Office of Communication, Plasmapheresis Donors industry Training, and Manufacturers Assistance (HFM-40), 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: http://www.fda.gov/ cber Recommendations to Decrease the Risk March 24, 1983 Do Do of Transmitting AIDS from Plasma Donors Deferral of Blood Donors Who Have February 28, 1984 Do Do Received the Drug Accutane (isotretinoin/Roche); 13-cis-retinoic acid) Equivalent Methods for Compatibility December 14, 1984 Do Do Testing Plasma Derived from Therapeutic Plasma December 14, 1984 Do Do Exchange Reduction of the Maximum Platelet June 2, 1986 Do Do Storage Period to 5 Days in an Approved Container Deferral of Donors Who Have Received November 25, 1987 Do Do Human Pituitary-Derived Growth Hormone Recommendations for the Management of December 2, 1987 Do Do Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg) Extension of Dating Period for Storage December 4, 1987 Do Do of Red Blood Cells, Frozen To Licensed In-Vitro Diagnostic December 23, 1987 Do Do Manufacturers: 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 July 7, 1988 Do Do Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines Physician Substitutes August 15, 1988 Do Do To Licensed Manufacturers of Blood August 26, 1988 Do Do Grouping Reagents: Criteria for Exemption of Lot Release To Manufacturers of HTLV-I Antibody October 18, 1988 Do Do Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel I HTLV-1 Antibody Testing November 29, 1988 Do Do Use of Recombigen HIV-1 LA Test February 1, 1989 Do Do Guidance for Autologous Blood and March 15, 1989 Do Do Blood Components HTLV-I Antibody Testing July 6, 1989 Do Do Use of Recombigen HIV-1 Latex August 1, 1989 Do Do Agglutination (LA) Test Requirements for Computerization of September 8, 1989 Do Do Blood Establishments Abbott Laboratories' HIVAG-1 Test for October 4, 1989 Do Do HIV-1 Antigen(s) Not Recommended for Requirements for Computerization of Blood Establishments Autologous Blood Collection and February 12, 1990 Do Do Processing Procedures Use of Genetic Systems HIV-2 EIA June 21, 1990 Do Do Deficiencies Relating to the March 20, 1991 Do Do Manufacture of Blood and Blood Components [[Page 31230]] Responsibilities of Blood March 20, 1991 Do Do Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components Revision to October 26, 1989 Guideline April 17, 1991 Do Do for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers (High Risk Donors) FDA Recommendations Concerning Testing September 10, 1991 Do Do for Antibody to Hepatitis B Core Antigen (Anti-HBc) Disposition of Blood Products Intended September 11, 1991 Do Do for Autologous Use That Test Repeatedly Reactive for Anti-HCV Clarification of FDA Recommendations December 12, 1991 Do Do for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing Revised Recommendations for the April 23, 1992 Do Do Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products Use of Fluorognost HIV-1 April 23, 1992 Do Do Immunofluorescent Assay (IFA) Revised Recommendations for Testing April 23, 1992 Do Do Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) Exemptions to Permit Persons with a April 23, 1992 Do Do History of 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 July 21, 1992 Do Do Blood Donor Samples Nomenclature for Monoclonal Blood August 19, 1993 Do Do Grouping Reagents Volume Limits for Automated Collection November 4, 1992 Do Do of Source Plasma Revision of October 7, 1988 Memo December 16, 1992 Do Do Concerning Red Blood Cell Immunization Programs Recommendations Regarding License July 22, 1993 Do Do Amendments and Procedures for Gamma Irradiation of Blood Products Deferral of Blood and Plasma Donors July 28, 1993 Do Do Based on Medications Revised Recommendations for Testing August 19, 1993 Do Do Whole 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 Guidance Regarding Post Donation December 10, 1993 Do Do Information Reports Donor Suitability Related to December 22, 1993 Do Do Laboratory Testing for Viral Hepatitis and a History of Viral Hepatitis Recommendations for the Invalidation January 3, 1994 Do Do of Test Results When Using Licensed Viral Marker Assays to Screen Donors Recommendations for Deferral of Donors July 26, 1994 Do Do for Malaria Risk Use of and FDA Cleared or Approved August 5, 1994 Do Do Sterile Docking Device (STCD) in Blood Bank Practices (transmittal memo 8/12/94) (corrects 7/29/94 Memo) Recommendations to Users of Medical December 20, 1994 Do Do Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test Systems Timeframe for Licensing Irradiated February 3, 1995 Do Do Blood Products Revision of 8/27/82 FDA Memo: March 10, 1995 Do Do Requirements for Infrequent Plasmapheresis Donors To All Establishments Performing Red March 14, 1995 Do Do Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma [[Page 31231]] Recommendations for the Deferral of June 8, 1995 Do Do Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source Plasma Disposition of Products Derived from August 8, 1995 Do Do Donors Diagnosed with, or at Known High Risk for, Creutzfeldt-Jakob Disease Recommendations for Labeling and Use August 8, 1995 Do Do of Units 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 August 8, 1995 Do Do Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood Products Recommendations for Donor Screening August 8, 1995 Do Do with a Licensed Test for HIV-1 Antigen Guidance Concerning Conversion to FDA- November 13, 1995 Do Do Reviewed Software Products Donor Deferral Due to Red Blood Cell December 4, 1995 Do Do Loss During Collection of Source Plasma by Automated Plasmapheresis Additional Recommendations for Donor March 14, 1996 Do Do Screening With a Licensed Test for HIV-1 Antigen Additional Recommendations for Testing May 16, 1996 Do Do Whole Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) Recommendations and Licensure May 29, 1996 Do Do Requirements for Leukocyte-Reduced Blood Products 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) Interim Recommendations for Deferral December 11, 1996 Do Do of Donors at Increased Risk for HIV-1 Group O Infection Revised Precautionary Measures to December 11, 1996 Do Do Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products Interstate Shipment of Interferon for November 21, 1983 Do Do Investigational Use in Laboratory Research Animals or Tests in Vitro Alternatives to Lot Release July 20, 1993 Do Do Application of Current Statutory October 14, 1993 Do Do Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice Home Specimen Collection Kit Systems February 23, 1995 Do Do Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous Guidance Interim Definition and Elimination of December 8, 1995 Do Do Lot-by-Lot Release for Well- Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products Draft Public Health Service Guideline September 23, 1996 Do Do on Infectious Disease Issues in Xenotransplantation; Notice The Food and Drug Administration's February 27, 1997 Do Do Development, Issuance, and Use of Guidance Documents Preclearance of Promotional Labeling; March 5, 1997 Do Do Clarification Draft Guidance for Industry: June 18, 1997 Do Do Computerized Systems Used in Clinical Trials; Availability Recommended Methods for Short Ragweed November 1, 1985 Do Do Pollen Extracts Information Relevant to the August 23, 1989 Do Do Manufacture of Acellular Pertussis Vaccine Recommended Methods for Blood Grouping March 1, 1992 Do Do Reagents Evaluation [[Page 31232]] Recommended Methods for Evaluating March 1, 1992 Do Do Potency, Specificity and Reactivity of Anti-Human Globulin Methods of the Allergenic Products October 1, 1993 Do Do Testing Laboratory Guide to Inspections of Blood Banks, September 1, 1994 FDA personnel Do Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs Guide to Inspections of Infectious June 1, 1996 Do Do Disease Marker Testing Facilities Guide to Inspections of Source Plasma June 1, 1997 Do Do Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs) Notification Process for Transfusion October 7, 1997 FDA regulated Do Related Fatalities and Donation industry Related Deaths (revised telephone number) Submission Requirements for Requesting October 15, 1997 Do Do Certificates for Exporting Products to Foreign Countries CBER Refusal to File (RTF) Guidance July 12, 1993 Do Do for Product and Establishment License Applications OELPS, Advertising and Promotional August 1, 1994 Do Do Labeling Staff Procedural Guidance Document (Draft) Guidance on Alternatives to Lot October 27, 1994 Do Do Release for Licensed Biological Products Content and Format of Investigational November 1, 1995 Do Do New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products Computer Assisted Product License March 1, 1996 Do Do Application (CAPLA) Guidance Manual FDA Guidance Concerning Demonstration April 26, 1996 Do Do of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products Guidance for Industry--The Content and May 23, 1996 Do Do Format for Pediatric Use Supplements Guidance on Applications for Products May 24, 1996 Do Do Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of Reconstruction Guidance for Industry for the August 15, 1996 Do Do Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use Draft Guidance for Industry: September 20, 1996 Do Do Manufacture, Processing or Holding of Active Pharmaceutical Ingredients Draft Guidance for Industry; November 4, 1996 Do Do Submitting Application Archival Copies in Electronic Format Draft Guidance for Industry; November 4, 1996 Do Do Electronic Submission of Case Report Forms and Case Report Tabulations Guidance for the Submission of January 10, 1997 Do Do Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products Proposed Approach to Regulation of February 28, 1997 Do Do Cellular and Tissue-Based Products Tables 1 and 2 from Proposed Approach March 4, 1997 Do Do to Regulation of Cellular and Tissue- Based Products Guidance for Industry--Providing March 13, 1997 Do Do Clinical Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry for the April 10, 1997 Do Do Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies Guidance for Industry--Changes to an July 24, 1997 Do Do Approved Application: Biological Products Guidance for Industry--Changes to an July 24, 1997 Do Do Approved Application for Specified Biotechnology and Specified Synthetic Biological Products [[Page 31233]] Guidance for Industry--Screening and July 29, 1997 Do Do Testing of Donors of Human Tissue Intended for Transplantation Guidance for Industry--Donor Screening August 15, 1997 Do Do for Antibodies to HTLV-II Draft Guidance for Industry on Testing August 25, 1997 Do Do Limits in Stability Protocols for Standardized Grass Pollen Extracts Guidance for Industry--Postmarketing August 27, 1997 Do Do Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report Draft Guidance for Industry Efficacy September 1, 1997 Do Do Evaluation of Hemoglobin-and Perfluorocarbon-Based Oxygen Carriers Guidance for Industry--The Sourcing October 7, 1997 Do Do and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA--Regulated Products for Human Use FDA's Policy Statement Concerning November 25, 1992 Do Do Cooperative Manufacturing Arrangements for Licensed Biologics FDA Guidance Document Concerning Use July 11, 1995 Do Do of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability Advertising and Promotion; Guidance; October 8, 1996 Do Do Notice Interpretative Guidelines of the October 2, 1973 Do Do Source Plasma (Human) Standards Guidelines for Reviewing Amendments to July 20, 1976 Do Do Include Plasmapheresis of Hemophiliacs Package Insert: Immune Serum Globulin March 30, 1978 Do Do (Human) Guidelines for Interpretation of April 12, 1979 Do Do Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus Toxoids Guidelines for Immunization of Source June 1, 1980 Do Do Plasma (Human) Donors with Blood Substances Collection of Human Leukocytes for January 28, 1981 Do Do Further Manufacturing (Source Leukocytes) Platelet Testing Guidelines--Approval July 1, 1981 Do Do of New Procedures and Equipment Revised Guideline for Adding Heparin August 1, 1981 Do Do to Empty Containers for Collection of Heparinized Source Plasma (Human) Guidelines for Meningococcal July 17, 1985 Do Do Polysaccharide Vaccines Guideline for the Uniform Labeling of August 1, 1985 Do Do Blood and Blood Components Guideline for Submitting Documentation February 1, 1987 Do Do for the Stability of Human Drugs and Biologics Guideline for Submitting Documentation February 1, 1987 Do Do for Packaging for Human Drugs and Biologics Guideline On General Principles of May 1, 1987 Do Do Process Validation Guideline On Sterile Drug Products June 1, 1987 Do Do Produced by Aseptic Processing 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 Revised Guideline for the Collection October 7, 1988 Do Do of Platelets, Pheresis Draft Guideline for the Design of November 1, 1988 Do Do Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic Uses Guidelines for Release of Pneumococcal February 1, 1989 Do Do Vaccine, Polyvalent FDA Regulated Industries for Drug September 1, 1989 Do Do Master Files [[Page 31234]] FDA Regulated Industries for October 26, 1989 Do Do Collection of Blood or Blood Products from Donors With Positive Tests for Infectious Disease Markers (``High Risk'' Donors) Guideline for Determination of January 1, 1990 Do Do Residual Moisture in Dried Biological Products Guideline on the Preparation of March 1, 1991 Do Do Investigational New Drug Products (Human & Animal) Draft Guideline for the Validation of September 28, 1993 Do Do Blood Establishment Computer Systems Guideline for Adverse Experience October 15, 1993 Do Do Reporting for Licensed Biological Products Guideline for Quality Assurance in July 11, 1995 Do Do Blood Establishments To In Vitro Diagnostic Reagent December 6, 1986 Do Do Manufacturers: Guidance On the Labeling of Human Blood Derived In Vitro Diagnostic Devices In Regard to Labeling for HTLV-III/LAV Antibody Testing To Biologic Product Manufacturers-- May 3, 1991 Do Do Controlling Materials of Bovine or Ovine Origin To Sponsors of INDs Using Retroviral September 20, 1993 Do Do Vectors To Manufacturers: Bovine Derived December 17, 1993 Do Do Materials (BSE) To Blood Establishment Computer March 31, 1994 Do Do Software Manufacturers To Sponsors of INDs for Human May 23, 1994 Do Do Immunoglobulin Products To Manufacturers of Licensed Anti-HIV May 26, 1994 Do Do Test Kits Letter to Manufacturers of Immune October 3, 1994 Do Do Globulin Intravenous (Human) (IGIV), Aseptic Meningitis Syndrome To Manufacturers of Immune Globulin December 27, 1994 Do Do Products: Testing for Hepatitis C Virus RNA Immunoglobulin To Blood Establishment Computer February 10, 1995 Do Do Software Manufacturers To Manufacturers of Intramuscular March 3, 1995 Do Do Immune Globulin Products: HCV RNA Testing by PCR To Manufacturers of Intramuscular March 13, 1995 Do Do Immune Globulin Products: Additional Information Regarding HCV RNA Testing by PCR To Health Professionals: March 14, 1995 Do Do Implementation of Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular Administration Dear Colleague: Regarding Reverse January 4, 1996 Do Do Transcriptase Activity in Viral Vaccines Produced in Chicken Cells To Manufacturers of FDA-Regulated Drug/ May 9, 1996 Do Do Biological/Device Products, Bovine Spongiform Encephalopathy (BSE) To Manufacturers: Implementation of June 13, 1996 Do Do Testing for Hepatitis C Virus RNA by Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Polymerase Chain Reaction (PCR) of Intramuscular Immune Globulin Preparations To Manufacturers: HIV-1 Group O July 31, 1996 Do Do To All Plasma Derivative Manufacturers October 7, 1996 Do Do and to ABRA: Warning Statement for Plasma Derivative Product Labeling To Biologic Product Manufacturers: December 3, 1996 Do Do Revised Procedures for Internal Labeling Review Number Assignment To Plasma Fractionators--CBER's View May 29, 1997 Do Do on Product Recalls Conducted by the Plasma Fractionation Industry PTC in the Manufacture of In Vitro June 20, 1983 Do Do Monoclonal Antibody Products Subject to Licensure Draft PTC in the Production and July 28, 1983 Do Do Testing of Interferon Intended for Investigational Use in Humans (Interferon Test Procedures) [[Page 31235]] Draft PTC in the Production and April 10, 1985 Do Do Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology Draft PTC in the Manufacture and August 8, 1989 Do Do Clinical Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989) PTC in the Collection, Processing and August 22, 1989 Do Do Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to Humans Cytokine and Growth Factor Pre-Pivotal April 2, 1990 Do Do Trial Information Package PTC in the Safety Evaluation of August 21, 1990 Do Do Hemoglobin-Based Oxygen Carriers PTC in the Design and Implementation March 1, 1992 Do Do of Field Trials for Blood Grouping Reagents and Anti-Human Globulin PTC in the Manufacture of In Vitro March 1, 1992 Do Do Monoclonal Antibody Products for Further Manufacturing into Blood Grouping Reagent and Anti-Human Globulin Supplement to the PTC in the April 6, 1992 Do Do Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability Draft PTC in the Characterization of July 12, 1993 Do Do Cell Lines Used to Produce Biologicals PTC in the Manufacture and Testing of August 22, 1995 Do Do Therapeutic Products for Human Use Derived from Transgenic Animals PTC on Plasmid DNA Vaccines for December 22, 1996 Do Do Preventive Infectious Disease Indications PTC in the Manufacture and Testing of February 28, 1997 Do Do Monoclonal Antibody Products for Human Use Reviewer Guidance, Computer Software April 26, 1995 FDA Personnel Do Informed Consent for Plasmapheresis/ October 1, 1995 Do Do Immunization Draft Reviewers' Guide: Changes in October 1, 1995 Do Do Personnel Disease Associated Antibody Collection October 1, 1995 Do Do Program Reviewer Guidance for a Premarket January 13, 1997 Do Do Notification Submission for Blood Establishment Computer Software Compliance Program Guidance Manual 1994 Do National Technical (Drugs and Biologics) Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703- 605-6050 (Publication No. 94- 920699) Guidance for Industry: Industry- November 1997 FDA regulated Office of Communication, Supported Scientific and Educational industry Training, and Manufacturers Activities Assistance (HFM-40), 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: http://www.fda.gov/ cber To Biologic Product Manufacturers-- December 11, 1997 Do Do Withdrawal 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 Draft Guidance for Industry: Promoting December 1997 Do Do Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS) Dear Doctor Letter--Difficulty in January 28, 1998 Health care providers Do Obtaining Immune Globulin Intravenous (Human) Guidance for Industry: Year 2000 Date January 1998 FDA regulated Do Change for Computer Systems and industry Software Applications Used in the Manufacture of Blood Products [[Page 31236]] Draft Guidance for Industry: Efficacy January 1998 Do Do Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use Draft Guidance for Industry: Container January 1998 Do Do and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products Draft Guidance for Industry: Clinical February 1998 Do Do Development of Programs for Drugs, Devices and Biological Products Intended for Treatment of Osteoarthritis (OA) Draft Guidance for Industry: March 1998 Do Do Manufacturing, Processing or Holding Active Pharmaceutical Ingredients Guidance for Industry: Guidance for March 1998 Do Do Human Somatic Cell Therapy and Gene Therapy Dear Doctor Letter--Standardized Grass May 11, 1998 Health care providers Do Pollen Extracts Draft Guidance for Industry: May 1998 FDA regulated Do Instructions for Submitting industry Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research Draft Guidance for Industry: Pilot May 1998 Do Do Program for Electronic Investigational New Drug (eIND) Applications for Biological Products Draft Guidance for Industry: May 1998 Do Do Electronic Submissions of Case Report Forms (CRFs), Case Report Tabulations (CRTs) and Data to the Center for Biologics Evaluation and Research Draft Guidance for Industry: May 1998 Do Do Electronic Submissions of a Biologics License Application (BLA) or Product License Application (PLA)/ Establishment License Application (ELA) to the Center for Biologics Evaluation and Research Guidance for Industry: Submitting and May 1998 Do Do Reviewing Complete Responses to Clinical Holds Guidance for Industry: Classifying May 1998 Do Do Resubmissions in Response to Action Letters Guidance for Industry: May 1998 Do Do Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis and Impact on Dosing and Labeling Guidance for Industry: Standards for May 1998 Do Do the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements Guidance for Industry: Providing May 1998 Do Do Clinical Evidence of Effectiveness for Human Drugs and Biological Products Draft Guidance for Industry: Stability June 1998 Do Do Testing of Drug Substances and Drug Products ICH Draft Guidance on Specifications: June 9, 1998 Do Do Test 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 Draft Guidance for Industry: Exports June 12, 1998 Do Do and Imports Under the FDA Export Reform and Enhancement Act of 1996 Guidance for Industry: Qualifying for June 1998 Do Do Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Errors and June 1998 Do Do Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing Draft Guidance for Industry: In the July 1998 Do Do Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Virus Type 1 [[Page 31237]] Draft Guidance for Industry: For the July 1998 Do Do Submission of 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 FDA Form 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use'' Guidance for Industry: Implementation July 1998 Do Do of Section 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of Certain Labeling Requirements Guidance for Industry: Environmental July 1998 Do Do Assessment of Human Drug and Biologics Applications Draft Guidance for Industry: July 1998 Do Do Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods Dear Colleague Letter--Use of August 12, 1998 Health care providers Do Haemophilus influenzae Conjugate Vaccines in Combination With DTaP in Infants Dear Doctor Letter--Albumin Use in August 19, 1998 Do Do Seriously Ill Patients Draft Guidance for Industry: Content August 1998 FDA regulated Do and Format of Chemistry, industry Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test Draft Guidance for Industry: August 1998 Do Do Submission of Abbreviated Reports and Synopses in Support of Marketing Applications ICH Guidance on Statistical Principles September 16, 1998 Do Do for Clinical Trials ICH Guidance on Quality of September 21, 1998 Do Do Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products ICH Guidance on Viral Safety September 24, 1998 Do Do Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Change to the Guidance Entitled September 8, 1998 Do Do ``Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood and Blood Products''--Information Sheet 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: September 1998 Do Do Submitting Debarment Certification Statements Guidance for Industry: How to Complete September 1998 Do Do the Vaccine Adverse Reporting System Form (VAERS-1) Guidance for Industry: Fast Track Drug September 1998 Do Do Development Programs--Designation, Development, and Application Review CBER's Year 2000 Letter October 27, 1998 Do Do Draft Guidance for Industry: October 1998 Do Do Developing Medical Imaging Drugs and Biologics Dear Blood Bank/Transfusion Service November 3, 1998 Do Do Director Letter: Hepatitis C Virus Risk Dear Doctor Letter--Important Drug November 13, 1998 Health care providers Do Warning: Immune Globulin Intravenous (Human) Draft Guidance for Industry: Content November 1998 FDA regulated Do and Format of Chemistry, industry Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product [[Page 31238]] Draft Guidance for Industry: In Vivo November 1998 Do Do Drug Metabolism/Drug Interaction Studies--Study Design, Data Analysis and Recommendations for Dosing and Labeling Draft Document: United States Industry December 1997 Do Do Consensus Standard for the Uniform (released Labeling of Blood and Blood November 1998) 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 December 18, 1998 Do Do PCR-Based Reverse Transcriptase Assay Guidance for Industry: FDA Approval of December 1998 Do Do New Cancer Treatment Uses for Marketed Drug and Biological Products Draft Guidance for Industry: Gamma December 1998 Do Do Irradiation of Blood and Blood Components: A Pilot Program for Licensing Draft Guidance for Industry: Content December 1998 Do Do and Format of Geriatric Labeling Dear Healthcare Provider: Important January 25, 1999 Health care providers Do Drug Warning: Safety Information Regarding the use of Abbokinase (Urokinase) Guidance for Industry: Content and January 1999 FDA regulated Do Format of Chemistry, Manufacturing industry and Controls Information and Establishment Description Information for a Vaccine or Related Product Guidance on Amended Procedures for January 1999 Do Do Advisory Panel Meetings Guidance for Industry: Providing January 1999 Do Do Regulatory Submissions in Electronic Format--General Considerations Guidance for Industry: Population February 1999 Do Do Pharmacokinetics Guidance for Industry: For the February 1999 Do Do Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum- Derived Products Guidance for Industry: Clinical February 1999 Do Do Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA) Dear Colleague Letter: Voluntary February 4, 1999 Health care providers Do Recall of Tripedia, DTaP Vaccine ---------------------------------------------------------------------------------------------------------------- III. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity or Internet) ---------------------------------------------------------------------------------------------------------------- Guidance on Medical Device Tracking February 19, 1998 Office of Compliance Division of Small (Docket No. 98D-0132) (OC) Manufacturers Assistance, CDRH, Food and Drug Administration, 1-800-638- 2041 or 301-827-0111 or (FAX) Facts on Demand at 1- 800-899-0381 or Internet at http://www.fda.gov/cdrh Guidance on Lead Wires and Patient March 9, 1998 OC Do Cables Global Harmonization Task Force: Draft October 28, 1998 OC Do Document on the Essentials Principles of Safety and Performance of Medical Devices on a Global Basis Medical Devices: Draft Global July 16, 1998 OC Do Harmonization Task Force Study Group 3 Process Validation Guidance (Draft) [[Page 31239]] Letter to Medical Device Manufacturer February 14, 1995 OC Do on Pentium Processors Guideline for Preparing Notices of November 1, 1985 OC/Bioresearch Do Availability of Investigational Monitoring (BIMO) Medical Devices All Diagnostic Ultrasound February 24, 1986 OC/Division of Do Manufacturers and Importers-Exemption Enforcement I (DOEI) from Reporting Under 21 CFR 1002 General Principles of Software June 9, 1997 OC/DOEI Do Validation; Draft Guidance Exemption from Reporting and September 16, 1981 OC/DOEI Do Recordkeeping Requirements for Certain Sunlamp Product Manufacturers Clarification of Radiation Control March 1, 1989 OC/DOEI Do Regulations for Diagnostic X-ray Equipment (FDA 89-8221) A Guide for the Submission of March 1, 1996 OC/DOEI Do Abbreviated Radiation Safety Reports on Cephalometric X-ray Devices: Defined as Dental Units with an Attachment for Mandible Work that Holds a Cassette and Beam Limiting Device A Guide for the Submission of March 1, 1996 OC/DOEI Do Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-ray Systems A Guide for the Submission of an March 1, 1996 OC/DOEI Do Abbreviated Radiation Safety Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use Guide for the Submission of Initial January 1, 1982 OC/DOEI Do Reports on Diagnostic X-Ray Systems and their Major Components Guideline for the Manufacture of In January 10, 1994 OC/DOEI Do Vitro Diagnostic Products Letter to Medical Device Industry on May 17, 1993 OC/DOEI Do Endoscopy and Laparoscopy Accessories (Galdi) Manufacturers/Assemblers of Diagnostic October 13, 1993 OC/DOEI Do X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) Retention of Records Required by 21 August 24, 1981 OC/DOEI Do CFR 1002 All U.S. Condom Manufacturers, April 7, 1987 OC/Division of Do Importers and Repackagers Enforcement II (DOEII) Letter to Ophthalmologists about June 27, 1997 OC/DOEII Do Lasers for Refractive Surgery Manufacturers and Initial Distributors May 23, 1996 OC/DOEII Do of Hemodialyzers Manufacturers and Users of Lasers for October 10, 1996 OC/DOEII Do Refractive Surgery Shielded Trocars and Needles Used for August 23, 1996 OC/DOEII Do Abdominal Access During Laparoscopy Prospective Manufacturers of Barrier October 31, 1996 OC/DOEII Do Devices Used During Oral Sex for STD Protection Condoms: Inspection and Sampling at April 8, 1987 OC/DOEII Do Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/ 8/87) Guide for Preparing Product Reports September 1, 1995 OC/DOEII Do for Lasers and Products Containing Lasers Hazards of Volume Ventilators and September 15, 1993 OC/DOEII Do Heated Humidifiers Latex Labeling Letter (Johnson) March 18, 1993 OC/DOEII Do Letter--Condom Manufacturers and April 5, 1994 OC/DOEII Do Distributors (included in Condom Packet #398) Letter to Industry, Powered Wheelchair May 10, 1993 OC/DOEII Do Manufacturers from R. M. Johnson Letter to Manufacturers/Repackers April 22, 1994 OC/DOEII Do Using Cotton Manufacturers and Initial Distributors February 3, 1994 OC/DOEII Do of Sharps Containers and Destroyers Used by Health Care Professionals Compliance Guide for Laser Products September 1, 1985 OC/DOEII Do (FDA 86-8260) Dental Handpiece Sterilization (Dear September 28, 1992 OC/DOEII Do Doctor Letter) [[Page 31240]] Ethylene Oxide; Ethylene Chlorohydrin; June 23, 1978 OC/DOEII Do and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of Exposure Letter--Manufacturers, Distributors February 23, 1994 OC/DOEII Do and Importers of Condom Products (included in Condom Packet #398) Letter--Manufacturers, Importers, and February 13, 1989 OC/DOEII Do Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt) (included in Condom Packet #398) Regulatory Requirements for Medical September 1, 1996 OC/DOEII Do Gloves--A Workshop Manual FDA Publication No. 96-4257 Standard Specification for Rubber October 28, 1983 OC/DOEII Do Contraceptives (Condoms) (included in Condom Packet #398) Pesticide Regulation Notice 94-4 June 30, 1994 OC/DOEII Do Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims Open Door Operation of Microwave Ovens March 28, 1980 OC/Division of Do as a Result of Oven Miswiring Enforcement III (DOEIII) Guide for Preparing Abbreviated September 1, 1996 OC/DOEIII Do Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use Final Design Control Inspectional March 1, 1997 OC/DOEIII Do Strategy Abbreviated Reports on Radiation August 1, 1995 OC/DOEIII Do Safety for Microwave Products (Other Than Microwave Ovens)--E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems Design Control Guidance for Medical March 11, 1997 OC/DOEIII Do Device Manufacturers Abbreviated Reports on Radiation August 1, 1995 OC/DOEIII Do Safety of Non-Medical Ultrasonic Products Application for a Variance from 21 CFR March 1, 1987 OC/DOEIII Do 1040.11(c) for a Laser Light Show, Display, or Device Computerized Devices/Processes May 1, 1992 OC/DOEIII Do Guidance--Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes Guidance for the Submission of Cabinet February 1, 1975 OC/DOEIII Do X-Ray System Reports Pursuant to 21 CFR 1020.40 Guide for Preparing Annual Reports on October 1, 1987 OC/DOEIII Do Radiation Safety Testing of Electronic Products (General) Guide for Preparing Annual Reports on September 1, 1995 OC/DOEIII Do Radiation Safety Testing of Mercury Vapor Lamps (replaces FDA 82-8127) Guide for Preparing Annual Reports on September 1, 1995 OC/DOEIII Do Radiation Safety Testing of Sunlamps and Sunlamp Products (replaces FDA 82- 8127) Guide for Preparing Product Reports on September 1, 1995 OC/DOEIII Do Sunlamps and Sunlamp Products (21 CFR 1002) Guide for Preparing Reports on March 1, 1985 OC/DOEIII Do Radiation Safety of Microwave Ovens Guide for Submission of Information on April 1, 1971 OC/DOEIII Do Accelerators Intended to Emit X- Radiation Required Pursuant to 21 CFR 1002.10 Guide for Submission of Information on April 30, 1974 OC/DOEIII Do Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10 Guide for Submission of Information on September 1, 1980 OC/DOEIII Do Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81- 8137) Guide for Submission of Information on March 1, 1973 OC/DOEIII Do Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10 Guide for the filing of Annual Reports July 1, 1980 OC/DOEIII Do for X-Ray Components and Systems Guide for the Submission of Initial September 1, 1984 OC/DOEIII Do Reports on Computed Tomography X-Ray Systems [[Page 31241]] Impact Resistant Lenses: Questions and September 1, 1987 OC/DOEIII Do Answers (FDA 87-4002) (see shelf # 460) Imports Radiation-Producing Electronic November 1, 1988 OC/DOEIII Do Products (FDA 89-8008) Information Requirements for Cookbooks October 31, 1988 OC/DOEIII Do and User and Service Manuals Keeping Medical Devices Safe from July 1, 1995 OC/DOEIII Do Electromagnetic Interference Keeping Up With the Microwave March 1, 1990 OC/DOEIII Do Revolution (FDA Pub No. 91-4160) Laser Light Show Safety--Who's May 1, 1986 OC/DOEIII Do Responsibility (FDA 86-8262) Letter to All Foreign Manufacturers May 28, 1981 OC/DOEIII Do and Importers of Electronic Products for Which Applicable FDA Performance Standards Exist Letter to Trade Association: ReUse of December 27, 1995 OC/DOEIII Do Single-use or Disposable Medical Devices Letter: Changes in Regulations October 27, 1995 OC/DOEIII Do Concerning Records and Reports on Radiation-Emitting Electronic Products Medical Device Electromagnetic OC/DOEIII Do Interference Issues, Problem Reports, Standards, and Recommendations Medical Devices and EMI: The FDA January 1, 1995 OC/DOEIII Do Perspective Policy on Lamp Compatibility September 2, 1986 OC/DOEIII Do (sunlamps) Policy on Maximum Timer Interval and August 21, 1986 OC/DOEIII Do Exposure Schedule for Sunlamp Products Policy on Warning Label Required on June 25, 1985 OC/DOEIII Do Sunlamp Products Quality Assurance Guidelines for February 1, 1991 OC/DOEIII Do Hemodialysis Devices Quality Control Guide for Sunlamp March 1, 1988 OC/DOEIII Do Products (FDA 88-8234) Quality Control Practices for May 1, 1980 OC/DOEIII Do Compliance with the Federal Mercury Vapor Lamp Performance Standard Reporting and Compliance Guide for October 1, 1995 OC/DOEIII Do Television Products including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and Guidance Reporting Guide for Laser Light Shows September 1, 1995 OC/DOEIII Do and Displays (21 CFR 1002) (FDA 88- 8140) Reporting Guide for Product Reports on September 1, 1995 OC/DOEIII Do High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) Reporting of New Model Numbers to June 14, 1983 OC/DOEIII Do Existing Model Families Revised Guide for Preparing Annual September 1, 1995 OC/DOEIII Do Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127) Safety of Electrically Powered September 18, 1996 OC/DOEIII Do Products: Letter To Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memo Suggested State Regulations for January 1, 1982 OC/DOEIII Do Control of Radiation--Volume II Nonionizing Radiation--Lasers (FDA Pub No. 83-8220) Unsafe Patient Lead Wires and Cables September 3, 1993 OC/DOEIII Do Guide for Preparing Annual Reports for September 1, 1996 OC/DOEIII Do Ultrasonic Therapy Products Guide for Preparing Product Reports September 1, 1996 OC/DOEIII Do for Medical Ultrasound Products Guide for Preparing Product Reports August 1, 1996 OC/DOEIII Do for Ultrasonic Therapy Products (physical therapy only) Guide for Establishing and Maintaining March 1, 1988 OC/DOEI & III Do a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264) The FDA Export Reform and Enhancement October 1, 1996 OC/Division of Do Act of 1996/Export Certification Program Operations (DPO) [[Page 31242]] Sec. 300.600 Commercial Distribution September 24, 1987 OC/Office of the Do with Regard to Premarket Notification Director (OD) (Section 510(k)) (CPG 7124.19) Global Harmonization Task Force: August 31, 1998 OC/Office of Do Availability of Draft Documents on Surveillance and Adverse Event and Vigilance Reporting Biometrics (OSB) of Medical Device Events Commercial Distribution/Exhibit Letter April 10, 1992 OC/Other (OT) Do (Use instead of Hile letter) (Display) Working Draft of the Current Good July 1, 1995 OC/OT Do Manufacturing Practice (CGMP) Final Rule Guidance for the Medical Device November 6, 1998 ODE Do Industry on PMA Shell Development and Modular Review Medical Devices Containing Materials November 6, 1998 ODE Do Derived from Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry Frequently Asked Questions on the New October 22, 1998 ODE Do 510(k) Pardigm Guidance to Industry Supplements to May 20, 1998 ODE Do Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Material, and Priority Review Convenience Kits Interim Regulatory May 20, 1997 ODE Do Guidance Kit Certification for 510(k)s July 1997 ODE Do Guidance for Industry--Contents of a July 27, 1998 ODE Do Product Development Protocol Guidance for the Content of Premarket May 28, 1998 ODE Do Submissions for Software Contained in Medical Devices (replaces Reviewer Guidance for Computer-Controlled Medical Devices Undergoing 510(k) Review 8/29/91) New Model Medical Device Development June 3, 1998 ODE Do Process Modifications to Devices Subject to August 6, 1998 ODE Do Premarket Approval--the PMA Supplement Decision Making Process Guidance for Off-the-Shelf Software August 17, 1998 ODE Do Use in Medical Devices PMA/510(k) Expedited Review--Guidance March 20, 1998 ODE Do for Industry and CDRH Staff Guidance on Amended Procedures for March 30, 1998 ODE Do Advisory Panel Meetings `Real-Time' Review Program for April 22, 1997 ODE Do Premarket Approval Application (PMA) Supplements A New 510(k) Paradigm--Alternate March 30, 1998 ODE Do Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Freedom of Information/510(K) Process May 15, 1997 ODE Do Changes Guidance for Submitting January 1, 2000 ODE Do Reclassification Petition Product Development Protocol October 1, 1997 ODE Do Guidance on PMA Interactive Procedures February 19, 1998 ODE Do for Day-100 Meetings and Subsequent Deficiencies--for Use by CDRH and Industry (Docket No. 98D-0079) Procedures for Class II Device February 25, 1998 ODE Do Exemptions from Premarket Notification Guidance for Industry and CDRH Staff (Docket No. 98D-0083) New section 513(f)(2)--Evaluation of February 19, 1998 ODE Do Automatic Class III Designation: Guidance for Industry and CDRH Staff (Docket No. 98D-0082) SMDA Changes--Premarket Notification; April 17, 1992 ODE Do Regulatory Requirements for Medical Devices (510k) Manual Insert #D95-2, Attachment A (Interagency September 15, 1995 ODE Do Agreement between FDA & HCFA) #D95-2, Attachment B (Criteria for September 15, 1995 ODE Do Categorization of Investigational Devices (HCFA) 30-Day Notices and 135-Day PMA February 19, 1998 ODE Do Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket No. 98D- 0080) 510(k) Quality Review Program (blue March 29, 1996 ODE Do book memo) [[Page 31243]] Distribution and Public Availability October 10, 1997 ODE Do of PMA Summary of Safety and Effectiveness Data Packages Document Review by the Office of the June 6, 1996 ODE Do Chief Counsel (Blue Book Memo G96-1)) HCFA Reimbursement Categorization September 15, 1995 ODE Do Determinations for FDA-approved IDEs ODE Executive Secretary Guidance August 7, 1987 ODE Do Manual Determination of Intended Use for February 19, 1998 ODE Do 510(k) Devices: Final Document (Docket No. 98D-0081) Letter--Vascular Graft Industry November 22, 1995 ODE Do (Philip Phillips) Letter to Industry, Powered Wheelchair/ May 26, 1994 ODE Do Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D., M.D. Preamendments Class III Strategy; April 19, 1994 ODE Do SXAlpert 4-of-A-Kind PMA's October 1, 1991 ODE Do Application of the Device Good December 1, 1983 ODE Do Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices CDRH's 510(k)/IDE/PMA Refuse to Accept/ June 30, 1993 ODE Do Accept/File Policies (see #D94-1, #K94-1, & #P94-1) Classified Convenience Kits April 30, 1993 ODE Do Color Additive Petitions (p. II-19 of June 1, 1987 ODE Do PMA Manual) Color Additive Status List (Inspection February 1, 1989 ODE Do Operations Manual) Early Collaboration Meetings Under the February 19, 1998 ODE Do FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff, Final Document (Docket No. 98D-0078) Color Additives for Medical Devices November 15, 1995 ODE Do (Snesko) Deciding When to Submit a 510(k) for a January 10, 1997 ODE Do Change to an Existing Device (see CDRH F-O-D #1935) Device Specific Guidance Documents May 11, 1993 ODE Do (List) FDA Clinical Investigator Information May 1, 1989 ODE Do Sheets FDA Guide for Validation of Biological January 1, 1986 ODE Do Indicator Incubation Time (Source: Sterilization Committee; through Virginia Ross; HFZ-332) FDA Policy For The Regulation Of November 13, 1989 ODE Do Computer Products (DRAFT) (See 2099) Format for IDE Progress Reports January 1, 2000 ODE Do Guidance for Preparation of PMA August 1, 1992 ODE Do Manufacturing Information Guideline for the Monitoring of January 1, 1988 OC/BIMO Do Clinical Investigations Guideline on General Principles of May 1, 1987 ODE Do Process Validation Guideline on Sterile Drug Products June 1, 1987 ODE Do Produced by Aseptic Processing Guideline on Validation of the Limulus December 1, 1987 ODE Do Amebocyte Lysate (LAL) Test as an End- Product Endotoxin Test Indications for Use Statement January 2, 1996 ODE Do Industry Representatives on Scientific March 27, 1987 ODE Do Panels Labeling Reusable Medical Devices for April 1, 1996 ODE Do Reprocessing in Health Care Facilities: FDA Reviewer Guidance (see 1198) Limulus Amebocute Lysate; Reduction of October 23, 1987 ODE Do Samples for Testing Master Files Part III; Guidance on June 1, 1987 ODE Do Scientific and Technical Information Memorandum: Electromagnetic June 13, 1995 ODE Do Compatibility for Medical Devices: Issues and Solutions Methods for Conducting Recall June 16, 1978 ODE Do Effectiveness Checks Necessary Information for Diagnostic November 24, 1987 ODE Do Ultrasound 510(k) (Draft) Perspectives on Clinical Studies for January 1, 2000 ODE Do Medical Device Submissions (Statistical) PMA Review Statistical Checklist January 1, 2000 ODE Do [[Page 31244]] Points to Consider in the June 1, 1984 ODE Do Characterization of Cell Lines Used to Produce Biological Products (from John C. Petricciani, M.D.) Preamendment Class III Devices March 11, 1992 ODE Do Premarket Notification [510(k)] Status March 7, 1994 ODE Do Request Form, revised Premarket Submission Coversheet, January 19, 1995 ODE Do Instructions, and Survey Preproduction Quality Assurance September 1, 1989 ODE Do Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) Proposal for Establishing Mechanisms June 30, 1993 ODE Do for Setting Review Priorities Using Risk Assessment and Allocating Review Resources (include with 926-930) Questions and Answers for the FDA September 3, 1996 ODE Do Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities (see 198) Shelf Life of Medical Devices March 1, 1991 ODE Do Substantial Equivalence (SE) Decision January 1, 1990 ODE Do Making Documentation ATTACHED: `SE' Decision Making Process (Detailed) i.e. the decision making tree Suggested Content for Original IDE February 27, 1996 ODE Do Application Cover Letter--Version 4 Suggestions for Submitting a Premarket April 1, 1993 ODE Do Approval (PMA) Application Threshold Assessment of the Impact of January 1, 1990 ODE Do Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976 Guidance on IDE Policies and January 20, 1998 ODE Do Procedures Viable Bacteriophage in Co2 Laser January 1, 2000 ODE Do Plume: Aerodynamic Size Distribution Deciding When to Submit a 510(k) for a January 10, 1997 ODE/blue Do Change to an Existing Device (blue book memo #K97-1) (see CDRH F-O-D #935) Memorandum of Understanding Regarding August 9, 1996 ODE/blue Do Patient Labeling Review (blue book memo #G96-3)) Continued Access to Investigational July 15, 1996 ODE/blue Do Devices During PMA Preparation and Review (blue book memo) 510(k) Additional Information July 23, 1993 ODE/blue/510k Do Procedures (blue book memo #K93-1) 510(k) Refuse to Accept Procedures May 20, 1994 ODE/blue/510k Do (blue book memo #K94-1) 510(k) Sign-Off Procedures (blue book June 3, 1994 ODE/blue/510k Do memo #K94-2) 510(k) Sterility Review Guidance and February 12, 1990 ODE/blue/510k Do Revision of 11/18/1994 (blue book memo #K90-1) Cover Letter: 510(k) Requirements November 21, 1995 ODE/blue/510k Do During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #95-1) Guidance on the Center for Devices and June 30, 1986 ODE/blue/510k Do Radiological Health's Premarket Notification Review Program (blue book memo #K86-3) Premarket Notification--Consistency of February 28, 1989 ODE/blue/510k Do Reviews (blue book memo #K89-1) Review of 510(k)s for Computer August 29, 1991 ODE/blue/510k Do Controlled Medical Devices (blue book memo #K91-1) Executive Secretaries Guidance Manual August 7, 1987 ODE/blue/gnrl Do G87-3 Consolidated Review of Submissions for October 19, 1990 ODE/blue/gnrl Do Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices (blue book memo #G90-2) Consolidated Review of Submissions for October 19, 1990 ODE/blue/gnrl Do Lasers and Accessories (blue book memo #G90-1) Device Labeling Guidance (blue book March 8, 1991 ODE/blue/gnrl Do memo 91-1 ) Documentation and Resolution of December 23, 1993 ODE/blue/gnrl Do Differences of Opinion on Product Evaluations (blue book memo #G93-1) [[Page 31245]] ODE Regulatory Information for the May 15, 1987 ODE/blue/gnrl Do Office of Compliance--Information Sharing Procedures (blue book memo #G87-2) PMA/510(k) Expedited Review (blue book May 20, 1994 ODE/blue/gnrl Do memoG94-2) PMA/510(k) Triage Review Procedures May 20, 1994 ODE/blue/gnrl Do (blue book memo #G94-1) Review of Laser Submissions (blue book April 15, 1988 ODE/blue/gnrl Do memo #G88-1) Toxicology Risk Assessment Committee August 9, 1989 ODE/blue/gnrl Do (blue book memo #G89-1) Use of International Standard ISO- May 1, 1995 ODE/blue/gnrl Do 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo) (Replaces #G87-1 #8294) Delegation of IDE Actions (blue book April 26, 1988 ODE/blue/ide Do memo #D88-1) Goals and Initiatives for the IDE July 12, 1995 ODE/blue/ide Do Program (blue book memo #D95-1) IDE Refuse to Accept Procedures (blue May 20, 1994 ODE/blue/ide Do book memo #D94-1) Implementation of the FDA/HCFA September 15, 1995 ODE/blue/ide Do Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational Devices, & Att. C- List (blue book memo #D95-2) Overdue IDE Annual Progress Report July 23, 1993 ODE/blue/ide Do Procedures (blue book memo) #D93-1 Review of IDEs for Feasibility Studies May 17, 1989 ODE/blue/ide Do (blue book memo #D89-1) Assignment of Review Documents (blue August 24, 1990 ODE/blue/integ Do book memo #I90-2) Document Review Processing (blue book February 12, 1992 ODE/blue/integ Do memo #I91-1) Integrity of Data and Information May 29, 1991 ODE/blue/integ Do Submitted to ODE (blue book memo #I91- 2) Meetings with the Regulated Industry November 20, 1989 ODE/blue/integ Do (blue book memo #I89-3) Nondisclosure of Financially Sensitive March 5, 1992 ODE/blue/integ Do Information (blue book memo #I92-1) Policy Development and Review February 15, 1990 ODE/blue/integ Do Procedures (blue book memo #I90-1) Telephone Communications Between ODE January 29, 1993 ODE/blue/integ Do Staff and Manufacturers (blue book memo #I93-1) Clinical Utility and Premarket May 3, 1991 ODE/blue/pma Do Approval (blue book memo #P91-1) Criteria for Panel Review of PMA January 30, 1986 ODE/blue/pma Do Supplements (blue book memo #P86-3) Panel Report and Recommendations on April 18, 1986 ODE/blue/pma Do PMA Approvals (blue book memo #P86-5) Panel Review of 'Me-Too' Devices July 1, 1986 ODE/blue/pma Do (blue book memo #P86-6) Panel Review of Premarket Approval May 3, 1991 ODE/blue/pma Do Applications (blue book memo #P91-2) PMA Compliance Program (blue book memo May 3, 1991 ODE/blue/pma Do #P91-3) PMA Filing Decisions (blue book memo May 18, 1990 ODE/blue/pma Do #P90-2) PMA Refuse to File Procedures (blue May 20, 1994 ODE/blue/pma Do book memo #P94-1) PMA Supplements: ODE's letter to April 24, 1990 ODE/blue/pma Do manufacturers; identifies situations which may require the submission of a PMA supplement (when PMA Supplements are required) (blue book memo) #P90-1 PMAs Early Review and Preparation of January 27, 1986 ODE/blue/pma Do Summaries of Safety and Effectiveness (blue book memo #P86-1) Premarket Approval Application (PMA) July 8, 1994 ODE/blue/pma Do Closure (blue book memo #P94-1) [[Page 31246]] Review and Approval of PMAs of October 22, 1990 ODE/blue/pma Do Licensees (blue book memo #P86-4) Review of Final Draft Medical Device August 29, 1991 ODE/blue/pma Do Labeling (blue book memo #P91-4) Distribution and Public Availability October 10, 1997 ODE/blue/pma Do of Premarket Approval Application Summary of Safety and Effectiveness Data Packages (P98-1) PMA Summaries of Safety and June 11, 1993 ODE/blue/pma Do Effectiveness and Federal Register Notices of PMA Approvals--Review by the Office of General Counsel (Revised) (P98-1) PMA Review Schedules (P87-1) March 31, 1988 ODE/blue/pma Do Points to Consider Guidance Document February 3, 1999 ODE/Division of Do on Assayed and Unassayed Quality Clinical Laboratory Control Material Devices (DCLD) Review Criteria for Assessment of October 30, 1996 ODE/DCLD Do Antimicrobial Susceptibility Test Discs Guidance for Submission of June 3, 1998 ODE/DCLD Do Immunohistochemistry Applications to the FDA In Vitro Diagnostic Creatinine Test July 2, 1998 ODE/DCLD Do System In Vitro Diagnostic Bicarbonate/Carbon July 6, 1998 ODE/DCLD Do Dioxide Test System In Vitro Diagnostic Chloride Test July 6, 1998 ODE/DCLD Do System In Vitro Diagnostic Glucose Test July 6, 1998 ODE/DCLD Do System In Vitro Diagnostic Potassium Test July 6, 1998 ODE/DCLD Do System In Vitro Diagnostic Sodium Test System July 6, 1998 ODE/DCLD Do In Vitro Diagnostic Urea Nitrogen Test July 6, 1998 ODE/DCLD Do System In Vitro Diagnostic C-Reactive July 20, 1998 ODE/DCLD Do Immunological Test System In Vitro Diagnostic Calibrators July 20, 1998 ODE/DCLD Do Points To Consider For Hematology September 30, 1997 ODE/DCLD Do Quality Control Materials Guidance for Premarket Submissions for December 30, 1998 ODE/DCLD Do Kits for Screening Drugs of Abuse to be Used by the Consumer Review Criteria for Assessment of November 6, 1996 ODE/DCLD Do Professional Use Human Chorionic Gonadotropin (hCG) in Vitro Diagnostic Devices (IVDs) Letter to IVD Manufacturers on December 22, 1997 ODE/DCLD Do Streamlined PMA Guidance Document for the Submission September 19, 1996 ODE/DCLD Do of Tumor Associated Antigen Premarket Notification [510(k)] to FDA Review Criteria for Assessment of February 21, 1997 ODE/DCLD Do Rheumatoid Factor (RF) In Vitro Diagnostic Devices Using Enzyme- Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephgelometry Guidance for 510(k)s on Cholesterol July 14, 1995 ODE/DCLD Do Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use Assessing the Safety/Effectiveness of October 1, 1988 ODE/DCLD Do Home-use In Vitro Diagnostic Devices (IVDs): Draft Points to Consider Regarding Labeling and Premarket Submissions Data for Commercialization of Original June 10, 1996 ODE/DCLD Do Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers DCLD Tier/Triage lists (include 931) May 31, 1996 ODE/DCLD Do Draft Criteria for Assessment of In August 31, 1995 ODE/DCLD Do Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies Draft Guidance Document for 510(k) July 29, 1992 ODE/DCLD Do Submission of Fecal Occult Blood Tests Draft Guidance Document for 510(k) September 30, 1991 ODE/DCLD Do Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs Draft Guidance Document for 510(k) September 1, 1992 ODE/DCLD Do Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices [[Page 31247]] Draft Guidance for 510(k) Submission September 26, 1991 ODE/DCLD Do of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies Draft Review Criteria for Nucleic Acid June 14, 1993 ODE/DCLD Do Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms Guidance Criteria for Cyclosporine January 24, 1992 ODE/DCLD Do PMAs Draft: Premarketing Approval Review September 10, 1992 ODE/DCLD Do Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Points to Consider for Cervical July 25, 1994 ODE/DCLD Do Cytology Devices Points to Consider for Collection of September 26, 1994 ODE/DCLD Do Data in Support of In-Vitro Device Submissions for 510(k) Clearance Points to Consider for Portable Blood February 20, 1996 ODE/DCLD Do Glucose Monitoring Devices Intended for Bedside Use in the Neonate Nursery Points to Consider for Review of February 1, 1996 ODE/DCLD Do Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996 Review Criteria for In Vitro February 1, 1994 ODE/DCLD Do Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA) Review Criteria for Assessment of July 15, 1994 ODE/DCLD Do Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies Review Criteria for Assessment of May 31, 1991 ODE/DCLD Do Antimicrobial Susceptibility Devices Review Criteria for Assessment of July 15, 1991 ODE/DCLD Do Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers Review Criteria for Assessment of September 27, 1995 ODE/DCLD Do Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) Review Criteria for Assessment of In January 1, 1992 ODE/DCLD Do Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens Review Criteria for Assessment of In July 6, 1993 ODE/DCLD Do Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. (Tuberculosis (TB)) Review Criteria for Assessment of September 17, 1992 ODE/DCLD Do Laboratory Tests for the Detection of Antibodies to Helicobacter pylori Review Criteria for Assessment of February 14, 1996 ODE/DCLD Do Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology Review Criteria for Blood Culture August 12, 1991 ODE/DCLD Do Systems Review Criteria for Devices Assisting May 31, 1990 ODE/DCLD Do in the Diagnosis of C. Difficile Associated Diseases Review Criteria for Devices Intended December 30, 1991 ODE/DCLD Do for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe Review Criteria for In Vitro August 1, 1992 ODE/DCLD Do Diagnostic Devices for Detection of IGM Antibodies to Viral Agents Review Criteria for In Vitro February 15, 1996 ODE/DCLD Do Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic) Review Criteria For Premarket Approval May 15, 1992 ODE/DCLD Do of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 Review Criteria for the Assessment of March 2, 1993 ODE/DCLD Do Allergen-Specific Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using Immunological Test Methodologies [[Page 31248]] Review Criteria for the Assessment of September 1, 1992 ODE/DCLD Do Anti-nuclear Antibodies (ANA) In- Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA) Non-Automated Sphygmomanometer (Blood November 19, 1998 ODE/DCRND Do Pressure Cuff) Guidance Cardiac Monitor Guidance (including November 5, 1998 ODE/Division of Do Cardiotachometer and Rate Alarm) Cardiovascular, Respiratory and Neurological Devices (DCRND) Diagnostic ECG Guidance (Including Non- November 5, 1998 ODE/DCRND Do Alarming ST Segment measurement) Carotid Stent--Suggestions for Content October 26, 1996 ODE/DCRND Do of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) Applications Non-Invasive Blood Pressure (NIBP) March 10, 1997 ODE/DCRND Do Monitor Guidance Guidance for Off-the-Shelf Software June 4, 1997 ODE/DCRND Do Use in Medical Devices; Draft Document Draft Percutaneous Transluminal February 7, 1995 ODE/DCRND Do Coronary Angioplasty Package Insert Template Medical Device Labeling--Suggested August 12, 1997 ODE/DCRND Do Format and Content; Draft Document Draft Intravascular Brachytherapy-- May 24, 1996 ODE/DCRND Do Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications 510(k) Reviewer Guidelines-- January 1, 2000 ODE/DCRND Do Tracheostomy Tubes 868.5800 Balloon Valvuloplasty Guidance For The January 1, 1989 ODE/DCRND Do Submission Of an IDE Application and a PMA Application Rechargeable Battery Preliminary July 12, 1993 ODE/DCRND Do Guidance for Data to be Submitted to FDA in Support of Premarket Notification Applications Review Guidance for Anesthesia May 15, 1991 ODE/DCRND Do Conduction Catheter Coronary and Cerebrovascular Guidewire January 1, 1995 ODE/DCRND Do Guidance Draft Guidance: Human Heart Valve June 21, 1991 ODE/DCRND Do Allografts Draft Replacement Heart Valve Guidance October 14, 1994 ODE/DCRND Do Draft Reviewer Guidance for July 1, 1995 ODE/DCRND Do Ventilators Draft Reviewer Guidance on Face Masks March 16, 1996 ODE/DCRND Do and Shield for CPR Draft Version Cardiac Ablation March 1, 1995 ODE/DCRND Do Preliminary Guidance (Data to be Submitted to FDA in Support Investigation Device Exemption Application Draft Version Electrode Recording March 1, 1995 ODE/DCRND Do Catheter Preliminary Guidance (Data to be Submitted to FDA in Support of Premarket Notifications Excerpts Related to EMI from November November 1, 1993 ODE/DCRND Do 1993 Anesthesiology and Respiratory Devices Branch (to be used with EMI standard) General Guidance Document: Non- September 7, 1992 ODE/DCRND Do Invasive Pulse Oximeter Guidance for Oxygen Conserving Device February 1, 1989 ODE/DCRND Do 510(k) Review 73 BZD 868.5905 Non- continuous Ventilator Class II Reviewer Guidance for Premarket July 19, 1995 ODE/DCRND Do Notification (510(k)) Submissions-- Labeling, Performance and Environmental Testing for Electronic Devices Guidance for Peak Flow Meters for Over- June 1, 1993 ODE/DCRND Do the-Counter Sale Guidance for the Preparation of the April 1, 1990 ODE/DCRND Do Annual Report to the PMA Approved Heart Valve Prostheses Heated Humidifier Review Guidance August 30, 1991 ODE/DCRND Do Implantable Pacemaker Lead Testing September 1, 1989 ODE/DCRND Do Guidance For The Submission of a Section 510(k) Notification Implantable Pacemaker Testing Guidance January 12, 1990 ODE/DCRND Do Policy for Expiration Dating (DCRND October 30, 1992 ODE/DCRND Do RB92-G) [[Page 31249]] Review Guidelines for Oxygen Undated ODE/DCRND Do Generators and Oxygen Equipment Reviewer Guidance for Nebulizers, November 9, 1990 ODE/DCRND Do Metered Dose Inhalers, Spacers and Actuators Reviewer's Guidance for Oxygen August 30, 1991 ODE/DCRND Do Concentrator Electrocardiograph (ECG) Electrode February 11, 1997 ODE/DCRND Do Electrocardiograph (ECG) Lead February 11, 1997 ODE/DCRND Do Switching Adapter Electrocardiograph (ECG) Surface February 11, 1997 ODE/DCRND Do Electrode Tester Guidance on the Content of Premarket December 1, 1995 ODE/Division of Do Notification [510(k)] Submissions for Dental Infection Protective Restraints Control and General Hospital Devices (DDIGD) Guidance for the Preparation of November 27, 1998 ODE/DDIGD Do Premarket Notifications for Dental Composites Neonatal and Neonatal Transport September 18, 1998 ODE/DDIGD Do Incubators Premarket Notifications Reexamination of the Evaluation May 19, 1997 ODE/DDIGD Do Process for Liquid Chemical Sterilant and High Level Disinfectants Further Information on the Regulation August 5, 1997 ODE/DDIGD Do of Liquid Chemical Sterilants and High Level Disinfectants Guidance on the Content and Format of December 18, 1997 ODE/DDIGD Do Premarket Notifications [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants Guidance on the Content and Format of January 16, 1998 ODE/DDIGD Do Premarket Notification [510(k)] Submissions for Surgical Masks Premarket Notification [510(k)] January 13, 1999 ODE/DDIGD Do Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products (Replaces: Guidance on the Content and Format of Premarket Notifications [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products--2/13/98) Guidance on the Content and Format of August 4, 1998 ODE/DDIGD Do Premarket Notification [510(k)] Submissions of Washers and Washer- Disinfectors Devices for the Treatment and/or June 10, 1998 ODE/DDIGD Do Diagnosis of Temporomandibular Joint Dysfunction and/or Orofacial Pain Dental Impression Materials--Premarket August 17, 1998 ODE/DDIGD Do Notification OTC Denture Cushions, Pads, Reliners, August 18, 1998 ODE/DDIGD Do Repair Kits, and Partially Fabricated Denture Kits Dental Cements--Premarket Notification August 18, 1998 ODE/DDIGD Do Groups Capable of Testing for Latex July 28, 1997 ODE/DDIGD Do Skin Sensitization (Addendum to #944) Addendum to: Guidance on Premarket September 19, 1995 ODE/DDIGD Do Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities Guidance Document on Dental Handpieces July 1, 1995 ODE/DDIGD/Dental Do Devices Branch (DDB) 510(k) Guidance for Screw Type August 11, 1992 ODE/DDIGD/DDB Do Endosseous Implants for Prosthetic Attachment 510(k) Information Needed for July 6, 1993 ODE/DDIGD/DDB Do Hydroxyapatite Coated Titanium Endosseous Implants 510(k) Information Needed for August 12, 1993 ODE/DDIGD/DDB Do Metallurgical Endosseous Implants 510(k) Information Needed for Ti- July 13, 1993 ODE/DDIGD/DDB Do Powder Coated Titanium Endosseous Implants Draft Guidance Document for the March 3, 1997 ODE/DDIGD/DDB Do Preparation of Premarket Notification [510(k)'s] for Dental Alloys Guidance Document for the Preparation January 23, 1995 ODE/DDIGD/DDB Do of Premarket Notifications (510(k)'s) for Temporomandibular Joint Implants Guidance for the Arrangement and May 16, 1989 ODE/DDIGD/DDB Do Content of a Premarket Approval (PMA) Application For An Endosseous Implant For Prosthetic Attachment Guidance for the Preparation of January 1, 2000 ODE/DDIGD/DDB Do Premarket Notification [510(k)] for Resorbable Periodontal Barriers [[Page 31250]] Information Necessary for Premarket December 9, 1996 ODE/DDIGD/DDB Do Notification Submissions for Screw- Type Endossesous Implants Outline of Recommended Procedures for January 1, 2000 ODE/DDIGD/DDB Do a Clinical Investigation of Endosseous Implants Under a 510(k) Outline of Recommended Procedures for January 1, 2000 ODE/DDIGD/DDB Do Animal Laboratory Studies of Endosseous Implants Guidance on the Content of Premarket April 1, 1993 ODE/DDIGD/General Do Notification [510(k)] Submissions for Hospital Devices Piston Syringes Branch (GHDB) Draft Supplementary Guidance on the March 1, 1995 ODE/DDIGD/GHDB Do Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick) Guidance on 510(k) Submissions for October 1, 1990 ODE/DDIGD/GHDB Do Implanted Infusion Ports Guidance on Premarket Notification March 16, 1995 ODE/DDIGD/GHDB Do [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters Guidance on the Content of Premarket March 1, 1993 ODE/DDIGD/GHDB Do Notification [510(k)] Submissions for Clinical Electronic Thermometers Guidance on the Content of Premarket March 1, 1993 ODE/DDIGD/GHDB Do Notification [510(k)] Submissions for External Infusion Pumps Guidance on the Content of Premarket April 1, 1993 ODE/DDIGD/GHDB Do Notification [510(k)] Submissions for Hypodermic Single Lumen Needles Guidance on Premarket Notification August 1, 1993 ODE/DDIGD/Infection Do [510(k)] Submissions for Automated Control Devices Endoscope Washers, Washer/ Branch (ICDB) Disinfectors, and Disinfectors Intended for Use in Health Care Facilities Guidance on Premarket Notification August 1, 1993 ODE/DDIGD/ICDB Do [510(k)] Submissions for Surgical Gowns and Surgical Drapes Guidance on the Content and Format of December 6, 1996 ODE/DDIG/ICDB Do Premarket Notification 510(k) Submissions for Liquid Chemical Germicides Guidance on the Content and Format of October 1, 1993 ODE/DDIGD/ICDB Do Premarket Notification [510(k)] Submissions for General Purpose Disinfectants (and 3/9/94 Addendum) Guidance on the Content and Format of October 1, 1993 ODE/DDIGD/ICDB Do Premarket Notification [510(k)] Submissions for Sharps Containers Addendum to Guidance on the Content March 9, 1994 ODE/DDIGD/ICDB Do and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants Guidance on Premarket Notification March 3, 1993 ODE/Division of Do 510(k) for Sterilizers Intended for General and Use in Health Care Facilities Restorative Devices (DGRD) Guidance Document for Powered Suction September 30, 1998 ODE/DGRD Do Pump 510(k)s Guidance Document for Industry and March 18, 1998 ODE/DGRD Do CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices (Replaces: Guidance Document for the Preparation of Investigatinal Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices--8/12/88) Guidance for Content of Premarket April 28, 1998 ODE/DGRD Do Notifications for Esophageal and Tracheal Prostheses Guidance Document for Surgical Lamp July 13, 1998 ODE/DGRD Do 510ks Protocol for Dermal Toxicity Testing January 1, 2000 ODE/DGRD Do for Devices in Contact with Skin (Draft) Guide for 510(k) Review of Processed June 26, 1990 ODE/DGRD Do Human Dura Mater Guide for TENS 510(k) Content (Draft) August 1, 1994 ODE/DGRD Do Guidelines for Reviewing Premarket January 1, 2000 ODE/DGRD Do Notifications that Claim Substantial Equivalence to Evoked Response Stimulators [[Page 31251]] Guidance for Studies for Pain Therapy May 12, 1988 ODE/DGRD Do Devices--General Considerations in the Design of Clinical Studies for Pain-Alleviating Devices Galvanic Skin Response Measurement August 23, 1994 ODE/DGRD Do Devices--Draft Guidance for 510(k) Content Draft Version Guide for Cortical August 10, 1992 ODE/DGRD Do Electrode 510(k) Content Draft Version Neuro Endoscope Guidance July 7, 1994 ODE/DGRD Do Draft Version Guidance for Clinical August 20, 1992 ODE/DGRD Do Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators Draft Version 1--Biofeedback Devices-- August 1, 1994 ODE/DGRD Do Draft Guidance for 510(k) Content Draft Version--Guidance on September 12, 1994 ODE/DGRD Do Biocompatibility Requirements for Long Term Neurological Implants: Part 3--Implant Model Draft Premarket Notification Review June 1, 1994 ODE/DGRD Do Guidance for Evoked Response Somatosensory Stimulators Draft Version Cranial Perforator July 13, 1994 ODE/DGRD Do Guidance ORDB 510(k) Sterility Review Guidance July 3, 1997 ODE/DGRD Do Draft Guidance for Testing MR May 22, 1996 ODE/DGRD Do Interaction with Aneurysm Clips Draft 510(k) Guideline for General May 10, 1995 ODE/DGRD/General Do Surgical Electrosurgical Devices Surgery Devices Brancch (GSDB) Draft Guidance for Arthroscope and May 1994 ODE/DGRD/GSDB Do Accessory 510(k)s Guidance for the Preparation of a August 30, 1994 ODE/DGRD/GSDB Do Premarket Notification for Extended Laparoscopy Devices Guidance on the Content and June 1, 1995 ODE/DGRD/GSDB Do Organization of a Premarket Notification for a Medical Laser Guidance Document for Testing Bone April 20, 1996 ODE/DGRD/Orthopedic Do Anchor Devices Devices Branch (ORDB) 510(k) Information Needed for February 20, 1997 ODE/DGRD/ORDB Do Hydroxyapatite Coated Orthopedic Implants Calcium Phosphate (Ca-P) Coating Draft February 21, 1997 ODE/DGRD/ORDB Do Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants Draft Data Requirements for Ultrahigh March 28, 1995 ODE/DGRD/ORDB Do Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices Draft Guidance Document for Femoral August 1, 1995 ODE/DGRD/ORDB Do Stem Prostheses Draft Guidance Document for Testing May 1, 1995 ODE/DGRD/ORDB Do Acetabular Cup Prostheses Draft Guidance Document for the July 16, 1997 ODE/DGRD/ORDB Do Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements Draft Guidance for the Preparation of April 1, 1993 ODE/DGRD/ORDB Do Premarket Notifications [510(k)s] for Cemented, Semi-Constrained Total Knee Prostheses Draft Guideline for Reviewing Spinal January 9, 1997 ODE/DGRD/ORDB Do Fixation Device Systems Draft of Guidance Document for Testing October 25, 1995 ODE/DGRD/ORDB Do of Orthopedic Implants with Metallic Plasma Sprayed Porous Coatings Subject to Required Post Market Surveillance Draft Outline for a Guidance Document November 1, 1993 ODE/DGRD/ORDB Do for Testing Orthopedic Bone Cement, request for comments by December 10, 1993 Guidance Document for Testing April 20, 1996 ODE/DGRD/ORDB Do Biodegradable Polymer Implant Devices Guidance Document for Testing Non- May 1, 1995 ODE/DGRD/ORDB Do Articulating, ``Mechanically Locked'', Modular Implant Components Guidance Document for Testing April 28, 1994 ODE/DGRD/ORDB Do Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement [[Page 31252]] Guidance Document for the Preparation February 18, 1993 ODE/DGRD/ORDB Do of IDE and PMA Applications for Intra- Articular Prosthetic Knee Ligament Devices Guidance Document for the Preparation January 10, 1995 ODE/DGRD/ORDB Do of Premarket Notification for Ceramic Ball Hip Systems Reviewers Guidance Checklist for February 21, 1997 ODE/DGRD/ORDB Do Intramedullary Rods Reviewers Guidance Checklist for February 21, 1997 ODE/DGRD/ORDB Do Orthopedic External Fixation Devices Electroencephalograph Device Draft June 25, 1997 ODE/DGRD/Plastic and Do Guidance for 510(k) Content Reconstructive Surgery Devices Branch (PRSB) Alternate Suture Labeling Resulting January 11, 1993 ODE/DGRD/PRSB Do from the January 11, 1993, Meeting with HIMA Copy of October 9, 1992 Letter and ODE/DGRD/PRSB Do Original Suture Labeling Guidance Draft Guidance for Preparation of PMA January 18, 1995 ODE/DGRD/PRSB Do Applications for Silicone Inflatable (Saline) Breast Prostheses Draft Guidance for Preparations of FDA May 11, 1992 ODE/DGRD/PRSB Do Submissions of Silicone Gel-Filled Breast Prostheses Draft Guidance for Testing of September 1, 1994 ODE/DGRD/PRSB Do Alternative Breast Prostheses (nonsilicone gel-filled) Draft Guidance for the Preparation of March 31, 1995 ODE/DGRD/PRSB Do a Premarket Notification for a Non- Interactive Wound and Burn Dressing [510(k)] Draft Guidance for the Preparation of April 1, 1995 ODE/DGRD/PRSB Do IDE Submission for Interactive Wound and Burn Dressing Letter: Core Study for Silicone Breast January 11, 1996 ODE/DGRD/PRSB Do Implants Electrical Muscle Stimulator (EMS) July 11, 1985 ODE/DGRD/Restorative Do Labeling Indications, Devices Branch Contraindications, Warnings, etc. (REDB) Technological Reporting for Powered January 1, 1992 ODE/DGRD/REDB Do Muscle Stimulator 510k Submissions Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Beds Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Exercise Equipment Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Heating and Cooling Devices Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Immersion Hyudrobaths Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Powered Muscle Stimulators, and Ultrasound Diathermy and Muscle Stimulators Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment [[Page 31253]] Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles Aqueous Shunts--510(k) Submissions November 16, 1998 ODE/Division of Do Opthalmics Devices (DOD) Guidance for Industry--Guidance October 9, 1998 ODE/DOD Do Document for Nonprescription Sunglasses Third Party Review Guidance for January 31, 1997 ODE/DOD Do Vitreous Aspiration and Cutting Device Premarket Notification (510k) Dear Sponsor Letter Concerning the May 20, 1997 ODE/DOD Do Revocation of 21 CFR Part 813 IOL IDE Regulations Retinoscope Guidance July 8, 1998 ODE/DOD Do Opthalmoscope Guidance July 8, 1998 ODE/DOD Do Slit Lamp Guidance July 8, 1998 ODE/DOD Do Revised Procedures for Adding Lens August 11, 1998 ODE/DOD Do Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lens for Extended Wear Announcement by Dr. Alpert at 7/26/96 August 26, 1996 ODE/DOD Do Ophthalmic Panel Meeting Concerning Manufacturers & Users of Lasers for Refractive Surgery [excimer Announcement: Information for September 22, 1997 ODE/DOD Do Manufacturers & Users of Lasers for Refractive Surgery [excimer] Intraocular Lens (IOL) Guidance October 10, 1997 ODE/DOD Do Document FDA Guidelines for Multifocal May 29, 1997 ODE/DOD Do Intraocular Lens IDE Studies and PMAs Premarket Notification [510(k)] May 12, 1994 ODE/DOD Do Guidance Document for Class II Daily Wear Contact Lenses Contact Lenses: The Better the Care April 1, 1991 ODE/DOD Do the Safer the Wear--FDA Publication No. (FDA) (91-4220) An FDA Survey of U.S. Contact Lens July 1, 1987 ODE/DOD Do Wearers (Carol L. Herman) Reprinted from Contact Lens Spectrum Facts for Consumers from the Federal April 1, 1986 ODE/DOD Do Trade Commission--Eyeglasses Important Information About Rophae August 20, 1992 ODE/DOD Do Intraocular Lenses Checklist of Information Usually October 10, 1996 ODE/DOD Do Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers [excimer] Ophthalmic Device Triage List March 19, 1998 ODE/DOD Do Discussion Points for Expansion of the September 5, 1997 ODE/DOD Do 'Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers' Draft Document Letter to Manufacturers and Users of October 10, 1996 ODE/DOD Do Lasers for Refractive Surgery [excimer] Owners Certification of Lasers as PMA September 26, 1996 ODE/DOD Do Approved Devices [excimer] Update on Excimer Lasers for May 20, 1996 ODE/DOD Do Nearsightedness Amendment 1: Premarket Notification June 28, 1994 ODE/DOD Do [510(k)] Guidance Document for Class II Daily Wear Contact Lenses Certification Statement for the Impact February 3, 1995 ODE/DOD Do Resistance Test Premarket Notification 510(k) Guidance May 1, 1997 ODE/DOD Do for Contact Lens Care Products Eye Valve Implant (and all glaucoma November 16, 1995 ODE/DOD Do drainage devices) manufacturers letter from N. C. Brogdon New FDA Recommendations & Results of May 30, 1989 ODE/DOD Do Contact Lens Study (7-day letter) Sunglass Letter including 510(k) October 8, 1996 ODE/DOD Do format Sunglass Package February 3, 1995 ODE/DOD Do Guidance for Industry; Noise Claims in October 21, 1998 ODE/Division of Do Hearing Aid Labeling Reproductive, Abdominal, ENT, and Radiological Devices (DRAERD) [[Page 31254]] Guidance for the Submission of November 14, 1998 ODE/DRAERD Do Premarket Notification for Magnetic Resonance Diagnostic Devices Guidance for the Content of Premarket November 30, 1998 ODE/DRAERD Do Notifications for Intracorporeal Lithotripters Guidance for the Submission of November 20, 1998 ODE/DRAERD Do Premarket Notifications for Radionuclide Dose Calibrators Guidance for the Submission of December 3, 1998 ODE/DRAERD Do Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems Information for Manufacturers Seeking February 4, 1999 ODE/-DRAERD Do Marketing Clearance of Digital Mammography Systems Harmonic Imaging with/without November 16, 1998 ODE/DRAERD Do Contrast--Premarket Notification Requirements Guidance for the Content of Premarket February 5, 1998 ODE/DRAERD Do Notifications for Metal Expandable Biliary Stents Guidance for the Submission of 510(k) February 11, 1997 ODE/DRAERD Do Premarket Notifications for Cardiovascular Intravascular Filters Tympanostomy Tubes, Submission January 14, 1998 ODE/DRAERD Do Guidance for a 510(k) Premarket Notification Letter to Manufacturers of September 5, 1996 ODE/DRAERD Do Falloposcopes Letter to Manufacturers of September 6, 1996 ODE/DRAERD Do Prescription Home Monitors for Non- Stress Tests Latex Condoms for Men--Information for July 23, 1998 ODE/DRAERD Do 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions Uniform Contraceptive Labeling July 23, 1998 ODE/DRAERD Do Guidance to Industry and CDRH August 7, 1998 ODE/DRAERD Do Reviewers--Guidance for the Content of Premarket Notifications for Conventional and Permeability Hemodialyzers (Replaces: Guidelines for Premarket Testing of New Conventional Hemodialyers, High Premeability Hemodialyzers and Hemofilters) Devices Used for In Vitro September 10, 1998 ODE/DRAERD Do Fertilization and Related Assisted Reproduction Procedures Guidance for the Technical Content of April 1, 1990 ODE/DRAERD Do a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube with Valve Letter: Notice to Manufacturers of September 25, 1997 ODE/DRAERD Do Bone Mineral Densitometers Draft Guidance to Hearing Aid August 5, 1994 ODE/DRAERD/Ear, Nose, Do Manufacturers for Substantiation of and Throat Devices Claims Branch (ENTB) Guidance for Submission of a 510(k) April 1, 1991 ODE/DRAERD/ENTB Do Premarket Notification for an Air Conduction Hearing Aid Guidance For The Arrangement and May 1, 1990 ODE/DRAERD/ENTB Do Content of a Premarket Approval (PMA) Application For a Cochlear Implant in Children Ages 2 through to 17 Years Guidance for the Content of Premarket October 21, 1996 ODE/DRAERD/ENTB Do Notification for Disposable, Sterile, Ear, Nose and Throat Endoscope Sheaths with Protective Barrier Claims Guideline for the Arrangement and May 1, 1990 ODE/DRAERD/ENTB Do Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age Draft Guidance for Hemodialyzer Reuse October 6, 1995 ODE/DRAERD/ Do Labeling Gastroenterology and Renal Devices Branch (GRDB) Draft Guidance for the Content of May 30, 1997 ODE/DRAERD/GRDB Do Premarket Notifications for Water Purification Components and Systems for Hemodialysis Condom Packet: 4/13/94 R. J. Rivera April 13, 1994 ODE/DRAERD/Obstetrics/ Do Letter, Condom Guidance & 7 Tabs, Gynecology Devices General Guidance for Modifying Condom Branch (OGDB) Labeling to Include Shelf Life [[Page 31255]] Draft Guidance for the Content of July 29, 1991 ODE/DRAERD/OGDB Do Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions Draft Guidance for the Content of May 25, 1995 ODE/DRAERD/OGDB Do Premarket Notifications for Menstrual Tampons Draft Thermal Endometrial Ablation March 14, 1996 ODE/DRAERD/OGDB Do Devices (Submission Guidance for an IDE) Guidance (`Guidelines') for Evaluation March 8, 1977 ODE/DRAERD/OGDB Do of Fetal Clip Electrode Guidance (`Guidelines') for Evaluation May 10, 1978 ODE/DRAERD/OGDB Do of Hysteroscopic Sterilization Devices Guidance (`Guidelines') for Evaluation January 1, 2000 ODE/DRAERD/OGDB Do of Laparoscopic Bipolar and Thermal Coagulators (and Accessories) Guidance (`Guidelines') for Evaluation November 22, 1977 ODE/DRAERD/OGDB Do of Tubal Occlusion Devices Guidelines for Evaluation of Non-Drug September 28, 1976 ODE/DRAERD/OGDB Do IUDs Hysteroscopes and Gynecology March 27, 1996 ODE/DRAERD/OGDB Do Laparoscopes--Submission Guidance for a 510(k) --includes 00192 Hysteroscopes and Laparoscopic August 1, 1995 ODE/DRAERD/OGDB Do Insufflators: Submission Guidance for a 510(k) In-vivo Devices for the Detection of June 14, 1997 ODE/DRAERD/OGDB Do Cervical Cancer and its Precursors: Submission Guidance for an IDE Draft Document Intrapartum Continuous Monitors for June 14, 1997 ODE/DRAERD/OGDB Do Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document Premarket Testing Guidelines for November 20, 1992 ODE/DRAERD/OGDB Do Falloposcopes Premarket Testing Guidelines for April 4, 1990 ODE/DRAERD/OGDB Do Female Barrier Contraceptive Devices also Intended to Prevent Sexually Transmitted Diseases Premarket Testing Guidelines for Home March 31, 1993 ODE/DRAERD/OGDB Do Uterine Activity Monitors Information for a Latex Condom 510(k) March 1994 ODE/DRAERD/OGDB Do Submission for Obstetrics-Gynecology Branch (draft) Testing Guidance for Male Condoms Made June 29, 1995 ODE/DRAERD/OGDB Do from New Material (Non-Latex) Draft Guidance for Review of Bone November 9, 1992 ODE/DRAERD/Radiology Do Densitometer 510(k) Submissions Devices Branch (RDB) Guidance for Content and Review of a August 2, 1988 ODE/DRAERD/RDB Do Magnetic Resonance Diagnostic Device 510(k) Application and 10/11/95 MRI Guidance Update for dB/dt Guidance for Magnetic Resonance September 29, 1997 ODE/DRAERD/RDB Do Diagnostic Devices--Criteria for Significant Risk Investigations Guidance for the Comment and Review of August 1, 1993 ODE/DRAERD/RDB Do 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices [See 2099] Guidance for the Submission of 510(k)s June 1, 1997 ODE/DRAERD/RDB Do for Solid State X-ray Imaging Devices Information for Manufacturers Seeking September 30, 1997 ODE/DRAERD/RDB Do Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Information for Manufacturers Seeking June 19, 1996 ODE/DRAERD/RDB Do Marketing Clearance of Digital Mammography Systems Reviewer Guidance for Automatic X-Ray February 1, 1990 ODE/DRAERD/RDB Do Film Processor 510(k) Simplified 510(k) procedures for December 21, 1993 ODE/DRAERD/RDB Do certain radiology devices: 12/21/93 letter from L. Yin, ODE/DRAERD, to NEMA 510(k) Checklist for Sterile September 19, 1994 ODE/DRAERD/Urology Do Lubricating Jelly Used With and Lithrotripsy Transurethral Surgical Instruments Devices Branch (ULDB) Draft Guidance to Firms on Biliary August 2, 1990 ODE/DRAERD/ULDB Do Lithotripsy Studies CDRH Interim Regulatory Policy for September 10, 1997 ODE/DRAERD/ULDB Do External Penile Rigidity Devices Checklist for Mechanical Lithotripters November 1, 1994 ODE/DRAERD/ULDB Do and Stone Dislodgers Used in Gastroenterology and Urology [[Page 31256]] Draft--510(k) Checklist for November 23, 1994 ODE/DRAERD/ULDB Do Conditioned Response Enuresis Alarms Draft 510(k) Checklist for Condom February 23, 1995 ODE/DRAERD/ULDB Do Catheters Draft 510(k) Checklist for Endoscopic August 16, 1995 ODE/DRAERD/ULDB Do Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology Draft 510(k) Checklist for Endoscopic June 22, 1995 ODE/DRAERD/ULDB Do Light Sources Used in Gastroenterology and Urology Draft 510(k) Checklist for Non- June 6, 1995 ODE/DRAERD/ULDB Do Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence Draft 510(k) Checklist for Urological August 1, 1995 ODE/DRAERD/ULDB Do Irrigation System and Tubing Set Draft Guidance for Clinical November 11, 1994 ODE/DRAERD/ULDB Do Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) Draft Guidance for Information on February 5, 1992 ODE/DRAERD/ULDB Do Clinical Safety and Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi Draft Guidance for Preclinical and November 29, 1995 ODE/DRAERD/ULDB Do Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence Draft Guidance for Preparation of PMA March 16, 1993 OD/DRAERD/ULDB Do Applications for Penile Inflatable Implants Draft Guidance for Preparation of PMA March 16, 1993 ODE/DRAERD/ULDB Do Applications for Testicular Prostheses Draft Guidance for Preparation of PMA May 1, 1995 ODE/DRAERD/ULDB Do Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter) Draft Guidance for the Clinical November 2, 1995 ODE/DRAERD/ULDB Do Investigation of Urethral Stents Draft Guidance for the Content of March 17, 1995 ODE/DRAERD/ULDB Do Premarket Notifications for Endoscopes Used in Gastroenterology and Urology Draft Guidance for the Content of May 30, 1995 ODE/DRAERD/ULDB Do Premarket Notifications for Penile Rigidity Implants Draft Guidance for the Content of January 24, 1992 ODE/DRAERD/ULDB Do Premarket Notifications for Urological Balloon Dilatation Catheters Draft Guidance Outline--Points to November 30, 1993 ODE/DRAERD/ULDB Do Consider for Clinical Studies for Vasovasostomy Devices Draft of Suggested Information for January 18, 1991 ODE/DRAERD/ULDB Do Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements Guidance for the Content of Premarket February 10, 1993 ODE/DRAERD/ULDBDo Notifications for Biopsy Devices Used in Gastroenterology and Urology Guidance for the Content of Premarket September 12, 1994 ODE/DRAERD/ULDB Do Notifications for Conventional and Antimicrobial Foley Catheters Guidance for the Content of Premarket February 10, 1993 ODE/DRAERD/ULDB Do Notifications for Ureteral Stents Guidance for the Content of Premarket June 7, 1994 ODE/DRAERD/ULDB Do Notifications for Urine Drainage Bags Guidance for the Content of Premarket July 29, 1994 ODE/DRAERD/ULDB Do Notifications for Urodynamic/ Uroflowmetry Systems Guidance to Manufacturers on the January 1, 2000 ODE/DRAERD/ULDB Do Development of Required Postapproval Epidemiologic Study Protocols for Testicular Implants Center for Devices and Radiological June 30, 1993 ODE/IDE/blue/ Do Health's Investigational Device Exemption (IDE) Refuse to Accept Policy Center for Devices and Radiological June 30, 1993 ODE/510k/blue/ Do Health's Premarket Notification [510(k)] Refuse to Accept Policy-- (updated Checklist 3/14/95) [[Page 31257]] Guidance For Request and Issuance of October 21, 1998 Office of Health and Do Interim Notice Letters for Industry Programs Mammography Facilities Under the MQSA (OHIP)/Division of Mammography Quality and Radiation Programs (DMQRP) Continuing Education Credits for March 17, 1998 OHIP/DMQRP Do Reading/ Writing Articles/Papers and Presenting Courses/Lectures Accidental Radioactive Contamination August 13, 1998 OHIP/DMQRP Do of Human Food and Animal Feeds: Recommendations for State and Local Agencies Additional Mammography Review Policy March 26, 1998 OHIP/DMQRP Do Guidance For Review of Cases of March 26, 1998 OHIP/DMQRP Do Possible Suspension or Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) Guidance for Review of Requests for March 26, 1998 OHIP/DMQRP Do Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) Guidance for Submission of Requests March 26, 1998 OHIP/DMQRP Do for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b) Supplement to The Physician's April 9, 1998 OHIP/DMQRP Do Continuing Experience Requirement Requalification for Interpreting May 28, 1998 OHIP/DMQRP Do Physician's Continuing Experience MQSA Policy Statements in a Question June 2, 1998 OHIP/DMQRP Do and Answer Compliance Guidance: The Mammography August 27, 1998 OHIP/DMQRP Do Quality Standards Act Final Regulations MQSA Policy Statements for the Interim August 6, 1998 OHIP/DMQRP Do Regulations Policy for Facilities Changing April 15, 1998 OHIP/DMQRP Do Accreditation Bodies Addendum to What a Mammography July 31, 1996 OHIP/DMQRP Do Facility Should do to Prepare for an MQSA Inspection Handbook of Selected Tissue Doses for September 1, 1995 OHIP/DMQRP Do Fluoroscopic and Cineangiographic Examination of the Coronary Arteries (in SI Units) FDA 95-8289, (Units of milliray (mmmGy) tissue dose and gray (Gy) air kerma) What a Mammography Facility Should Do June 30, 1995 OHIP/DMQRP Do to Prepare for an MQSA Inspection Policy Notebook in a Q/A Format January 23, 1998 OHIP/DMQRP Do (update to existing document) Guidance for Staff, Industry, and October 30, 1998 OHIP/Division of Do Third Parties Implementation of Third Small Manufacturer's Party Programs Under the FDA Assistance (DSMA) Modernization Act of 1997 Pages 39.html Exporting Medical June 30, 1998 OHIP/DSMA Do Devices and 391.html Foreign Liaison List Guidance for Staff, Industry and Third January 6, 1999 OHIP/DSMA Do Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA) A Pocket Guide to Device GMP November 1, 1991 OHIP/DSMA Do Inspections--Inspections of Medical Device Manufacturers and GMP Regulation Requirements Medical Device Reporting for March 1997 OHIP/DSMA Do Manufacturers Regulatory Requirement for Devices for August 1, 1987 OHIP/DSMA Do the Handicapped (FDA 87-4221) Comparison Chart: 1996 Quality System January 1, 2000 OHIP/DSMA Do Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (include 126) Small Business Guide to FDA (FDA 96- January 1, 1996 OHIP/DSMA Do 1092) Investigational Device Exemptions July 1, 1996 OHIP/DSMA Do [IDE] Manual (FDA 96-4159)/DSMA An Introduction to Medical Device January 1, 1992 OHIP/DSMA Do Regulations (FDA 92-4222) [[Page 31258]] In Vitro Diagnostic Devices: Guidance January 1, 1997 OHIP/DSMA Do for the Preparation of 510(k) Submissions (supersedes FDA 87-4224) Instructions for Completion of Medical July 1, 1997 OHIP/DSMA Do Device Registration and Listing Forms FDA 2891, 2891a and 2892 Additional Guidance for Testing September 1, 1993 OHIP/DSMA Do Immunity to Radiated Electromagnetic Fields--Infant Apnea Monitor Standard Classification Names for Medical March 1, 1995 OHIP/DSMA Do Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246) Labeling--Regulatory Requirements for September 1, 1989 OHIP/DSMA Do Medical Devices (FDA 89-4203) List of Current CDRH Addresses for July 30, 1996 OHIP/DSMA Do Report Submission and Ordering of CDRH Forms Obtaining CDRH Guidance Documents May 13, 1998 OHIP/DSMA Do Premarket Approval (PMA) Manual (FDA July 1, 1997 OHIP/DSMA Do 97-4214) Premarket Notification: 510(k)-- August 1, 1995 OHIP/DSMA Do Regulatory Requirements for Medical Devices (FDA 95-4158) Procedures for Laboratory Compliance May 1, 1986 OHIP/DSMA Do Testing of Television Receivers--Part of TV Packet Regulation of Medical Devices May 1, 1996 OHIP/DSMA Do Background Information for Foreign Officials MDR Documents Access Information May 10, 1996 OHIP/DSMA Do MDR Documents Access Information for February 29, 1996 OHIP/DSMA Do CDRH Electronic Docket (ED) MDR Documents Access Information for February 29, 1996 OHIP/DSMA Do CDRH Facts-On-Demand (FOD) MDR Documents Access Information for May 8, 1996 OHIP/DSMA Do Industry Organizations MDR Documents Access Information for May 10, 1996 OHIP/DSMA Do National Technical Information Service (NTIS) MDR Documents Access Information for February 29, 1996 OHIP/DSMA Do World Wide Web (WWW) Medical Device Quality Systems Manual: December 1, 1996 OHIP/DSMA Do A Small Entity Compliance Guide Overview of FDA Modernization Act of February 19, 1998 OHIP/DSMA Do 1997, Medical Device Provisions Medical Device Appeals and Complaints-- February 1, 1998 OHIP/DSMA/Office of Do Guidance on Dispute Resolutions the Center Director (OCD) Medical Device Reporting for User April 1996 OHIP/Division of Do Facilities Device User Programs and Systems Analysis (DUPSA) Human Factors Points to Consider for January 17, 1997 OHIP/DUPSA Do IDE Devices Human Factors Principles for Medical September 1, 1993 OHIP/DUPSA Do Device Labeling Write it Right August 1, 1993 OHIP/DUPSA Do Do It By Design--An Introduction to December 1, 1996 OHIP/DUPSA Do Human Factors in Medical Devices FDA Modernization Act of 1997: February 6, 1998 OHIP/Regs Do Guidance for the Device Industry on Implementation of Highest Priority Provisions: Availability Statistical Aspects of Submissions to June 1, 1984 OSB/Division of Do FDA: A Medical Device Perspective Biostatistics (DB) (also includes as Appendix the Article Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions Statistical Guidance for Clinical January 1, 1996 OSB/DB Do Trials of Non Diagnostic Medical Devices (Replaces Clincal Study Guidance, formerly 891) Amendment to Guidance on Discretionary March 30, 1994 OSB/Division of Do Postmarket Surveillance on Pacemaker Postmarket Leads Surveillance (DPS) Guidance on Procedures to Determine February 19, 1998 OSB/DPS Do Application of Postmarket Surveillance Strategies Guidance on Procedures for Review of February 19, 1998 OSB/DPS Do Postmarket Surveillance Submissions SMDA to FDAMA: Guidance on FDA's February 19, 1998 OSB/DPS Do Transition Plan for Existing Postmarket Surveillance [[Page 31259]] Proposed Draft Guidance to Sponsors October 7, 1994 OSB/DPS Do Regarding Required Postmarket Surveillance Studies of Plasma- Sprayed Porous-Coated Hip Prostheses Guidance to Sponsors on the June 9, 1993 OSB/DPS Do Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads) Medical Device Reporting for April 1996 OSB/Division of Do Distributors Surveillance Systems (DSS) Medical Device Reporting: An Overview April 1996 OSB/DSS Do MDR Internet List Server (listserv) August 29, 1996 OSB/DSS Do Instruction Sheet MEDWATCH FDA Form 3500A For Use By June 1, 1993 OSB/DSS Do User Facilities, Distributors and Manufacturers for Mandatory Reporting Instructions for Completing FDA Form December 15, 1995 OSB/DSS Do 3500A with Coding Manual for Form 3500A (MEDWATCH) MDR Policy/Guidance for Endosseus December 1992 OSB/DSS Do Implant Devices MDR Guidance--Blood Loss Policy December 1995 OSB/DSS Do Summary Reporting Approval for Adverse July 31, 1997 OSB/DSS Do Events Common Problems: Baseline Reports and OSB/DSS Do MedWatch Form 3500A (letter to manufacturer--undated) MDR Guidance Document: Remedial Action July 30, 1996 OSB/DSS Do Exemption--E1996001 Variance from Manufacturer Report July 16, 1996 OSB/DSS Do Number Format [MDR letter] Instructions for Completing Form 3417: March 31, 1997 OSB/DSS Do Medical Device Reporting Baseline Report [MDR] MDR Guidance Document No. 1--IOL-- August 7, 1996 OSB/DSS Do E1996004 MDR Guidance Document No. 3-- August 9, 1996 OSB/DSS Do Needlestick & Blood Exposure-- E1996003 MDR Reporting Guidance For Breast August 7, 1996 OSB/DSS Do Implants--E1996002 Instructions for Completing Semi- September 24, 1996 OSB/DSS Do Annual Report, Form 3419 (MDR) Guidance on FDA's Expectations of May 15, 1998 Office of Standards Do Medical Device Manufacturers and Technology (OST)/ Concerning the Year 2000 Date Division of Electronics and Computer Science (DECS) Draft Document--A Primer on Medical February 7, 1997 OST/Division of Do Device Interactions with Magnetic Postmarket Resonance Imaging Systems Surveillance (DPS) Frequently Asked Questions on February 19, 1998 OST/OD Do Recognition of Consensus Standards Guidance on the Recognition and Use of February 19, 1998 OST/OD Do Consensus Standards ---------------------------------------------------------------------------------------------------------------- IV. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail, Activity or Internet) ---------------------------------------------------------------------------------------------------------------- Aerosol Steroid Product Safety January 12, 1998 Advertising Drug Information Branch (HFD- Information in Prescription Drug 210), CDER, Food and Drug Advertising and Promotional Labeling Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573, or via Internet at http:// www.fda.gov/cder/guidance/ index.htm Dissemination of Reprints of Certain October 8, 1996 Do Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts [[Page 31260]] Consumer-Directed Broadcast August 12, 1997 Advertising draft Do Advertisements Promoting Medical Products in a January 5, 1998 Do Do Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) Alprazolam Tablets In Vivo November 27, 1992 Biopharmaceutic Do Bioequivalence and In Vitro Dissolution Testing Bioavailability Policies and Do Do Guidelines Bumetanide Tablets In Vivo April 23, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Buspirone Hydrochloride Tablets In May 15, 1998 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Captopril Tablets In Vivo May 13, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Carbidopa and Levodopa Tablets In Vivo June 19, 1992 Do Do Bioequivalence and In Vitro Dissolution Testing Cefactor Capsules and Suspension In April 23, 1993 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Cholestyramine Powder In Vitro July 15, 1993 Do Do Bioequivalence Cimetidine Tablets In Vivo June 12, 1992 Do Do Bioequivalence and In Vitro Dissolution Testing Clozapine (Tablets) In Vivo November 15, 1996 Do Do Bioequivalence and In Vitro Dissolution Testing Corticosteroids, Dermatologic June 2, 1995 Do Do (topical) In Vivo Diclofenac Sodium (tablets) In Vivo October 6, 1994 Do Do Bioequivalence and In Vitro Dissolution Testing Diflunisal Tablets In Vivo May 16, 1992 Do Do Bioequivalence and In Vitro Dissolution Testing Diltiazen Hydrochloride Tablets In May 16, 1992 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Dissolution Testing of Immediate August 25, 1997 Do Do Release Solid Oral Dosage Forms Extended Release Oral Dosage Forms: September 26, 1997 Do Do Development, Evaluation, and Application of In Vitro/In Vivo Correlations Flurbiprofen (tablets) In Vivo June 8, 1995 Do Do Bioequivalence and In Vitro Dissolution Testing Gemfibrozil Capsules or Tablets In June 15, 1992 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Glipizide (Tablets) In Vivo April 23, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Guanabenz Acetate Tablets In Vivo April 23, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Hydroxchloroquine Sulfate (tablets) In December 28, 1995 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Indapamide (tablets) In Vivo April 23, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Ketoprofen (capsules) In Vivo April 23, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Leucovorin Calcium (tablets) In Vivo August 4, 1988 Do Do Bioequivalence and In Vitro Dissolution Testing Medroxyprogesterone Acetate (tablets) September 17, 1987 Do Do In Vivo Bioequivalence and In Vitro Dissolution Testing Metaproferenol Sulfate and Albuterol June 27, 1989 Do Do Metered Dose Inhalers In Vitro Metoprolol Tartrate (tablets) In Vivo June 12, 1992 Do Do Bioequivalence and In Vitro Dissolution Testing Nadolol (tablets) In Vivo May 16, 1992 Do Do Bioequivalence and In Vitro Dissolution Testing Naproxen (tablets) In Vivo June 8, 1995 Do Do Bioequivalence and In Vitro Dissolution Testing Nortriptyline Hydrochloride (capsules) June 12, 1992 Do Do In Vivo Bioequivalence and In Vitro Dissolution Testing Oral Extended (controlled) Release In September 9, 1993 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Pentoxifyline (extended-release December 22, 1995 Do Do tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing Phenytoin/Phenytoin Sodium (capsules, March 4, 1994 Do Do tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing [[Page 31261]] Pindolol (tablets) In Vivo April 23, 1993 Do Do Bioequivalence and In Vitro Dissolution Testing Piroxicam (capsules) In Vivo June 15, 1992 Do Do Bioequivalence and In Vitro Dissolution Testing Potassium Chloride (slow-release June 6, 1994 Do Do tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing Rantidine Hydrochloride (tablets) In April 23, 1993 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Selegiline Hydrochloride (tablets) In December 22, 1995 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Statistical Procedure for July 1, 1992 Do Do Bioequivalence Studies Using a Standard Two-Treatment Crossover Design Trazodone Hydrochloride (tablets) In April 30, 1988 Do Do Vivo Bioequivalence and In Vitro Dissolution Testing Antifungal (topical) February 24, 1990 Biopharmaceutic draft Do Antifungal (vaginal) February 24, 1990 Do Do Bioanalytical Methods Validations for January 5, 1999 Do Do Human Studies Food-Effect Bioavailability and December 30, 1997 Do Do Bioequivalence Studies In Vivo Bioequivalence Studies Based December 30, 1997 Do Do on Population and Individual Bioequivalence Approaches Topical Dermatological Drug Product June 18, 1998 Do Do NDAs and ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies Waiver Policy March 29, 1993 Do Do Glyburide Tablets In Vivo April 23, 1993 Biopharmaceutic Do Bioequivalence and In Vitro testing Dissolution Testing Drug Master Files September 1, 1989 Chemistry Do Environmental Assessment of Human July 27, 1998 Do Do Drugs and Biologics Applications FDA's Policy Statement for the May 1, 1992 Do Do Development of New Stereoisomeric Drugs Format and Content for the CMC Section September 1, 1994 Do Do of an Annual Report Format and Content of the Chemistry, February 1, 1987 Do Do Manufacturing and Controls Section of an Application Format and Content of the Microbiology February 1, 1987 Do Do Section of an Application PAC-ALTS: Postapproval Changes-- April 28, 1998 Do Do Analytical Testing Laboratory Sites Reviewer Guidance: Validation of November 1, 1994 Do Do Chromatographic Methods Submission of Chemistry, Manufacturing November 1, 1994 Do Do and Controls Information for Synthetic Peptide Substances Submission of Documentation for November 1, 1994 Do Do Sterilization Process Validation Applications for Human and Veterinary Drug Products Submitting Documentation for Packaging February 1, 1987 Do Do for Human Drugs and Biologics Submitting Documentation for the February 1, 1987 Do Do Manufacturing of and Controls for Drug Products Submitting Documentation for the February 1, 1987 Do Do Stability of Human Drugs and Biologics Submitting Supporting Documentation in February 1, 1987 Do Do Testing Drug Applications for the Manufacture of Drug Substances Submitting Samples and Analytical Data February 1, 1987 Do Do for Methods Validation SUPAC-IR--Immediate-Release Solid Oral November 30, 1995 Do Do Dosage Forms: Scale-Up and Post- Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation SUPAC-IR: Immediate Release Solid Oral October 21, 1997 Do Do Dosage Forms; Manufacturing Equipment Addendum SUPAC-IR Questions and Answers February 18, 1997 Do Do [[Page 31262]] SUPAC-MR: Modified Release Solid Oral October 6, 1997 Do Do Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation SUPAC-SS--Nonsterile Semisolid Dosage June 13, 1997 Do Do Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation BACPAC I: Intermediates in Drug November 30, 1998 Chemistry draft Do Substance Synthesis (Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation) Content and Format of Investigational December 10, 1997 Do Do New Drug Applications (INDs) for Phases 2 and 3 Studies of Drugs, Including Specific Therapeutic Biotechnology-Derived Products-- Preliminary Draft Metered Dose Inhalers (MDI) and Dry November 19, 1998 Do Do Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation NDAs: Impurities in Drug Substances January 21, 1999 Do Do Stability Testing of Drug Substances June 8, 1998 Do Do and Drug Products Submission of Documentation in Drug July 15, 1997 Do Do Applications for Container Closure Systems Used for the Packaging of Human Drugs and Biologics Submitting Supporting Chemistry November 1, 1991 Do Do Documentation in Radiopharmaceutical Drug Applications SUPAC-IR/MR: Immediate Release and April 28, 1998 Do Do Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum SUPAC-SS: Nonsterile Semisolid Dosage January 5, 1999 Do Do Forms Tracking of NDA and ANDA Do Do Reformulations for Solid, Oral, Immediate Release Drug Products Acute Bacterial Exacerbation of July 22, 1998 Clinical Do Chronic Bronchitis; Developing antimicrobial draft Antimicrobial Drugs for 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 or Chronic Bacterial July 22, 1998 Do Do Prostatitis; Developing Antimicrobial Drugs for Treatment Acute Otitis Media; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment Bacterial Vaginosis; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment Community Acquired Pneumonia; July 22, 1998 Do Do Developing Antimicrobial Drugs for Treatment Complicated Urinary Tract Infections July 22, 1998 Do Do and Pylonephritis; Developing Antimicrobial Drugs for Treatment Empiric Therapy of Febrile July 22, 1998 Do Do Neutropenia; Developing Antimicrobial Drugs for Treatment General Considerations for Clinical July 22, 1998 Do Do Trials; Developing Antimicrobial Drugs for Treatment Lyme Disease; Developing Antimicrobial July 22, 1998 Do Do Drugs for Treatment Nosocomial Pneumonia; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment Secondary Bacterial Infections of July 22, 1998 Do Do Acute Bronchitis; Developing Antimicrobial Drugs for Treatment Streptococcal Pharyngitis and July 22, 1998 Do Do Tonsillitis; Developing Antimicrobial Drugs for Treatment Uncomplicated Gonorrhea--Cervical, July 22, 1998 Do Do Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment Uncomplicated Urinary Tract July 22, 1998 Do Do Infections; Developing Antimicrobial Drugs for Treatment [[Page 31263]] Uncomplicated and Complicated Skin and July 22, 1998 Do Do Skin Structure Infections; Developing Antimicrobial Drugs for Treatment Vuvlovaginal Candidiasis; Developing July 22, 1998 Do Do Antimicrobial Drugs for Treatment Clinical Evaluation of Antidepressant September 1, 1977 Clinical medical Do Drugs Clinical Evaluation of Antidiarrheal September 1, 1977 Do Do Drugs Clinical Evaluation of Antiepileptic January 1, 1981 Do Do Drugs (adults and children) Clinical Evaluation of Combination March 20, 1995 Do Do Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women Clinical Evaluation of October 1, 1981 Do Do Radiopharmaceutical Drugs Clinical Evaluation of Analgesic Drugs December 1, 1992 Do Do Clinical Evaluation of Antacid Drugs April 1, 1978 Do Do Clinical Evaluation of Anti- April 1, 1988 Do Do Inflammatory and Antirheumatic Drugs (adults and children) Clinical Evaluation of Anti-Anxiety September 1, 1977 Do Do Drugs Clinical Evaluation of Anti-Infective September 1, 1977 Do Do Drugs (Systemic) Clinical Evaluation of Drugs to November 1, 1978 Do Do Prevent, Control and/or Treat Periodontal Disease Clinical Evaluation of Gastric September 1, 1977 Do Do Secretory Depressant (GSD) Drugs Clinical Evaluation of General May 1, 1982 Do Do Anesthetics Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do Do Clinical Evaluation of Laxative Drugs April 1, 1978 Do Do Clinical Evaluation of Local May 1, 1982 Do Do Anesthetics Clinical Evaluation of Psychoactive July 1, 1979 Do Do Drugs in Infants and Children Content and Format for Pediatric Use May 24, 1996 Do Do Supplements Content and Format of Investigational November 20, 1995 Do Do New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products Development of Vaginal Contraceptive April 19, 1995 Do Do Drugs (NDA) FDA Approval of New Cancer Treatment February 2, 1999 Do Do Uses for Marketed Drug and Biological Products FDA Requirements for Approval of Drugs June 20, 1989 Do Do to Treat Superficial Bladder Cancer FDA Requirements for Approval of Drugs January 29, 1991 Do Do to Treat Non-Small Cell Lung Cancer Format and Content of the Clinical and July 1, 1988 Do Do Statistical Sections of an Application Format and Content of the Summary for February 1, 1987 Do Do New Drug and Antibiotic Applications Formatting, Assembling and Submitting February 1, 1987 Do Do New Drug and Antibiotic Applications General Considerations for the September 1, 1977 Do Do Clinical Evaluation of Drugs in Infants and Children General Considerations for the December 1, 1978 Do Do Clinical Evaluation of Drugs Oncologic Drugs Advisory Committee April 13, 1988 Do Do Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer Oncologic Drugs Advisory Committee April 19, 1988 Do Do Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer OTC Treatment of Hypercholesterolemia October 27, 1997 Do Do Points to Consider: Clinical September 19, 1994 Do Do Development Programs for MDI and DPI Drug Products Points to Consider in the Clinical October 26, 1992 Do Do Development and Labeling of Anti- Infective Drug Products Points to Consider in the Preclinical May 1, 1993 Do Do Development of Immunomodulatory Drugs for the Treatment of HIV Infection and Associated Disorders Points to Consider in the Preclinical November 1, 1990 Do Do Development of Antiviral Drugs [[Page 31264]] Postmarketing Adverse Experience August 27, 1997 Do Do Reporting for Human Drugs and Licensed Biological Products; Clarification of What to Report Postmarketing Reporting of Adverse March 1, 1992 Do Do Drug Experiences Preparation of Investigational New November 1, 1992 Do Do Drug Products (Human and Animal) Providing Clinical Evidence of May 15, 1998 Do Do Effectiveness for Human Drug and Biological Products Study and Evaluation of Gender July 22, 1993 Do Do Differences in the Clinical Evaluation of Drugs Study of Drugs Likely to be Used in November 1, 1989 Do Do the Elderly Abuse Liability Assessment July 1, 1990 Clinical medical Do draft Clinical Development Programs for February 18, 1998 Do Do Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) Clinical Development Programs for March 18, 1998 Do Do Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) Clinical Evaluation of May 1, 1988 Do Do Antihypertensive Drugs Clinical Evaluation of Anti-Anginal January 1, 1989 Do Do Drugs Clinical Evaluation of Anti-Arrhythmic July 1, 1985 Do Do Drugs Clinical Evaluation of Drugs for the December 1, 1987 Do Do Treatment of Congestive Heart Failure Clinical Evaluation of Drugs for Do Do Ulcerative Colitis (3rd draft) Clinical Evaluation of Lipid-Altering September 1, 1990 Do Do Agents in Adults and Children Clinical Evaluation of Motility- Do Do Modifying Drugs Clinical Evaluation of Weight-Control October 1, 1997 Do Do Drugs Conducting a Clinical Safety Review of November 22, 1996 Do Do a New Product Application and Preparing a Report on the Review Developing Medical Imaging Drugs and October 13, 1998 Do Do Biologics Development and Evaluation of Drugs February 12, 1992 Do Do for the Treatment of Psychoactive Substance Use Disorders Evaluating Clinical Studies of February 18, 1997 Do Do Antimicrobials in the Division of Anti-Infective Drug Products Points to Consider for System Do Do Inflammatory Response Syndrome (SIRS) 1st Draft Points to Consider in the Preparation September 1, 1991 Do Do of IND Applications for New Drugs Intended for the Treatment of HIV- Infected Individuals Preclinical and Clinical Evaluation of April 1, 1994 Do Do Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis Submission of Abbreviated Reports and September 21, 1998 Do Do Synopses in Support of Marketing Applications Drug Metabolism/Drug Interaction April 7, 1997 Clinical pharmacology Do Studies in the Drug Development Process: Studies In Vitro Format and Content of the Human February 1, 1987 Do Do Pharmacokinetics and Bioavailability Section of an Application Pharmacokinetics and Pharmacodynamics May 15, 1998 Do Do in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling Population Pharmacokinetics February 10, 1999 Do Do General Considerations for Pediatric November 30, 1998 Clinical pharmacology o Pharmacokinetic Studies for Drugs and draft Biological Products In Vivo Metabolism/Drug Interaction November 19, 1998 Do Do Studies--Study Design, Data Analysis, and Recommendations for Dosing and Labeling A Review of FDA's Implementation of Compliance Do the Drug Export Amendments of 1986 Compressed Medical Gases December 1, 1989 Do Do Expiration Dating and Stability June 27, 1997 Do Do Testing of Solid Oral Dosage Form Drugs Containing Iron General Principles of Process May 1, 1987 Do Do Validation [[Page 31265]] Good Laboratory Practice Regulations Do Do Questions and Answers Monitoring of Clinical Investigations January 1, 1988 Do Do Nuclear Pharmacy Guideline Criteria May 1, 1984 Do Do for Determining When to Register as a Drug Establishment Sterile Drug Products Produced by May 1, 1987 Do Do Aseptic Processing Validation of Limulus Amebocyte Lysate December 1, 1987 Do Do Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Computerized Systems Used in Clinical June 18, 1997 Compliance draft Do Trials Investigating Out of Specification September 30, 1998 Do Do (OOS) Test Results for Pharmaceutical Production Manufacture, Processing or Holding of April 17, 1998 Do Do Active Pharmaceutical Ingredients Repackaging of Solid Oral Dosage Form February 1, 1992 Do Do Drug Products ANDAs: Impurities in Drug Products January 5, 1999 Generic drug draft Do ANDAs: Impurities in Drug Substances July 24, 1998 Do Do Content and Format of an Abbreviated April 18, 1997 Do Do New Drug Application (ANDA)--Positron Emission Tomography (PET) Drug Products--With Specific Information for ANDAs for Fludeoxyglucose F18 Injection Letter announcing that the OGD will August 18, 1995 Generic drug Do now accept the ICH long-term storage conditions as well as the stability studies conducted in the past Letter describing efforts of CDER & October 14, 1994 Do Do ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process Letter on incomplete Abbreviated April 8, 1994 Do Do Applications, 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 request for cooperation November 8, 1991 Do Do of regulated 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 provision of new July 1, 1992 Do Do information pertaining to new bioequivalence guidelines and refuse- to-file letters Letter on the provision of new March 15, 1989 Do Do procedures and policies affecting the generic drug review process Letter on the response to 12/20/84 March 26, 1985 Do Do letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act Letter to all ANDA and AADA applicants January 15, 1993 Do Do about the 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 August 4, 1993 Do Do interested parties about important detailed information regarding labeling scale-up, packaging, minor/ major amendment criteria, and bioequivalence requirements Organization of an Abbreviated New April 7, 1997 Do Do Drug Application and an Abbreviated Antibiotic Application Variations in Drug Products that May January 27, 1999 Do Do Be Included in a Single ANDA E5 Ethnic Factors in the Acceptability June 10, 1998 ICH draft guidances Do of Foreign Clinical Data efficacy [[Page 31266]] Q6A Specifications: Test Procedures November 25, 1997 ICH draft guidances-- Do and Acceptance Criteria for New Drug quality Substances and New Drug Products: Chemical Substances Q6B Specifications: Test Procedures June 9, 1998 Do Do and Acceptance Criteria for Biotechnological/Biological Products S4A Duration of Chronic Toxicity November 18, 1997 ICH draft guidances Do Testing in Animals (Rodent and safety Nonrodent Toxicity Testing) E1A The Extent of Population Exposure March 1, 1995 ICH guidances-- Do to Assess Clinical Safety: for Drugs efficacy Intended for Long-Term Treatment of Non-Life-Threatening Conditions E2A Clinical Safety Data Management: March 1, 1995 Do Do Definitions and Standards for Expedited Reporting E2B Data Elements for Transmission of January 15, 1998 Do Do Individual Case Reports E2C Clinical Safety Data Management: May 19, 1997 Do Do Periodic Safety Update Reports for Marketed Drugs E4 Dose-Response Information to November 9, 1994 Do Do Support Drug Registration E6 Good Clinical Practice: May 9, 1997 Do Do Consolidated Guideline E7 Studies in Support of Special August 2, 1994 Do Do Populations: Geriatrics E8 General Considerations for Clinical December 24, 1997 Do Do Trials E9 Statistical Principles for Clinical September 16, 1998 Do Do Trials M3 Nonclinical Safety Studies for the November 25, 1997 ICH guidances--joint Do Conduct of Human Clinical Trials for safety/efficacy Pharmaceuticals (multidisciplinary) Q1A Stability Testing of New Drug September 22, 1994 ICH guidances-- Do Substances and Products quality Q1B Photostability Testing of New Drug May 16, 1997 Do Do Substances and Products Q1C Stability Testing for New Dosage May 9, 1997 Do Do Forms Q2A Text on Validation of Analytical March 1, 1995 Do Do Procedures Q2B Validation of Analytical May 19, 1997 Do Do Procedures: 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 Biotechnological/Biological September 24, 1998 Do Do Pharmaceutical Products, Viral Safety Evaluation Q5B Quality of Biotechnology Products: February 23, 1996 Do Do Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Q5C Quality of Biotechnological July 10, 1996 Do Do Products: Stability Testing of Biotechnology/Biological Products Q5D Quality of Biotechnological/ September 21, 1998 Do Do Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products S1A The Need for Long-Term Rodent March 1, 1996 ICH guidances--safety Do Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity in February 23, 1998 Do Do Pharmaceuticals S1C Dose Selection for Carcinogenicity March 1, 1995 Do Do Studies of Pharmaceuticals S1C(R) Dose Selection for December 4, 1997 Do Do Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related Notes S2A Specific Aspects of Regulatory April 24, 1996 Do Do Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity: Standard Battery November 21, 1997 Do Do Testing S3A Toxicokinetics: The Assessment of March 1, 1995 Do Do Systemic Exposure in Toxicity Studies S3B Pharmacokinetics: Guidance for March 1, 1995 Do Do Repeated Dose Tissue Distribution Studies S5A Detection of Toxicity to September 22, 1994 Do Do Reproduction for Medicinal Products S5B Detection of Toxicity to April 5, 1996 Do Do Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility [[Page 31267]] S6 Preclinical Safety Evaluation of November 18, 1997 Do Do Biotechnology-Derived Pharmaceuticals E3 Structure and Content of Clinical July 17, 1996 IHC guidances-- Do Study Reports efficacy A Revision in Sample Collection Under July 15, 1996 Industry letters Do the Compliance Program Pertaining to Pre-Approval Inspections Certification Requirements for July 27, 1992 Do Do Debarred Individuals in Drug Applications Continuation of a series of letters June 1, 1990 Do Do communicating 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 April 10, 1987 Do Do informal notice about the Act, discussing the statutory mechanisms by which ANDA applicants may make modifications in approved drugs where clinical data is required Fourth of a series of letters October 31, 1986 Do Do providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I Implementation of the Drug Price October 11, 1984 Do Do Competition and Patent Term Restoration Act. Preliminary Guidance Implementation Plan USP injection October 2, 1995 Do Do nomenclature Instructions for Filing Supplements April 11, 1996 Do Do Under the Provisions of SUPAC-IR Seventh of a series of letters about July 29, 1988 Do Do the act providing guidance on the ``180-day exclusivity'' provision of section 505(j)(4)(B)(iv) of the FD&C Act Sixth of a series of informal notice April 28, 1988 Do Do letters about the Act discussing the 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 November 16, 1984 Do Do policies, procedures and implementation of the Act (Q & A format) Third of a series of letters regarding May 1, 1985 Do Do the implementation of the Act Regulatory Submissions in Electronic January 28, 1999 Information Do Format; General Considerations technology Regulatory Submissions in Electronic January 28, 1999 Do Do Format; New Drug Applications Acetaminophen, Aspirin and Codeine December 1, 1993 Labeling Do Phosphate Tablets/Capsules Acetaminophen and Codeine Phosphate December 1, 1993 Do Do Oral Solution/Suspension Acetaminophen and Codeine Phosphate December 1, 1993 Do Do Tablets/Capsules Alprazolam Tablets USP August 1, 1996 Do Do Amiloride Hydrochloride and September 1, 1997 Do Do Hydrochlorothiazide 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 Barbituate, Single Entity-Class March 1, 1981 Do Do Labeling Butalbital, Acetaminophen, Caffeine September 21, 1997 Do Do and Hydocodone Bitartrate Tablets Butalbital, Acetaminophen and Caffeine September 1, 1997 Do Do Capsules/Tablets USP Butorphanol Tartrate Injection USP October 1, 1992 Do Do Captopril and Hydrochlorothiazide April 1, 1995 Do Do Tablets USP Captopril Tablets February 1, 1995 Do Do Carbidopa and Levodopa Tablets USP February 1, 1992 Do Do Chlordiazepoxide Hydrochloride January 1, 1988 Do Do Capsules Cimetidine Hydrochloride Injection September 1, 1995 Do Do Cimetidine Tablets September 1, 1995 Do Do Cisapride Oral Suspension September 1, 1997 Do Do [[Page 31268]] Cisapride Tablets September 1, 1997 Do Do Clindamycin Phosphate Injection USP September 1, 1998 Do Do Clorazepate Dipotassium Capsules/ March 1, 1993 Do Do Tablets Combination Oral Contraceptives-- January 1, 1994 Do Do Physician and Patient Labeling Cyproheptadine Hydrochloride Tablets/ December 1, 1986 Do Do Syrup Diclofenac Sodium Delayed-Release January 1, 1997 Do Do Tablets Diltiazem Hydrochloride Extended- September 1, 1995 Do Do Release Capsules Diphenoxylate Hydrochloride and April 1, 1995 Do Do Atropine Sulphate Tablets USP Diphenoxylate Hydrochloride and April 1, 1995 Do Do Atropine Sulfate Oral Solution USP Dipivefrin Hydrochloride Ophthalmic October 1, 1998 Do Do Solution USP Dipivefrin Hydrochloride Ophthalmic November 2, 1998 Do Do Solution, 0.1% 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 April 1, 1992 Do Do and Solution USP Heparin Sodium Injection USP March 1, 1991 Do Do Hydrocodone Bitartrate and April 1, 1994 Do Do Acetaminophen Tablets USP Hydroxyzine Hydrochloride Injection December 1, 1989 Do Do Hypoglycemic Oral Agents--Federal April 1, 1984 Do Do Register Indomethacin Capsules USP September 1, 1995 Do Do Informal Labeling Guidance Texts for August 1, 1992 Do Do Estrogen Drug Products--Patient Labeling Informal Labeling Guidance Texts for August 1, 1992 Do Do Estrogen Drug 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 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, September 1, 1998 Do Do USP Metaproterenol Sulfate Inhalation May 1, 1992 Do Do Solution USP Metaproterenol Sulfate Syrup, USP May 1, 1992 Do Do Metaproterenol Sulfate Tablets May 1, 1992 Do Do Metoclopramide Tablets/ Oral Solution, February 1, 1995 Do Do USP Naphazoline Hydrochloride Ophthalmic March 1, 1989 Do Do Solution 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 September 1, 1997 Do Do Phendimetrazine Tartrate Capsules/ February 1, 1991 Do Do Tablets, and Extended-Release Capsules Phentermine Hydrochloride Capsules/ August 1, 1988 Do Do Tablets 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 November 1, 1993 Do Do Risperidone Oral Solution September 1, 1997 Do Do Risperidone Tablets September 1, 1997 Do Do Sulfacetamide Sodium Ophthalmic August 1, 1992 Do Do Solution/Ointment Sulfacetamide Sodium and Prednisolone January 1, 1995 Do Do Acetate Ophthalmic Suspension and Ointment Sulfamethoxazole and Phenazopyridine February 1, 1992 Do Do Hydrochloride Tablets Sulfamethoxazole and Trimethoprim August 1, 1993 Do Do Tablets and Oral Suspension Theophylline Immediate-Release Dosage February 1, 1995 Do Do Forms 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 [[Page 31269]] Verapamil Hydrochloride Tablets October 1, 1991 Do Do Vitamin A Capsules February 1, 1992 Do Do Zolpidem Tartrate Tablets September 1, 1997 Do Do Content and Format for Geriatric January 21, 1999 Labeling draft Do Labeling Non-Contraceptive Estrogen Class October 15, 1998 Do Do Labeling Non-Contraceptive Estrogen Drug January 8, 1999 Do Do Products--Physician and Patient Labeling OTC Topical Drug Products for the July 16, 1998 Do Do Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis) Therapeutic Equivalence Code Placement January 28, 1999 Do Do on Prescription Drug Labels and Labeling Enforcement Policy on Marketing OTC OTC Do Combination Products General Guidelines for OTC Combination Do Do Products Upgrading Category III Antiperspirants Do Do to Category I OTC Nicotine Substitutes March 1, 1994 OTC draft Do Points to Consider for OTC Actual Use July 22, 1994 Do Do Studies Format and Content of the Nonclinical February 1, 1987 Pharmacology/ Do Pharmacology/Toxicology Section of an toxicology Application Points to Consider in the Nonclinical Do Do Pharmacology/Toxicology Development of 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 February 1, 1989 Do Do Toxicity Studies of Antiviral Drugs Indicated for the Treatment of Non- Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies Single Dose Acute Toxicity Testing for August 26, 1996 Do Do Pharmaceuticals 180-Day Generic Drug Exclusivity Under July 14, 1998 Procedural Do the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act Advisory Committees: Implementing November 2, 1998 Do Do Section 120 of the Food and Drug Modernization Act of 1997 Enforcement Policy During November 23, 1998 Do Do Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act Fast Track Drug Development Programs: November 18, 1998 Do Do Designation, Development, and Application Review Implementation of Section 126, July 21, 1998 Do Do Elimination of Certain Labeling Requirements, of the FDA Modernization Act of 1997 National Uniformity for April 9, 1998 Do Do Nonprescription Drugs Ingredient Labeling for OTC Drugs Qualifying for Pediatric Exclusivity June 29, 1998 Do Do Under Section 505A of the Federal Food, Drug, and Cosmetic Act Repeal of Section 507 of the Federal June 15, 1998 Do Do Food, Drug, and Cosmetic Act Standards for the Prompt Review of May 15, 1998 Do Do Efficacy Supplements, Including Priority Efficacy Supplements Submitting Debarment Certification October 2, 1998 Procedural draft Do Statements Classifying Resubmissions in Response May 14, 1998 User fee Do to Action Letters Submitting and Reviewing Complete May 14, 1998 Do Do Responses to Clinical Holds ---------------------------------------------------------------------------------------------------------------- V. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN) [[Page 31270]] ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity or Internet) ---------------------------------------------------------------------------------------------------------------- Compliance Policy Guides Manual 1996 FDA regulated National Technical industries Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-920500) Compliance Programs Guidance Manual 1995 Do NTIS (Order No. PB95-915499) Inspection Operations Manual October 1994 Do NTIS (Order No. PB95-913399) Regulatory Procedures Manual August 1995 Do NTIS (Order No. PB95-265534) Requirements of Laws and Regulations 1997 Do Superintendent of Documents, Enforced by the U.S. Food and Drug Government Printing Office, Administration ``Blue Book'' Washington, DC 20402 FDA Recall Policy 1995 Do Industry Activities Staff (HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Action Levels for Poisonous or 1995 Food and animal feed Do Deleterious Substances in Human Food industries and Animal Feed Pesticides Analytical Manual 1994 Food Industry NTIS (Order No. PB94-911899) FDA Advisory for Deoxynivanol (DON) in September 16, 1993 Food and animal feed Office of Plant & Dairy Foods Finished Wheat Products Intended for industries & Beverages (HFS-306), Human Consumption and in Grain and CFSAN, Food and Drug Grain By-Products for Animal Feed Administration, 200 C St. SW., Washington, DC 20204, 202-205-4681 FDA's Cosmetic Labeling Manual October 1991 Cosmetic industry Office of Colors and Cosmetics (HFS-105), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4493 Statement of Policy: Foods Derived May 29, 1992 Developers of new Office of Premarket Approval from New Plant Varieties plant food varieties (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3100 A Food Labeling Guide September 1994 Food industry Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202- 512-1800 Appendix I--Model Small Business Food August 7, 1993 Do Industry Activities Staff Labeling Exemption Notice (HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5251 Food Labeling: Questions and Answers August 1993 Do Do Food Labeling: Questions and Answers: August 1995 Do Superintendent of Documents, Volume II Government Printing Office, Washington, DC 20420, 202- 512-1800 Fair Packaging and Labeling Act June 1978 Do NTIS (Order No. PB83-222117) Requirements and Interpretations Bacteriological Analytical Manual 7th 1992 FDA regulated AOAC International, 481 North Edition industries Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7077 FDA Food Importer's Guide for Low-Acid 1995 Food industry Industry Activities Staff Canned and Acidified Foods (HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5251 Fabrication of Single Service 1995 States Milk Safety Branch (HFS-626), Containers and Closures for Milk and CFSAN, Food and Drug Milk Products Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 Evaluation of Milk Laboratories 1995 Do Do Methods of Making Sanitation Ratings 1995 Do Do Of Milk Supplies Dry Milk Ordinance 1995 Do Do Procedures Governing the Cooperative 1995 Dairy industry Do State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers Frozen Dessert Processing Guidelines 1989 Do Office of Plant and Dairy Foods and Beverages (HFS- 302), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 Pasteurized Milk Ordinance 1995 States Milk Safety Branch (HFS-626), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 [[Page 31271]] FDA Nutrition Labeling Manual: A Guide 1993 Food industry Office of Food Labeling (HFS- for Developing and Using Databases 150), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 Guidelines for Determining Metric October 1, 1993 Do Do Equivalents of Household Measures List of Food Defect Action Levels 1995 Food and Animal Feed (DALS) Industries Industry Activities Staff (HFS-565), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5251 Action Levels for Poisonous or 1995 Do Do Deleterious Substances in Human Food and Feed (Also Found in CPG's) 1997 FDA Food Code 1997 States NTIS Seafood List 1993 Seafood industry Superintendent of Documents, Government Printing Office, Washington, DC 20402, 202- 512-1800 Manual of Operations National 1992 States Office of Seafood (HFS-407), Shellfish Sanitation Shellfish Sanitation Branch, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 Fish and Fisheries Products Hazards 1996 Seafood industry Office of Seafood (HFS-400), and Controls Guide Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 Guidance for Submitting Requests Under 1996 Food packaging Office of Premarket Approval 21 CFR 170.39, Threshold of industry (HFS-200), Food and Drug Regulation for Substances Used in Administration, 200 C St. Food Articles SW., Washington, DC 20204, 202-418-3100 Guidelines for the Preparation of 1996 Do Do Petition Submissions Guidelines for Approval of Color 1996 Color or contact lens Do Additives in Contact Lenses Intended industry as Colors Recommendations for Submission of February 1993 Color additives Do Chemical and Technological Data on industry Color Additives for Food, Drugs or Cosmetics Use Points to Consider for the Use of December 1992 Food packaging Do Recycled Plastics in Food Packaging: industry Chemistry Considerations Recommendations for Submission of May 1993 Do Do Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions Recommendations for Chemistry Data for June 1995 Do 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 September 1995 Food and food Do Additive and Chemical Contaminants in ingredient industry the Diet Toxicological Principles for the 1982 Petitioners for food NTIS (Order No. PR-83-170696) Safety Assessment of Direct Food or color additives Additives and Color Additives Used in Food (also known as Redbook I) Environmental Assessment Technical March 1987 Do NTIS (Order No. PB87-175345- Handbook AS, A-01) Preparing Environmental Assessments: August 1990 Do Office of Premarket Approval General Suggestions (HFS-200), Food and Drug Administration, 200 C St. SW, Washington, DC 20204, 202-418-3100 Step-by-Step Guidance for Preparing March 1987 Do Do Environmental Assessments Environmental Assessment of Food- February 1994 Do Do Packaging Materials with Enhanced Degradation Characteristics Color Additive Petitions Information 1996 Do Do and Guidance Toxological Testing of Food Additives 1983 Do Do [[Page 31272]] List of Products for Each Product October 8, 1992 Food industry Office of Food Labeling (HFS- Category 150), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561 Label Declaration of Allergenic June 10, 1996 Do Do Substances in Foods; Notice to Manufacturers Guidance on Labeling of Foods that February 24, 1997 Do Do Need Refrigeration by Consumers Interim Guidance on the Voluntary February 10, 1994 Do Do Labeling of Milk and Milk Products that Have Not Been Treated With Recombinant Bovine Somatropin Guidelines Concerning Notification and 1985 Infant formula Office of Special Testing of Infant Formula manufacturers Nutritionals (HFS-450), Food and Drug Administration, 200 C St. SW, Washington, DC 20204 202-205-4168 Clinical Testing of Infant Formulas 1985 Do Do with Respect to Nutritional Suitability for Term Infants Guidelines for the Evaluation of the Infants with 1988 Do Safety and Suitability of New Infant Allergic Diseases Formulas for Feeding Guidelines for the Evaluation of the 1990 Do Do Safety and Suitability of Infant Formulas for Feeding Infants with Allergic Diseases Guidelines for the Clinical Evaluation 1987 Do Do of New Products Used in the Dietary Management of Infants, Children and Pregnant Women with Metabolic Disorders Guidance Document for Arsenic (Trace January 1993 States Office of Seafood (HFS-400), Elements in Seafood) Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 or via Internet: FDA Home Page http://vm.cfsan.fda.gov/ list.html Guidance Document for Cadmium (Trace January 1993 Do Do Elements in Seafood) Guidance Document for Chromium (Trace January 1993 Do Do Elements in Seafood) Guidance Document for Lead (Trace August 1993 Do Do Elements in Seafood) Guidance Document for Nickel (Trace January 1993 Do Do Elements in Seafood) FDA's Policy for Foods Developed by 1995 Food industry Internet: FDA Home Page http:/ Biotechnology /vm.cfsan.fda.gov Bovine Spongiform Encephalopathy (BSE) 1997 Do Office of Plant and Dairy In Products for Human Use Foods and Beverages (HFS- 302), CFSAN, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175 or via Internet: FDA Home Page http://www.fda.gov/opacom/ morechoices/industry/ guidance/gelguide.htm Shellfish Sanitation Model Ordinance 1995 States Shellfish Program Implementation Branch, Office of Field Programs (HFS-628), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-8137 Draft Working Guide to Minimize 1998 Farmers and food Food Safety Initiative (HFS- Microbial Hazards for Fresh Fruits packers 3), Food and Drug and Vegetables Administration, 200 C. St. SW, Washington, DC 20204 or jsaltsman@bangate.fda.gov Iron-Containing Supplements and Drugs: 1997 Dietary supplement Office of Special Label Warning and Unit Dose manufacturers: small Nutritionals (HFS-450), Food Packaging; Small Entity Compliance entities and Drug Administration, 200 Guide C St. SW., Washington, DC 20204 Partial List of Enzyme Preparations 1998 FDA regulated Office of Premarket Approval That are Used in Foods industry (HFS-200), Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Partial List of Microorganisms and 1998 Do Do Microbial-Derived Ingredients That Are Used in Food [[Page 31273]] Fish and Fishery Products Hazards and January 1998 Do Office of Seafood (HFS-400), Controls Guide, 2nd Edition Food and Drug Administration, 200 C St. SW., Washington, DC 20204 HACCP Regulations for Fish and Fishery 1997 Do Do Products: Questions and Answers Notification of a Health Claim or 1998 Do Office of Food Labeling (HFS- Nutrient Content Claim Based on an 150), Food and Drug Authoritative Statement of a Administration, 200 C St. Scientific Body SW., Washington, DC 20204, 202-205-5099 Small Business Juice Labeling: 1998 Do Do Questions and Answers FDA Nutrition Labeling Manual, A Guide March 1998 Do Do for Developing and Using Data Bases HACCP Regulation for Fish and Fishery January 1999 Seafood processors Office of Seafood (HFS-400), Products: Questions and Answers, Food and Drug Issue Three, Revised Administration, 200 C St. SW., Washington, DC 20204, 202-418-3150 Foods--Adulteration Involving Hard or February 1999 FDA field offices Office of Plant and Dairy Sharp Foreign Objects (CPG) Foods and Beverages (HFS- 300), Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Food Additive Petition Expedited January 1999 FDA personnel and Office of Premarket Approval, Review regulated industry Food and Drug Administration, 200 C St. SW., 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 September 1998 FDA regulated Do--premarkt@cfsan.fda.gov OR Genes in Transgenic Plants industry http://vm.cfsan.fda.gov//dms/ opa-armg.html Changes to the ``Pesticides and December 30, 1998 FDA districts FOI/Domestic Programs Branch Industrial Chemicals in Domestic (HFS-636), Office of Field Foods'' Compliance Program for FY 99 Programs, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4771 FY 99 Mycotoxin Collection and Sample November 13, 1998 Do Do Analysis Schedule Revisions to the EHEC Method November 23, 1998 Do Do Vibrio Vulnificus and Vibrio June 17, 1998 Do Do parahaemolyticus in Retail Shell Oysters CFSAN Assignment 98-7 Revisions to Att F ``Special Survey September 30, 1998 Do Do Obligations--Dioxins and Furans in Food'' of the Pesticides and Industrial Chemicals Domestic Food Compliance Program for FY99 Collection and Analyses of Physical November 30, 1998 Do Do Sample to Support Undeclared Allergen Cases: NLEA and General Labeling Requirements; Domestic Compliance Program Assignment to Assure Unpasteurized September 21, 1998 Do Do Juice Manufacturers and Imported Juice Products Provide Required Label Warnings, Placards, and/or meet the 5 log Pathogen Reduction Requirement Assignment to Assure Unpasteurized November 3, 1998 Do Do Juice Manufacturers and Imported Juice Products Provide Required Label Warnings, Placards, and/or meet the 5 log Pathogen Reduction Requirement Pesticides in Imported Ginseng (Field September 17, 1998 FDA districts FOI/Imports Branch (HFS-606), Assignment) Office of Field Programs, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 Radionuclides in Foods October 2, 1998 Do Do Letters to Manufacturers of Prepared August 21, 1998 Manufacturers of Office of Field Programs (HFS- Sandwiches prepared sandwiches 600), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-5194 or JohnThomas@OFP@FDA.CFSAN, FAX 292-260-0133 ---------------------------------------------------------------------------------------------------------------- [[Page 31274]] VI. Guidance Documents Issued by the Center for Veterinary Medicine (CVM) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail Activity or Internet) ---------------------------------------------------------------------------------------------------------------- Guideline 3--General Principles for July 1994 Animal drug industry Internet via: http:// Evaluating the Safety of Compounds www.fda.gov/cvm or Used in Food-Producing Animals Communications Staff (HFV- 12), CVM, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, FAX 301- 594-1831 Guideline 4--Guidelines for Efficacy Do Do Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle Guideline 5--Stability Guidelines December 1990 Do Do Guideline 6--Guidelines for Submitting Do Do NADA's for Generic Drugs Reviewed by NAS/NRC Guideline 9--Preclearance Guidelines October 1975 Do Do for Production Drugs Guideline 10--Amendment of Section October 1975 Do Do II(G)(1)(b)(4) of the Preclearance Guidelines Guideline 13--Guidelines for January 1985 Do Do Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds Guideline 14--Guideline and Format for Do Do Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in FOOD Producing Animals Guideline 15--Guideline and Format for February 1977 Do Do Reporting the 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 Do Do Animal Feeds: Human Health Safety Criteria Guideline 19--Antibacterial Drugs in Do Do Animal Feeds: Animal Health Safety Criteria Guideline 20--Antibacterial Drugs in Do Do Animal Feeds: Antibacterial Effectiveness Criteria Guideline 22--Guideline Labeling of Do Do Arecoline Base Drugs Intended for Animal Use Guideline 23--Medicated Free Choice July 1985 Do Do Feeds--Manufacturing Control Guideline 24--Guidelines for Drug October 1983 Do Do Combinations for Use in Animals Guideline 25--Guidelines for the January 1979 Do Do Efficacy Evaluation of Equine Anthelmintics Guideline 29--Guidelines for the September 1980 Do Do Effectiveness Evaluation of Swine Anthelmintics Guideline 31--Guidelines for the July 1981 Do Do Evaluation of Bovine Anthelmintics Guideline 33--Target Animal Safety June 1989 Do Do Guidelines for New Animal Drugs Guideline 35--Bioequivalence 1996 Do Do Guideline--Final Guideline 36--Guidelines for Efficacy July 1985 Do Do Evaluation of Canine/Feline Anthelmintics Guideline 37--Guidelines for March 1984 Do Do Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation Guideline 38--Guideline for August 1984 Do Do Effectiveness Evaluation of Topical/ Otic Animal Drugs Guideline 40--Draft Guideline for the April 1992 Do Do Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry Guideline 41--Draft Guideline: June 1992 Do Do Formatting, Assembling, and Submitting New Animal Drug Applications Guideline 42--Animal Drug 1994 Do Do Manufacturing Guidelines, 1994 Guideline 43--Guidance on Generic October 1995 Do Do Animal Drug Products Containing Fermentation-Derived Drug Substances [[Page 31275]] Guideline 45--Guideline for Uniform August 1993 Do Do Labeling of Drugs for Dairy and Beef Cattle Guideline 48--Guidance for Industry November 1994 Do Do for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products Guideline 49--Guidance Document for April 1996 Do Do Target Animal Safety and Drug Effectiveness Studies for Anti- Microbial Bovine Mastitis Products Guideline 50--Draft Guideline for February 1993 Do Do Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products Guideline 52--Guidance-- January 1996 Do Do Microbiological Testing of Antimicrobial Drug Residues in Food Guideline 53--Guideline for the May 1994 Do Do Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals Guideline 54--Draft Guideline for June 1994 Do Do Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds Guideline 55--Supportive Data for Cat June 1994 Do Do Food Labels Bearing ``Reduces Urinary pH Claims: Guideline in Protocol Development'' Guideline 56--Protocol Development November 1994 Do Do Guideline for Clinical Effectiveness and Target Animal Safety Trials Guideline 57--Master Files--Guidance July 1995 Do Do for Industry for the Preparation and Submission of Veterinary Master Files Guideline 58--Guidance for Industry May 1997 Do Do for Good Target Animal Study Practices: Clinical Investigators and Monitors Guideline 59--Guidance for Industry: January 1999 Do Do Submitting a Notice of Claimed Investigational Exemption in Electronic Format to CVM via E-Mail Guidance 61--Guidance for Industry-- January 1999 Do Do FDA Approval of Animal Drugs for Minor Uses and for Minor Species Guideline 62--Guidance for Industry-- August 1997 Do Do Consumer-Directed Broadcast Advertisements Guideline 63--Guidance for Industry-- December 1997 Do Do Validation of Analytical Procedures: Definition and Terminology--Draft Guidance Guideline 64--Guidance for Industry-- December 1997 Do Do Validation of Analytical Procedures: Methodology--Draft Guidance Guideline 65--Guidance for Industry-- November 1997 Do Do Industry-Supported Scientific and Educational Activities Guideline 66--Guidance for Industry-- January 1998 Do Do Professional Flexible Labeling of Antimicrobial Drugs--Draft Guidance Guideline 67--Guidance for Industry-- February 1998 Do Do Small Entities Compliance Guide for Renderers Guideline 68--Guidance for Industry-- February 1998 Do Do Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors Guideline 69--Guidance for Industry-- February 1998 Do Do Small Entities Compliance Guide for Feeders of Ruminant Animals With On- Farm Feed Mixing Operations Guideline 70--Guidance for Industry-- February 1998 Do Do Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations Guideline 71--Guidance for Industry-- April 1998 Do Do Use of Human Chorionic Gonadotropic (HCG) as a Spawning Aid for Fish Guideline 72--Guidance for Industry-- May 1998 Do Do GMP's for Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDA [[Page 31276]] Guideline 73--Draft Guidance for July 1998 Do Do Industry--Stability Testing of New Animal Drug Substances and Products Guideline 74--Draft Guidance for July 1998 Do Do Industry--Stability Testing for New Dosage Forms of New Animal Drugs Guideline 75--Guidance for Industry-- July 1998 Do Do Stability Testing: Photostability Testing of New Animal Drug Substances and Products: Draft Guidance Guideline 76--Guidance for Industry-- July 1998 Do Do Questions and Answers--BSE Feed Regulation Guideline 77--Guidance for Industry-- August 1998 Do Do Interpretation of On-Farm Feed Manufacturing and Mixing Operations-- Draft Guidance Guideline 78--Guidance for Industry-- November 1998 Do Do Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals--Draft Guidance ---------------------------------------------------------------------------------------------------------------- VII. Guidance Documents Issued by the Office of Regulatory Affairs ---------------------------------------------------------------------------------------------------------------- How To Obtain A Hard Copy of Grouped by Intended The Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail, Activity 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 Medical Device August 27, 1998 Do Division of Compliance Policy Warning Letter Draft Pilot (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet www.fda.gov/ora/compliance-- ref/dev--pl.pdf Compliance Policy Guide-DRAFT January 5, 1998 Do Division of Compliance Policy Commercialization of In Vitro or via Internet at Diagnostic Devices (IVD's) Labeled www.fda.gov/cdrh/comp/ for Research Use Only or ivddrfg.html Investigational Use Only Compliance Policy Guide 675.400 (CPG November 13, 1998 Do Division of Compliance Policy 7126.24) REVISION Rendered Animal or via Internet at Feed Ingredients www.fda.gov/ora/compliance-- ref/cpg/cpgvet/ cpg675.400.html Compliance Policy Guide--DRAFT August 28, 1998 Do Division of Compliance Policy Distributor Medical Device Reporting or via Internet at www.fda.gov/ora/compliance-- ref/cpg--mdr3.txt Compliance Policy Guide 257.100 NEW December 21, 1998 Do Division of Compliance Policy Deferral of Source Plasma Donors Due or via Internet at to Red Cell Loss During Collection of www.fda.gov/ora/compliance-- Source Plasma by Automated ref/cpg/default.html Plasmapheresis FDA/ORA International Inspection May 1997 Do Division of Emergency & Manual and Travel Guide Investigational Operations (HFC-130), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 29857 or via Internet www.fda.gov/ora/ inspect--ref/itob/itob.html Glossary of Computerized System and August 1995 Do NTIS (Order No. PB96-127352) Software Development Terminology or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html [[Page 31277]] Import Alerts continuously Do Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 or via Internet www.fda.gov/ora/ fiars/ora--import-- alerts.html Investigations Operations Manual January 1999 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 or via Internet www.fda.gov/ora/inspect--ref/ iom/iomtc.html Investigations Operations Manual- July 1998 Do Do REVISION: Chapter 4--Sampling Investigations Operations Manual- July 1998 Do Do REVISION: Chapter 5--Establishment Inspection 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 Regulatory Procedures Manual August 1997 Do NTIS (Order No. PB97-196182) or via Internet www.fda.gov/ ora/compliance--ref/rpm/ rpmtc.html Regulatory Procedures Manual: UPDATE/ March 1998 Do Division of Compliance New Subchapter/ Application Integrity Policy, or via Internet Policy www.fda.gov/ora/compliance-- ref/rpm/rpmtc.html Regulatory Procedures Manual: UPDATE March 1998 Do Do Subchapter/Warning Letters Regulatory Procedures Manual: UPDATE/ April 1998 Do Do REVISION Subchapter/Import Procedures Regulatory Procedures Manual; UPDATE/ April 1998 Do Do REVISION Subchapter/Priority Enforcement Strategy for Problem Importers Regulatory Procedures Manual: UPDATE/ April 1998 Do Do REVISION Subchapter/Import Procedures Regulatory Procedures Manual: UPDATE/ April 1998 Do Do REVISION Subchapter/Notice of Sampling Regulatory Procedures Manual: UPDATE/ May 1998 Do Do NEW Subchapter/Granting and Denying Transportation and Exportation (T&E) Entries Regulatory Procedures Manual: UPDATE/ June 1998 Do Division of Compliance Policy REVISION Subchapter/Seizure or via Internet at www.fda.gov/ora/compliance-- ref/rpm--new2/ch6.html Regulatory Procedures Manual: UPDATE/ June 1998 Do Division of Compliance Policy REVISION Subchapter/Supervisory or via Internet at Charges www.fda.gov/ora/compliance-- ref/rpm--new2/ch9chgs.html Regulatory Procedures Manual: NEW July 1998 Do Division of Compliance Policy Subchapter/Civil Penalties-- or via Internet at Electronic Product Radiation Control www.fda.gov/ora/compliance-- ref/ch6civpen.html Guide to Inspections of Bulk May 1994 Do NTIS (Order No. PB96-127154) Pharmaceutical Chemicals or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Pharmaceutical July 1993 Do NTIS (Order No. PB96-127279) Quality Control Laboratories or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of July 1993 Do NTIS (Order No. PB96-127287) Microbiological Pharmaceutical or via Internet www.fda.gov/ Quality Control Laboratories ora/inspect--ref/igs/ iglist.html Guide to Inspections of Validation of July 1993 Do NTIS (Order No. PB96-127246) Cleaning Processes or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Lyophilization July 1993 Do NTIS (Order No. PB96-127253) of Parenterals or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of High Purity July 1993 Do NTIS (Order No. PB96-127261) Water Systems or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html [[Page 31278]] Guide to Inspections of Dosage Form October 1993 Do NTIS (Order No. PB96-127212) Drug Manufacturers-CGMPs or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Oral Solid January 1994 Do NTIS (Order No. PB96-127345) Dosage Forms Pre/Post Approval Issues or via Internet www.fda.gov/ for Development and Validation ora/inspect--ref/igs/ iglist.html Guide to Inspections of Topical Drug July 1994 Do NTIS (Order No. PB96-127394) Products or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Sterile Drug July 1994 Do NTIS (Order No. PB96-127295) Substance Manufacturers or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Oral Solutions August 1994 Do NTIS (Order No. PB96-127147) and Suspensions or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Nutritional February 1995 Do NTIS (Order No. PB96-127378) Labeling and Education Act (NLEA) or via Internet www.fda.gov/ Requirements ora/inspect--ref/igs/ iglist.html Guide to Inspections of Interstate April 1995 Do NTIS (Order No. PB96-127386) Carriers and Support Facilities or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Dairy Product April 1995 Do NTIS (Order No. PB96-127329) Manufacturers or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Miscellaneous May 1995 Do NTIS (Order No. PB96-127220) Foods Vol. I or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Miscellaneous September 1996 Do NTIS (Order No. PB97-196133) Foods Vol. II or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Low Acid November 1996 Do NTIS (Order No. PB97-196141) Canned Foods Manufacturers, Part 1 - or via Internet www.fda.gov/ Administrative Procedures/Scheduled ora/inspect--ref/igs/ Processes iglist.html Guide to Inspections of Low Acid April 1997 Do NTIS (Order No. PB97-196158) Canned Foods Manufacturers, Part 2- or via Internet www.fda.gov/ Processes/Procedures ora/inspect--ref/igs/ iglist.html Guide to Inspections of Cosmetic February 1995 Do NTIS (Order No. PB96-127238) Product Manufacturers or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Blood Banks September 1994 Do NTIS (Order No. PB96-127303) or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Source Plasma December 1994 Do NTIS (Order No. PB96-127360) Establishments or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Infectious June 1996 Do NTIS (Order No. PB96-199476) Disease Marker Testing Facilities or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Biotechnology Inspections Guide November 1991 Do NTIS (Order No. PB96-127402) or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Computerized February 1983 Do NTIS (Order No. PB96-127337) Systems in Drug Processing or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Foreign September 1995 Do NTIS (Order No. PB96-127311) Medical Device Manufacturers or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of Foreign May 1996 Do NTIS (Order No. PB96-199468) Pharmaceutical Manufacturers or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Mammography Quality Standards Act January 1998 Do NTIS (Order No. PB98-127178) (MQSA) Auditors Guide or via Internet www.fda.gov/ ora/inspect--ref/igs/ iglist.html Guide to Inspections of December 1997 Do NTIS (Order No. PB98-127152) Electromagnetic Compatibility Aspects or via Internet www.fda.gov/ of Medical Device Quality Systems ora/inspect--ref/igs/ iglist.html [[Page 31279]] Guide to Inspections of Grain Product March 1998 Do Division of Emergency and Manufacturers 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 February 1998 Do Do Inspections of In Vitro Devices Guide to Inspections of Viral March 1998 Do Do Clearance Processes for Plasma Derivatives Guide to Traceback of Fresh Fruits and August 1998 Do Do Vegetables Implicated in Epidemiological Investigations Guide to Inspections of Computerized August 1998 Do Do--Internet at www.fda.gov/ Systems in the Food Processing ora/inspect--ref/igf/ Industry iglist.html Guideline for the Monitoring of January 1988 FDA regulated Division of Compliance Policy Clinical Investigators industry (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 Computerized Systems Used in Clinical June 18, 1997 Do Do Trials-DRAFT Compliance Program 7348.808: Revised August 17, FDA staff personnel Do--Internet http:// Bioresearch Monitoring; Good 1998 www.fda.gov/ora/compliance-- Laboratory Practices (Nonclinical) ref/bimo/default.html Compliance Program 7348.810: Sponsors, Revised October Do Do Contract Research Organizations and 30, 1998 Monitors Compliance Program 7348.811: Revised September Do Do Bioresearch Monitoring; Clinical 2, 1998 Investigations Food Laboratory Practice Program October 1, 1991 Do Division of Compliance Policy (Nonclinical Laboratories) 7348.808A; EPA Data Audit Inspections Compliance Program 7348.809; August 18, 1994 Do Do Bioresearch Monitoring; Institutional Review Board Good Laboratory Practice Regulations August 1979 Do Do--Internet at www.fda.gov/ Management Briefings ora/compliance--ref/bimo/ default.html ---------------------------------------------------------------------------------------------------------------- VIII. Guidance Documents Issued by the Office of the Commissioner and Office of Policy ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Copy of Grouped by Intended the Document (Name and Name of Document Date of Issuance User or Regulatory Address, Phone, Fax, E-mail Activity or Internet ---------------------------------------------------------------------------------------------------------------- Draft Guidance for Industry; Exports June 1998 Regulated industry Internet via www.fda.gov/ and Imports under the FDA Export opacom/fedregister/ Reform and Enhancement Act of 1996 frexport.html FDA's Development, Issuance and Use of February 1997 FDA personnel and Internet via www.fda.gov/ Guidance Documents regulated industry opacom/morechoices/ moreindu.html or Office of Policy (301-827-3360) Industry Supported Scientific and December 1997 Regulated industry Internet via www.fda.gov/cder/ Educational Activities guidance/index.htm or Office of Policy (301-827-3360) Draft Guidance on Broadcast February 1997 Do Do Advertisements Direct Final Rule Guidance November 1997 FDA personnel Internet via www.fda.gov/ opacom/morechoices/industry/ guidedc.htm or Lisa Helmanis (301-443-3480) Small Entities Compliance Guide: February 1997 Regulated industry Internet via www.fda.gov/ Regulations to Restrict the Sale and opacom/campaigns/tobacco/ Distribution of Cigarettes and tobret.htm or 1-888-FDA- Smokeless Tobacco in Order to Protect 4KIDS Children and Adolescents (21 CFR Part 897) Children & Tobacco--Frequently Asked July 1997 Do Do Questions about the New Regulations (Draft) Children & Tobacco--A Retailer's Guide October 1997 Do Do to the New Federal Regulations Children & Tobacco--A Guide to the the October 1997 Do Do New Federal Regulations [[Page 31280]] FDA's Standards Policy October 1995 FDA personnel and 60 FR 53078, October 11, 1995 regulated industry or Office of Policy (301-827- 3360) Policy & Guidance Handbook for FDA 1994 FDA personnel National Technical Advisory Committees Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703- 487-4650 (Order No. PB94- 158854) ---------------------------------------------------------------------------------------------------------------- Dated: June 4, 1999. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 99-14752 Filed 6-9-99; 8:45 am] BILLING CODE 4160-01-F