[Federal Register: March 28, 2006 (Volume 71, Number 59)]
[Notices]
[Page 15422-15467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr06-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998N-0046]
Annual Comprehensive List of Guidance Documents at the Food and
Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual comprehensive list of all guidance documents currently in use at
the agency. This list is being published under FDA's good guidance
practices (GGPs) regulations. It is intended to inform the public of
the existence and availability of all of our current guidance
documents. It also provides information on guidance documents that have
been added or withdrawn in the past year.
DATES: We welcome general comments on this list and on agency guidance
documents at any time.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
For information on a specific guidance
or to obtain a hard copy of any of the guidances currently in use,
contact the appropriate Center listed in the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT: Regarding GGPs: Lisa Helmanis, Office
of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's GGPs were published in the Federal Register of September 19,
2000 (65 FR 56468), and became effective October 19, 2000. GGPs (Sec.
10.115 (21 CFR 10.115)) are intended to ensure involvement of the
public in the development of guidance documents, and to enhance
understanding of the availability, nature, and legal effect of such
guidance. In Sec. 10.115(n)(2), FDA stated that it intended to publish
an annual comprehensive list of guidance documents. The list in this
document updates a comprehensive list that published January 5, 2005
(70 FR 824).
This year FDA has adopted a new format for its annual comprehensive
guidance list. This new format is intended to increase the timeliness
of the annual comprehensive list. For information on a specific
guidance or to obtain a hard copy, please refer to the heading of each
Center's section (sections II through VIII of this document). The list
of guidance documents that have been withdrawn is for those guidances
that have been withdrawn from January 5, 2005, to January 5, 2006. The
list of current guidance documents is a printout of FDA's Web site as
of January 31, 2006 or February 1, 2006. You are encouraged to use
FDA's Web site as the most up-to-date source for all current guidance
documents in use by the agency, as the Web site is updated on a daily
basis.
In accordance with the agency's general policy on guidances, you
may comment on this list and on any FDA guidance document at any time.
We have organized the documents by the issuing Center or Office
within FDA. The dates in the list refer to the date we issued the
guidances or, where applicable, the last date we revised a document.
Because each issuing Center or Office maintains its own database, there
are slight variations in the way in which they provide the information
in this document.
II. Center for Biologics Evaluation and Research (CBER)
For information on a specific guidance document or to obtain a hard
copy, contact: Office of Communication, Training, and Manufacturers
Assistance, Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-
835-4709 or 301-827-1800, http://www.fda.gov/cber/guidelines.htm.
[[Page 15423]]
The following is a list of CBER guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
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Date of Date of
Title of Document Issuance Withdrawal
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Draft Guideline for the Validation of 9/28/1993 3/9/2005
Blood Establishment Computer Systems
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Draft Guidance for Reviewers: Premarket 8/3/2001 6/28/2005
Notification Submissions for Automated
Testing Instruments Used in Blood
Establishments
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Guidance for Industry: Discontinuation 5/6/2005 6/30/2005
of Donor Referral Related to Recent
Fever with Headache as a Symptom of
West Nile Virus Infection
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The following is a copy of the list of current CBER guidance
documents obtained from the FDA Web site on March 14, 2006.
CBER Guidance Documents (obtained from the FDA Web site on March 14, 2006)
2006
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines--3/2/
2006
Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza
Vaccines--3/2/2006
FDA Initiative Helps Expedite Development of Seasonal and Pandemic Flu Vaccines--3/2/2006
Guidance for Industry: Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130
of the Food and Drug Administration Modernization Act of 1997--2/15/2006
Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines
for Infectious Disease Indications--2/13/2006
Draft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support
Labeling Claims--2/2/2006
Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological
Products--Content and Format--1/18/2006
Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--
Content and Format--1/18/2006
Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling
for Human Prescription Drug and Biological Products--Content and Format--1/18/2006
Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products--Implementing the New
Content and Format Requirements--1/18/2006
Draft Guidance for Industry: INDs--Approaches to Complying with CGMP During Phase 1--1/12/2006
Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical
CGMP--1/11/2006
Guidance for Industry: Fast Track Drug Development Programs--Designation, Development, and Application Review--1/
11/2006
Appendix 2
Appendix 3--CDER MAPP 6020.3, CBER SOPP 8405
Appendix 4
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2005
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring
Committees--12/30/2005
FEDERAL REGISTER: Agency Information Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical
Trial Data Monitoring Committees--12/30/3005
Draft Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency--11/30/2005
Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps)--11/30/2005
Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing
Disease-Associated and Other Immunoglobulin (IgG) Antibodies--10/19/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E14 Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs--10/19/2005
International Conference on Harmonisation (ICH); Guidance for Industry: S7B Nonclinical Evaluation of the
Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals--10/19/
2005
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications--10/18/2005
International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4:
Organization of the CTD--10/18/2005
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and
Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices--
10/7/2005
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and
Modernization Act of 2002--Identification of Manufacturer of Medical Devices--6/19/2003
Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods--9/30/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management:
Data Elements for Transmission of Individual Case Safety Reports--9/30/2005
Draft Guidance for Industry: Using Electronic Means to Distribute Certain Product Information--9/29/2005
Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials--9/19/2005
Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited
Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User
Fee and Modernization Act of 2002--9/15/2005
Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act--9/7/2005
International Conference on Harmonisation (ICH); Draft Guideline: M5 Data Elements and Standards for Drug
Dictionaries--9/2/2005
[[Page 15424]]
Draft Guidance for Industry: Gene Therapy Clinical Trials--Observing Participants for Delayed Adverse Events--8/
23/2005
International Conference on Harmonisation (ICH); Draft Consensus Guideline: Q9 Quality Risk Management--8/5/2005
Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and
Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry--7/19/2005
Draft Guidance: Emergency Use Authorization of Medical Products--7/5/2005
FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache
as a Symptom of West Nile Virus Infection; Withdrawal of Guidance--6/30/2005
International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/
Biological Products Subject to Changes in Their Manufacturing Process--6/29/2005
FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions
for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance--6/28/2005
Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or
Suspected West Nile Virus Infection--6/23/2005
Draft Guidance for Industry: Bar Code Label Requirements--Questions and Answers--6/7/2005
Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients--5/18/2005
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in
Medical Devices--5/12/2005
Draft Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
Preventive Vaccine Clinical Trials--4/29/2005
Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies--4/27/2005
Guidance for Industry and FDA Staff: Application User Fees for Combination Products--4/20/2005
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Content of Labeling--4/20/2005
Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of
Premarket Review of a Combination Product--4/11/2005
Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics--4/1/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance Planning--3/31/
2005
Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products--3/30/2005
Guidance for Industry: Premarketing Risk Assessment--3/25/2005
Guidance for Industry: Development and Use of Risk Minimization Action Plans--3/25/2005
Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment--3/25/2005
Draft Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials--3/25/2005
Guidance for Industry: Pharmacogenomic Data Submissions--3/22/2005
Attachment to Guidance on Pharmacogenomic Data Submissions--3/22/2005
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions &
Answers and Change Requests--3/11/2005
Companion Document: Current Q&As and Change Requests--3/11/2005--Updated--7/18/2005--Updated--1/6/2006
International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical
Document Specification--4/1/2003
International Conference on Harmonisation (ICH) Guidance for Industry: E2B(M): Data Elements for Transmission of
Individual Case Safety Reports: Questions and Answers (Revision 2)--3/9/2005
FEDERAL REGISTER: Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of
Guidance--3/9/2005
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell
Separator Device Operating by Centrifugal or Filtration Separation Principle--3/9/2005
Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-
Forming Microorganisms--2/23/2005
Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications--2/17/
2005
Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications--12/27/1996
FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration;
Correction--2/11/2005
FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration--1/5/
2005
International Conference on Harmonisation (ICH); Draft Guidance on Q8 Pharmaceutical Development--2/8/2005
Draft Guidance for Industry: Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for
Labeling--2/7/2005
International Conference on Harmonisation (ICH); Draft Guidance on S8 Immunotoxicity Studies for Human
Pharmaceuticals--2/7/2005
Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing
User Fees--1/3/2005
----------------------------------------------------------------------------------------------------------------
2004
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD--Efficacy: Questions and
Answers (Revision 3)--12/22/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD--General: Questions and
Answers (Revision 3)--12/22/2004
Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices
Intended for Professional Use--11/30/2004
Guidance for Industry: Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Notice of extension of
application deadline--11/19/2004
Guidance for Industry: Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under PDUFA--10/6/2003
Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User
Fees Under MDUFMA--11/17/2004
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening
Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)--11/12/2004
Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)--11/8/2004
Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood
Cell Substitutes--10/28/2004
[[Page 15425]]
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and
Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the
Risk of Transmission of HIV-1 and HCV--10/21/2004
Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons
Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria--10/1/2004
Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and
Precautionary Information--10/1/2004
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing
Practice--9/29/2004
Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice
Regulations--9/29/2004
Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products--9/29/2004
Draft Guidance for Industry: Computerized Systems Used in Clinical Trials 9/29/2004
Guidance for Industry: Computerized Systems Used in Clinical Trials--5/10/1999
FEDERAL REGISTER--Annual Guidance Agenda--9/23/2004
Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator
Misconduct--9/2/2004
Guidance on Research Involving Coded Private Information or Biological Specimens--8/30/2004
Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification--8/20/
2004
Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols--8/18/2004
Guidance for Industry: Available Therapy--7/21/2004
Guidance for Industry: FDA Export Certificates (Corrected to update the Medical Devices contact phone number 4/
27/2005)--7/12/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Q1F Stability Data Package for
Registration Applications in Climatic Zones III and IV--7/2/2004
Guidance for Industry: Developing Medical Imaging Drug and Biological Products--6/17/2004
Part 1: Conducting Safety Assessments
Part 2: Clinical Indications
Part 3: Design, Analysis, and Interpretation of Clinical Studies
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD--Quality: Questions and
Answers/Location Issues--6/8/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data--6/7/
2004
International Conference on Harmonisation (ICH); Guidance for Industry: E5--Ethnic Factors in the Acceptability
of Foreign Clinical Data--Questions and Answers--6/3/2004
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s)--5/
28/2004
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions:
Effect on FDA Review Clock and Performance Assessment--5/20/2004
Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)--5/20/2004
Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance
Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for
Use in Screening Human Donors of Blood and Blood Components--4/23/2004
Draft Guidance for Industry: Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox
Vaccination--3/8/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data
Management: Periodic Safety Update Reports for Marketed Drugs--2/4/2004
International Conference on Harmonisation (ICH); Guidance for Industry: E2C Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs--11/1996
Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices--2/4/2004
Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements--2/4/2004
Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule)--2/4/
2004
Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule)
Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement--2/4/2004
Draft Guidance for Industry: ``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug
and Device Firms--2/4/2004
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions (Revision 1)--1/26/2004
Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions--3/18/2002
Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the
Treatment of Cancer (Revision 1)--1/16/2004
Draft Guidance for Industry: Drug Substance--Chemistry, Manufacturing, and Controls Information--1/6/2004
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2003
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Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater--12/17/2003
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components--12/
09/2003
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices--11/21/2003
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications--11/21/2003
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission--
11/21/2003
Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and
Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination
Products--3/12/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug
Substances and Products--11/20/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R) Impurities in New Drug Products--
11/13/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3C--Tables and List--11/12/2003
Guidance for Industry: Q3C Impurities: Residual Solvents--12/24/1997
Guidance for Industry: Product Recalls, Including Removals and Corrections--10/31/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review--10/31/2003
[[Page 15426]]
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the
Laboratory Diagnosis of West Nile Virus--10/30/2003
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations--10/
22/2003
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations--1/28/
1999
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect
on FDA Review Clock and Performance Assessment--10/8/2003
Guidance for Industry: Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track Products
Under PDUFA--10/6/2003
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion--9/22/2003
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety
in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS--9/16/2003
Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in
Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS--4/17/2003
Question and Answer on FDA Guidance Entitled ``Recommendations for the Assessment of Donor Suitability and
Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS)
or Exposure to SARS''--Since Publication of this guidance, CDC issued a health alert for travelers arriving
from Toronto Canada, and updated their case definition. As discussed in the guidance under section II.B.3.,
Updated Information on Case Definitions in Areas Affected by SARS, the FDA indicated that you should
consult with the CDC website and phone number for updates. Phone (888) 246-2675.
Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://www.cdc.gov/ncidod/
sars/casedefinition.htm.
ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting--
9/12/2003
Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry,
Manufacturing, and Controls Information--9/3/2003
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures--Scope and Application--9/3/2003
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug
Applications and Abbreviated New Drug Applications--8/27/2003
Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC)
Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)--8/15/2003
Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification--8/1/2003
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices--7/24/2003
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered
Questionnaires--7/3/2003
Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in
Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices--7/3/2003
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests
for Syphilis--6/25/2003
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic
Adverse Drug Experience Reports--6/23/2003
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations--6/19/2003
Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis,
and Impact on Dosing and Labeling--5/30/2003
Guidance for Industry: Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory
Applications--5/5/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review--5/1/2003
FEDERAL REGISTER--Annual Guidance Agenda--4/4/2003
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of
Xenotransplantation Products in Humans--4/3/2003
International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical
Document Specification--4/1/2003
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions &
Answers and Change Requests--3/11/2005
Companion Document: Current Q&As and Change Requests--3/11/2005--Updated--7/18/2005--Updated--1/6/2006
Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification--3/12/
2003
Draft Guidance for Industry; Comparability Protocols--Chemistry, Manufacturing, and Controls Information--2/20/
2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances--2/
11/2003
Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews--2/3/
2003
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD--Safety: Questions and
Answers--2/3/2003
Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information--1/28/2003
International Conference on Harmonisation (ICH); Guidance for Industry; Q1D Bracketing and Matrixing Designs for
Stability Testing of New Drug Substances and Products--1/15/2003
Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for
Therapeutics in Adult Healthy Volunteers--1/15/2003
Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood
Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox
VaccineRecipients--12/30/2002--(Corrected 2/4/2003)
Questions and Answers on FDA Guidance Entitled ``Recommendations for Deferral of Donors and Quarantine and
Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain
Contacts of Smallpox Vaccine Recipients''
----------------------------------------------------------------------------------------------------------------
2002
----------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for
FDA and Industry--10/3/2002
Guidance for Industry: Establishing Pregnancy Exposure Registries--9/20/2002--
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in
Humans and Animals--9/6/2002
Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)--6/14/2002
Guidance for Industry: Special Protocol Assessment--5/16/2002
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers--
5/13/2002
[[Page 15427]]
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry,
Manufacturing, and Controls Documentation--7/7/1999
Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public--5/2/2002--HHS Guideline
Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays
Used to Test Blood, Blood Components and Source Plasma Donations--4/10/2002
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational New Drug
Applications (INDs)--3/26/2002
Electronic IND Demo
Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation--3/
8/2002
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by
Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts--2/1/2002
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by
Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts--12/23/1999
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff--1/
11/2002
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products--1/9/2002
Questions and Answers on ''Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and
Blood Products''
----------------------------------------------------------------------------------------------------------------
2001
----------------------------------------------------------------------------------------------------------------
Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee
Act--11/21/2001
Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring
Committees--11/15/2001
Guidance for Industry--Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in
Cases of Possible Exposure to Anthrax--10/17/2001
International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document--10/16/2001--
M4: Organization of the CTD
M4E: The CTD--Efficacy
M4Q: The CTD--Quality
M4S: The CTD--Safety
M4S: The CTD--Safety Appendices
Guidance for Industry: Content and Format of Geriatric Labeling--10/5/2001
Guidance for Industry: Cancer Drug and Biological Products--Clinical Data in Marketing Applications--10/5/2001
International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients--9/25/2001
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format--General
Considerations--9/5/2001
Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays:
Special Controls--8/28/2001
Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and
Research--8/22/2001
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis--8/22/
2001
Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments--8/10/
2001
Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological
Products Other than Blood and Blood Components--8/10/2001
Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components
Intended for Transfusion or for Further Manufacture--8/7/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers--7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting
Devices)--7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and
Processing of Blood and Blood Components--7/19/2001
ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals--7/12/2001
Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k)
Cleared Bloodborne Pathogen Assays Used to Test Donors--7/11/2001
Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red
Blood Cells Obtained From An Outside Supplier--7/11/2001
Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls
Information--5/25/2001
Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--5/14/2001
ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials--5/11/2001
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited
Safety Reports--5/3/2001
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing--3/29/2001
Guidance for Industry: Financial Disclosure by Clinical Investigators--3/28/2001
Guidance for Industry: Acceptance of Foreign Clinical Studies--3/13/2001
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including
Vaccines--3/12/2001
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open
Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center
for Biologics Evaluation and Research--2/15/2001
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods--Technical
Correction February 2001--2/13/2001
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Prescription Drug
Advertising and Promotional Labeling--1/31/2001
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for
Transfusion--1/23/2001
PHS Guideline on Infectious Disease Issues in Xenotransplantation--1/19/2001
----------------------------------------------------------------------------------------------------------------
2000
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug Products: Chemical Substances--12/29/2000
[[Page 15428]]
International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal
Products in the Pediatric Population--12/15/2000
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and
601.27(a))--12/4/2000
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices--11/22/2000
Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised
Protocol--11/20/2000
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts--11/20/2000
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds--10/26/2000
Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral
Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral
Vectors--10/18/2000
Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-
Characterized, Therapeutic, Biotechnology-Derived Products--10/3/2000
Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies
of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products--11/1995
Draft Guidance for Industry: Analytical Procedures and Methods Validation--Chemistry, Manufacturing, and
Controls Documentation--8/30/2000
Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings--7/22/2000
Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment--6/28/
2000
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood
Specimens--6/23/2000
Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request--6/21/2000
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria--6/8/
2000
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components--
6/6/2000
Guidance for Industry: United States Industry Consensus Standard for the Uniform labeling of Blood and Blood
Components Using ISBT 128--11/1999
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing--3/15/2000
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products--3/7/2000
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level--3/7/2000
International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human
Use--2/10/2000
----------------------------------------------------------------------------------------------------------------
1999
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid
Sequences of Human Immunodeficiency Viruses Types 1 and 2--12/14/1999
Guidance for Industry: In Vivo Drug Metabolism / Drug Interaction Studies--Study Design, Data Analysis and
Recommendations for Dosing and Labeling--11/24/1999
REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and
Research (CBER) in Electronic Format--Biologics Marketing Applications [Biologics License Application (BLA),
Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)]--11/
12/1999, REVISED 11/22/1999
CBER Computer Assisted License Application (CALA) Questionnaire
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and
Cosmetic Act--10/8/1999
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications--9/13/
1999
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products--8/27/1999
ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological
Products--8/18/1999
Guidance for Industry: Consumer-Directed Broadcast Advertisements--8/6/1999
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics--8/3/1999
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations--7/24/1999
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended
for the Treatment of Osteoarthritis (OA)--7/15/1999
ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing);
Availability--6/25/1999
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine
and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus
(HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test
Results for Antibody to HCV (Anti-HCV)--6/17/1999
FEDERAL REGISTER Notice of Availability--6/22/1999
Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and
Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby
to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood
Recipients of Donor Test Results for Anti-HCV--9/23/1998
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for
Commercial Use--5/20/1999
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products--5/20/1999
Guidance for Industry For the 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 Form FDA 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for
Human Use''--5/10/1999
Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and
Establishment Description Information for an Allergenic Extract or Allergen Patch Test--4/23/1999
Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans--4/6/1999
Draft Guidance for Industry: Accelerated Approval Products--Submission of Promotional Materials--3/26/1999
Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional
Labeling--3/12/1999
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment
Description Information for a Biological In Vitro Diagnostic Product--3/8/1999
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description
Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products--2/17/1999
Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the
Treatment of Rheumatoid Arthritis (RA)--2/17/1999
Guidance for Industry: Population Pharmacokinetics--2/10/1999
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products--2/3/
1999
[[Page 15429]]
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment
Description Information for a Vaccine or Related Product--1/5/1999
----------------------------------------------------------------------------------------------------------------
1998
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and
Biological Products--11/30/1998
Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration
Modernization Act of 1997--10/30/1998
Draft Guidance for Industry: Submitting Debarment Certification Statements--10/2/1998
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal
Origin--9/24/1998
Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and
Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby
to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood
Recipients of Donor Test Results for Anti-HCV--9/23/1998
ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell
Substrates Used for Production of Biotechnological/Biological Products--9/21/1998
ICH Guidance on Statistical Principles for Clinical Trials--9/16/1998
Withdrawal of ``Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test
Results for Antibody to Hepatitis C Virus (Anti-HCV)''--Information Sheet--9/8/1998
Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for
Antibody to Hepatitis C Virus (Anti-HCV)--3/20/1998
Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1)--9/8/1998
Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications--7/27/1998
Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of
1997--Elimination of Certain Labeling Requirements--7/21/1998
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996--6/12/
1998
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing--
6/11/1998
ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data--6/10/1998
Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products--6/8/1998
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products--5/
15/1998
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy
Supplements--5/15/1998
Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis
and Impact on Dosing and Labeling--5/15/1998
Guidance for Industry: Classifying Resubmissions in Response to Action Letters--5/14/1998
Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for
Biologics Evaluation and Research--5/13/1998
Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients--4/17/1998
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy--3/30/1998
Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component
of the Stability Protocol for Sterile Products--1/28/1998
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the
Manufacture of Blood Products--1/8/1998
----------------------------------------------------------------------------------------------------------------
1997
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product
Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)--12/1997
Final Guidance on Industry-Supported Scientific and Educational Activities; Notice--12/3/1997
Guidance for FDA and Industry: Direct Final Rule Procedures--11/21/1997
Guidance for Industry: Industry-Supported Scientific and Educational Activities--11/1997
Guidance for Industry--The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine
Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use--10/07/1997
Guidance for Industry--Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological
Products: Clarification of What to Report--8/27/1997
Guidance for Industry--Donor Screening for Antibodies to HTLV-II--8/15/1997
Guidance for Industry--Screening and Testing of Donors of Human Tissue Intended for Transplantation--7/29/1997
Guidance for Industry--Changes to an Approved Application: Biological Products--7/24/1997
Guidance for Industry--Changes to an Approved Application for Specified Biotechnology and Specified Synthetic
Biological Products--7/24/1997
International Conference on Harmonisation (ICH) Guidance for Industry: Q2B Validation of Analytical Procedures:
Methodology--5/19/1997
International Conference on Harmonisation (ICH) Guidelines for the Photostability Testing of New Drug Substances
and Products--5/16/1997
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing
and Clinical Studies--4/10/1997
Proposed Approach to Regulation of Cellular and Tissue-Based Products--2/28/1997
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use--2/28/1997
Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description
for Autologous Somatic Cell Therapy Products--1/10/1997
----------------------------------------------------------------------------------------------------------------
1996
----------------------------------------------------------------------------------------------------------------
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic
Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use--8/1996
International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological
Products--7/10/1996
Guidance for Industry--The Content and Format for Pediatric Use Supplements--5/1996
Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for
Structural Repair or Reconstruction--5/1996
[[Page 15430]]
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic
Biotechnology-Derived Products--4/1996
International Conference on Harmonisation: Final Guideline on the Need for Long-Term Rodent Carcinogenicity
Studies of Pharmaceuticals--3/1996
International Conference on Harmonisation: Final Guideline on Quality of Biotechnical Products: Analysis of the
Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products--2/1996
----------------------------------------------------------------------------------------------------------------
1995 and earlier
----------------------------------------------------------------------------------------------------------------
Draft Reviewers' Guide: Disease Associated Antibody Collection Program--10/1/1995
Draft Reviewers' Guide: Informed Consent for Plasmapheresis / Immunization--10/1/1995
Guideline for Quality Assurance in Blood Establishments--7/11/1995 (NOTE: The text version does not contain
Tables 1-8)
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of
Biological Products--7/11/1995
Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic
Animals--1995
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic
Peptide Substance--11/1/1994
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for
Human and Veterinary Drug Products--11/1994
Guidance on Alternatives to Lot Release for Licensed Biological Products--7/14/1993
Draft Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)--7/12/1993
FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics--11/25/1992
Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologics Produced by
Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability--4/6/1992
Guideline for the Determination of Residual Moisture in Dried Biological Products--1/1/1990
Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease
Markers (``High Risk'' Donors)--10/26/1989
Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononeuclear Leukocytes for
Administering to Humans--8/22/1989
Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to
the Human Immunodeficiency Virus Type 1--8/8/1989
Revised Guideline for the Collection of Platelets, Pheresis--10/7/1988
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and
Animal Parenteral Drugs, Biological Products and Medical Devices--12/1987
Guideline on General Principles of Process Validation--5/1987
Guideline for the Uniform Labeling of Blood and Blood Components--8/1985
Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA
Technology--4/10/1985
Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for
Investigational Use in Humans--7/28/1983
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances--6/1980
----------------------------------------------------------------------------------------------------------------
III. Center for Drug Evaluation and Research (CDER)
For information on a specific guidance document or to obtain a hard
copy, contact: Division of Drug Information, Office of Training and
Communications, Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
4573,http://www.fda.gov/cder/guidance/index.htm.
The following is a list of CDER guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
------------------------------------------------------------------------
Preclinical Development of Antiviral 11/1/1990 7/6/2005
Drugs
------------------------------------------------------------------------
Conjugated Estrogens, USP: LC-MS Method 3/9/2000 8/12/2005
for Both Qualitative Chemical
Characterization and Documentation of
Qualitative Pharmaceutical Equivalence
------------------------------------------------------------------------
Phenytoin/Phenytoin Sodium Capsules, 3/4/1994 9/6/2005
Tablets and Suspension In Vivo
Bioequivalence and In Vitro
Dissolution Testing
------------------------------------------------------------------------
Organization of an Abbreviated New Drug 3/2/1999 11/18/2005
Application
------------------------------------------------------------------------
Preclinical Development of 9/4/1992 12/29/2005
Immunomodulatory Drugs for Treatment
of HIV Infection and Associated
Disorders
------------------------------------------------------------------------
The following is a copy of a list of current CDER guidance
documents obtained from the FDA Web site as of March 14, 2006.
CDER Guidance Documents (obtained from the FDA Web site on March 14, 2006)
FDA's Good Guidance Practices regulation of September 19, 2000.
Comprehensive List of Guidance Documents (updated 2/28/2006)
Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2006 (03/01/2006)
[[Page 15431]]
New/Revised/Withdrawn List for 2006 (updated 2/28/2006)
New/Revised/Withdrawn List for 2005 (updated 1/4/2006)
----------------------------------------------------------------------------------------------------------------
Advertising
----------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (Issued 12/
1997, Posted 1/12/1998)
Consumer-Directed Broadcast Advertisements (Issued 8/1999, Posted 8/6/1999)
Questions and Answers (Posted 8/6/1999)
Industry-Supported Scientific and Educational Activities (Issued 12/3/1997, Posted 12/4/1997)
----------------------------------------------------------------------------------------------------------------
Advertising Draft
----------------------------------------------------------------------------------------------------------------
Accelerated Approval Products: Submission of Promotional Materials (Posted 3/26/1999)
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Posted 2/4/2004)
Labeling Example
Labeling Example; Consumer-Friendly Version
Consumer-Directed Broadcast Advertising of Restricted Devices (Issued 1/26/2004, Posted 2/4/2004)
``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (Issued 1/
26/2004, Posted 2/4/2004)
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (Issued 1/1999, Posted 3/12/
1999)
Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare
Organizations or Pharmacy Management Companies (PBMs) (Issued 12/1997. Posted 1/5/1998)
----------------------------------------------------------------------------------------------------------------
Biopharmaceutics
----------------------------------------------------------------------------------------------------------------
Bioanalytical Method Validation (Issued 5/2001, Posted 5/22/2001)
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products--General Considerations (Issued
3/2003, Posted 3/19/2003)
Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance)
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 6/17/2005, Posted 6/17/2005)
Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posted 8/25/1997)
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
(Issued 9/1997, Posted 9/26/1997)
Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003)
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Issued 6/27/1989, Posted 3/2/1998)
Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing
(Revised 6/6/1994, Posted 6/22/1998)
Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001)
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based
on a Biopharmaceutics Classification System. (Issued 8/2000, Posted 8/31/2000)
----------------------------------------------------------------------------------------------------------------
Biopharmaceutics (Draft)
----------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/
2003)
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro
Bioequivalence Data (Posted 4/11/2003)
Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of
Qualitative Pharmaceutical Equivalence. Withdrawn per August 12, 2005, Federal Register notice.
----------------------------------------------------------------------------------------------------------------
CGMPs (Pharmaceutical CGMPs for the 21st Century)
----------------------------------------------------------------------------------------------------------------
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Issued 1/11/2006;
Posted 1/11/2006)
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (Posted 8/4/2004)
Part 11, Electronic Records; Electronic Signatures--Scope and Application (Posted 9/3/2003)
PAT--A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (posted 9/29/
2004)
Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice Posted 9/29/2004
----------------------------------------------------------------------------------------------------------------
CGMPs (Pharmaceutical CGMPs for the 21st Century)--Draft
----------------------------------------------------------------------------------------------------------------
Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls
Information (Posted 9/3/2003)
Current Good Manufacturing Practice for Combination Products (Posted 9/29/2004)
INDs--Approaches to Complying with CGMP's for Phase 1 Drugs (Issued 1/12/2006; Posted 1/12/2006)
Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment (Issued 11/
2003, Posted 11/6/2003)
Revised Attachments (Issued 11/2003, Posted 11/21/2003)
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Posted 9/29/2004)
----------------------------------------------------------------------------------------------------------------
Chemistry
----------------------------------------------------------------------------------------------------------------
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry,
Manufacturing, and Controls Documentation (Issued 2/2001, Posted 2/16/2001)
Botanical Drug Products (Issued 6/2004, Posted 6/9/2004)
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
(Issued 7/1997, Posted 7/28/1997)
Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004)
Changes to an Approved NDA or ANDA: Questions and Answers (Issued 1/2001, Posted 1/22/2001)
Changes to an Approved NDA or ANDA; Specifications--Use of Enforcement Discretion for Compendial Changes (Issued
11/19/2004, Posted 11/19/2004)
[[Page 15432]]
Container Closure Systems for Packaging Human Drugs and Biologics (Issued 5/1999, Posted 7/6/1999)
Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers (Issued 5/2002,
Posted 5/10/2002)
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived
Products
Development of New Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996)
Drug Master Files (9/1/1989)
Current DMF Information (e.g. lists, addresses, guidances, etc.)
Drug Master Files for Bulk Antibiotic Drug Substances (Issued 11/1999, Posted 11/26/1999)
Environmental Assessment of Human Drug and Biologics Applications (Issued 7/1998, Posted 7/24/98)
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* (Issued 2/1987,
Posted 3/2/1998)
Format and Content for the CMC Section of an Annual Report (9/1/1994)
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (Posted 5/20/2003)
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (Issued 5/2001,
Posted 6/4/2001)
Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001)
Nasal Spray and Inhalation Solution, Suspension, and Drug Products (Issued 7/2002, Posted 7/3/2002)
NDAs: Impurities in Drug Substances (Issued 2/2000, Posted 2/24/2000)
PAC-ATLS: Postapproval Changes--Analytical Testing Laboratory Sites (Issued 4/28/1998, Posted 4/28/1998)
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy
(BSE) (12/20/2000)
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
SUPAC-IR Questions and Answers about SUPAC-IR Guidance (2/18/1997)
SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum
(Issued 1/1999, Posted 2/25/1999)
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing,
and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/1997, Posted
10/6/1997)
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and
Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997; Posted 6/16/1997)
Reviewer Guidance, Validation of Chromatographic Methods
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug
Products
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances
Submitting Documentation for the Manufacturing of and Controls for Drug Products* (Issued 2/1987, Posted 3/2/
1998)
Submitting Documentation for the Stability of Human Drugs and Biologics* (Issued 2/1987, Posted 3/2/1998)
Submitting Samples and Analytical Data for Methods Validation
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
----------------------------------------------------------------------------------------------------------------
Chemistry (Draft)
----------------------------------------------------------------------------------------------------------------
Analytical Procedures and Methods Validation. (Issued 8/2000, Posted 8/30/2000)
Comparability Protocols--Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003)
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Posted 9/
11/2003)
Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2004, Posted 1/6/2004)
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (7/24/1999)
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (Issued 11/13/1998, Posted 11/19/1998,
Posted 9/27/1999)
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and
Labeling Documentation. (Issued 7/2002, Posted 8/20/2002)
Stability Testing of Drug Substances and Drug Products (Issued 6/5/1998, Posted 6/8/1998)
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (Issued 12/1998, Posted 1/5/1999)
----------------------------------------------------------------------------------------------------------------
Clinical/Antimicrobial
----------------------------------------------------------------------------------------------------------------
Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional
Approval (Issued 10/2002, Posted 10/31/2002)
Clinical Development and Labeling of Anti-Infective Drug Products (Issued 10/1992, Posted 3/2/1998, Revised 2/12/
2001)
Clinical Evaluation of Anti-Infective Drugs (Systemic) (Issued 9/77, Posted 3/2/1998)
----------------------------------------------------------------------------------------------------------------
Clinical/Antimicrobial (Draft)
----------------------------------------------------------------------------------------------------------------
Acute Bacterial Exacerbation of Chronic Bronchitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/
1998, Posted 7/22/1998)
Acute Bacterial Meningitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Acute Bacterial Sinusitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Acute or Chronic Bacterial Prostatitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/
22/1998)
Acute Otitis Media--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Antiviral Drug Development--Conducting Virology Studies and Submitting the Data to the Agency (Issued 5/24/2005,
Posted 5/24/2005)
Bacterial Vaginosis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Catheter-Related Bloodstream Infections--Developing Antimicrobial Drugs for Treatment (Issued 10/1999, Posted 10/
18/1999)
Community-Acquired Pneumonia--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Complicated Urinary Tract Infections and Pyelonephritis--Developing Antimicrobial Drugs for Treatment (Issued 7/
22/1998, Posted 7/22/1998)
Developing Antimicrobial Drugs--General Considerations for Clinical Trials (Issued 7/22/1998, Posted 7/22/1998)
Empiric Therapy of Febrile Neutropenia--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/
22/1998)
Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (2/18/1997)
Inhalational Anthrax (Post Exposure)--Developing Antimicrobial Drugs (Issued 3/15/2002, Posted 3/15/2002)
Lyme Disease--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Nosocomial Pneumonia--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (Issued 11/26/04, Posted 11/26/04)
Secondary Bacterial Infections of Acute Bronchitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/
1998, Posted 7/22/1998)
[[Page 15433]]
Streptococcal Pharyngitis and Tonsillitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998,
Posted 7/22/1998)
Uncomplicated and Complicated Skin and Skin Structure Infections--Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted 7/22/1998)
Uncomplicated Gonorrhea--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Uncomplicated Urinary Tract Infections--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/
22/1998)
Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox Vaccination (Posted 3/8/2004)
Vulvovaginal Candidiasis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
----------------------------------------------------------------------------------------------------------------
Clinical/Medical
----------------------------------------------------------------------------------------------------------------
Acceptance of Foreign Clinical Studies (Posted 3/12/2001)
Available Therapy (Posted 7/22/2004)
Calcium DTPA and Zinc DTPA Drug Products--Submitting a New Drug Application (Posted 8/13/2004)
Cancer Drug and Biological Products--Clinical Data in Marketing Applications (Posted 10/11/2001)
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid
Arthritis (RA) (Issued 1/1999, Posted 2/16/1999)
Clinical Development Programs for MDI and DPI Drug Products (Issued 9/19/1994, Posted 3/2/1998)
Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice)
Clinical Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)
Clinical Evaluation of Antianxiety Drugs (Issued 9/77, Posted 3/2/1998)
Clinical Evaluation of Antidepressant Drugs (Issued 9/77, Posted 3/2/1998)
Clinical Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Clinical Evaluation of Antiepileptic Drugs (adults and children) (Issued 1/1981, Posted 3/2/1998)
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per July 20, 2004, Federal Register
notice.)
Clinical Evaluation of General Anesthetics (Issued 5/1982, Posted 3/2/1998)
Clinical Evaluation of Hypnotic Drugs (Issued 9/77, Posted 3/2/1998)
Clinical Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Clinical Evaluation of Local Anesthetics (Posted 3/2/1998)
Clinical Evaluation of Psychoactive Drugs in Infants and Children (Posted 3/2/1998)
Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Collection of Race and Ethnicity Data in Clinical Trials (Issued 9/16/2005, Posted 9/16/2005)
Content and Format for Pediatric Use Supplements
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-
Characterized, Therapeutic, Biotechnology-derived Products
Developing Medical Imaging Drug and Biological Products
Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004)
Part 2: Clinical Indications (Issued 6/17/2004, Posted 6/17/2004)
Part 3: Design, Analysis, and Interpretation of Clinical Studies (Issued 6/17/2004, Posted 6/17/2004)
Development and Use of Risk Minimization Action Plans (Issued 3/24/2005, Posted 3/24/2005)
Establishing Pregnancy Exposure Registries (Issued 8/2002, Posted 9/20/2002)
Evaluating the Risks of Drug Exposure in Human Pregnancies (Issued 4/27/2005, Posted 4/27/2005)
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (Issued 12/1998, Posted 2/2/
1999, posted 9/14/1999)
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (Posted 3/2/1998)
FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal
Register notice.)
Format and Content of the Clinical and Statistical Sections of an Application (Issued 7/1988, Posted 5/21/1997)
Format and Content of the Summary for New Drug and Antibiotic Applications* (Issued 2/1987, Posted 3/2/1998)
Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Issued 2/1987, Posted 3/2/1998)
General Considerations for the Clinical Evaluation of Drugs
General Considerations for the Clinical Evaluation of Drugs in Infants and Children (Issued 9/77, Posted 3/2/
1998)
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (Issued 3/24/2005, Posted 3/24/2005)
Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (Posted 3/2/1998)
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug
and Biological Product Studies (Issued 1/2006)
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revised
1/15/2004, Posted 1/15/2004)
Internal Radioactive Contamination--Development of Decorporation Agents (Issued 3/1/2006, Posted 3/1/2006)
Integration of Dose-Counting Mechanisms into MDI Drug Products (Issued 3/2003, Posted 3/12/2003)
Levothyroxine Sodium Tablets--In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution
Testing (Issued 2/2001, Posted 3/8/2001)
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of
Ovarian Cancer (Posted 3/2/1998)
Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of
Colon and Rectal Cancer (Posted 3/2/1998)
Premarketing Risk Assessment (Issued 3/24/2005; Posted 3/24/2005)
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of
What to Report (Issued 8/27/1997, Posted 8/27/1997)
Postmarketing Reporting of Adverse Drug Experiences (Issued 3/1992, Posted 3/2/1998)
Preparation of Investigational New Drug Products (Human and Animal) (Issued 11/1992, Posted 3/2/1998)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/
14/1998)
Prussian Blue Drug Products--Submitting a New Drug Application (Issued 1/2003, Posted 2/4/2003)
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (Issued 7/22/1993, Posted 3/2/
1998)
Study of Drugs Likely to be used in the Elderly (Issued 11/1989, Posted 3/2/1998)
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1999, Posted 9/13/
1999)
[[Page 15434]]
The Use of Clinical Holds Following Clinical Investigator Misconduct
----------------------------------------------------------------------------------------------------------------
Clinical/Medical (Draft)
----------------------------------------------------------------------------------------------------------------
Acne Vulgaris: Developing Drugs for Treatment (Issued 9/16/2005, Posted 9/16/2005)
Allergic Rhinitis: Clinical Development Programs for Drug Products (Issued 6/2000, Posted 6/20/2000)
Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment (Issued 6/2000, Posted 6/27/2000)
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of
Osteoarthritis (Issued 7/07/1999, Posted 7/14/1999)
Clinical Evaluation of Lipid-Altering Agents (Issued 10/1990, Posted 2/18/1998)
Clinical Evaluation of Weight-Control Drugs (9/24/1996, Posted 2/18/1998)
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Issued 4/1/2005, Posted 4/1/2005)
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (Issued 5/2000, Posted 6/13/
2000)
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Issued 9/
6/2002)
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Symptoms--Recommendations for Clinical Evaluation (Issued 1/2003, Posted 1/30/2003)
Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children (Posted 11/6/
2001)
Exercise-Induced Bronchospasm (EIB)--Development of Drugs to Prevent EIB (Issued 2/2002, Posted 2/19/2002)
Exocrine Pancreatic Insufficiency Drug Products--Submitting NDAs (Posted 4/27/2004)
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment (Issued 5/2000, Posted 5/18/2000)
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Issued June 24, 2005, Posted June
27, 2005)
Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring
Committees (Issued 12/01/2005, Posted 2/07/2006)
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent
Requirements for Emergency Research (3/31/2000)
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (Issued 7/2002, Posted 7/25/2002)
OTC Treatment of Herpes Labialis with Antiviral Agents (Issued 3/8/2000, Posted 3/8/2000)
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Issued 2/2/
2006), Posted 2/2/2006)
Pediatric Oncology Studies In Response to a Written Request (Issued 6/2000, Posted 6/19/2000)
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
(Issued 4/1994, Posted 2/18/1998)
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (Posted 12/1/2000)
Systemic Lupus Erythematosus--Developing Drugs for Treatment (Issued 3/28/2005, Posted 3/28/2005)
----------------------------------------------------------------------------------------------------------------
Clinical Pharmacology
----------------------------------------------------------------------------------------------------------------
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (Issued 4/1997,
Posted 4/8/1997)
Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications (Posted 5/5/2003)
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application* (Issued 2/1987,
Posted 3/2/1998)
In Vivo Drug Metabolism/Drug Interaction Studies--Study Design, Data Analysis, and Recommendations for Dosing
and Labeling (Issued 11/24/1999, Posted 11/24/1999)
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
and Labeling (Posted 5/30/2003)
Pharmacokinetics in Patients with Impaired Renal Function (Issued 5/14/1998, Posted 5/14/1998)
Population Pharmacokinetics (Issued 2/1999, Posted 2/10/1999)
----------------------------------------------------------------------------------------------------------------
Clinical Pharmacology (Draft)
----------------------------------------------------------------------------------------------------------------
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (Issued 2/7/05, Posted
2/8/05)
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (Issued 11/1998,
Posted 11/12/1998)
Pharmacokinetics in Pregnancy--Study Design, Data Analysis, and Impact on Dosing and Labeling (Issued 10/29/
2004, Posted 10/29/2004)
----------------------------------------------------------------------------------------------------------------
Combination Products (Drug/Device/Biologic)
----------------------------------------------------------------------------------------------------------------
Draft and Final guidances can be found on the Office of Combination Products web site.
----------------------------------------------------------------------------------------------------------------
Compliance
----------------------------------------------------------------------------------------------------------------
A Review of FDA's Implementation of the Drug Export Amendments of 1986 (Issued 11/1989, Posted 3/2/1998)
Compressed Medical Gases (Issued 2/1989, Posted 3/10/1997)
Computerized Systems Used in Clinical Trials (Issued 4/1999, Posted 5/11/1999)
General Principles of Process Validation
Good Laboratory Practice Regulations Questions and Answers (Posted 3/2/1998)
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities--FDA Public Health Advisory (Issued and
Posted 4/5/2001)
Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal
Parenteral Drugs, Biological Products, and Medical Devices (Posted 3/2/1998)
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (Issued 6/27/1997,
Posted 6/27/1997)
Monitoring of Clinical Investigations (Posted 3/2/1998)
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Posted 3/2/1998)
Pharmacy Compounding--Compliance Policy Guide (Issued 5/2002, Posted 3/12/2004)
Possible Dioxin/PCB Contamination of Drug and Biological Products (Issued 8/23/1999, Posted 8/23/1999)
Prescription Drug Marketing Act--Donation of Prescription Drug Samples to Free Clinics (Issued 3/2006, Posted 3/
13/2006)
Street Drug Alternatives (Issued 3/2000, Posted 3/31/2000)
----------------------------------------------------------------------------------------------------------------
[[Page 15435]]
Compliance (Draft)
----------------------------------------------------------------------------------------------------------------
Bar Code Label Requirements--Questions and Answers. (Issued 6/7/2005, Posted 6/7/2005)
Computerized Systems Used in Clinical Trials (Posted 9/29/2004)
Current Good Manufacturing Practice for Medical Gases (Posted 5/6/2003)
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (5/27/2005)
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for
Emergency Research (21 CFR 50.24) Draft released for comment 3/30/2000 (5/12/2000)
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (Issued 9/30/1998, Posted 9/
30/1998)
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (Issued 4/17/1998, Posted 4/17/1998)
Marketed Unapproved Drugs--Compliance Policy Guide (Issued 10/15/2003, Posted 10/17/2003)
PET Drug Products--Current Good Manufacturing Practice (CGMP) (Issued 9/15/2005, Posted 9/15/2005)
----------------------------------------------------------------------------------------------------------------
Drug Safety
----------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Issued 2/
2005, Posted 2/2005)
----------------------------------------------------------------------------------------------------------------
Drug Safety Draft
----------------------------------------------------------------------------------------------------------------
FDA's ``Drug Watch'' for Emerging Drug Safety Information (Issued 5/5/2005; Posted 5/5/2005)
Questions and Answers (Qs & As)
----------------------------------------------------------------------------------------------------------------
Electronic Submissions
----------------------------------------------------------------------------------------------------------------
Part 11, Electronic Records; Electronic Signatures--Scope and Application (Posted 9/3/2003)
Providing Regulatory Submissions in Electronic Format--ANDAs (Issued 6/2002, Posted 6/27/2002)
Providing Regulatory Submissions in Electronic Format--Content of Labeling (Issued 4/20/2005, Posted 4/20/2005)
Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications. To ensure you have the most recent versions of the specifications
referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http:/ /www.fda.gov/cber/esub/esub.htm. For CDER, this Web site is http://www.fda.gov/cder/regulatory/ersr/ectd.htm.
r/regulatory/ersr/ectd.htm">http://www.fda.gov/cder/regulatory/ersr/ectd.htmder/regulatory/ersr/ectd.htm.
.
Regulatory Submissions in Electronic Format; General Considerations (Issued 1/1999, Posted 1/27/1999)
Regulatory Submissions in Electronic Format; New Drug Applications (Issued 1/1999, Posted 1/27/1999)
SPL Standard for Content of Labeling Technical Qs & As ( Issued 12/2005, Posted 12/8/2005)
Example of an Electronic New Drug Application Submission (Posted 2/17/1999).
----------------------------------------------------------------------------------------------------------------
Electronic Submissions Draft
----------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs (Posted 8/27/2003)
Providing Regulatory Submissions in Electronic Format--General Considerations (Issued 10/2003, Posted 10/22/
2003)
Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited Safety Reports (Issued 5/2001,
Posted 5/3/2001)
Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports
(Posted 6/23/3003)
Providing Regulatory Submissions in Electronic Format--Prescription Drug Advertising and Promotional Labeling
(Issued 1/2001, Posted 1/30/2001)
----------------------------------------------------------------------------------------------------------------
Generics
----------------------------------------------------------------------------------------------------------------
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (Issued 7/2003, Posted 7/31/2003)
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000)
ANDA's: Impurities in Drug Substances (Issued 11/1999, Posted 12/2/1999)
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act (Posted 3/27/2000)
Handling and Retention of BA and BE Testing Samples (5/25/2004)
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability
studies conducted in the past. (Posted 3/2/1998)
Letter describing efforts by the CDER and the 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 (Posted 3/2/1998)
Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for
Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD
Policy (Posted 3/2/1998)
Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file
letters (Posted 3/2/1998)
Letter on the provision of new procedures and policies affecting the generic drug review process (Posted 3/2/
1998)
Letter on the request for cooperation 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 (Posted 3/2/1998)
Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug
Price Competition and Patent Term Restoration Act (Posted 3/2/1998)
Letter to all ANDA and AADA applicants 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 (Posted 3/2/1998)
Letter to regulated industry notifying interested parties about important detailed information regarding
labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (Posted 3/2/1998)
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (Issued 12/2001, Posted 12/20/2001)
Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution
Testing (Issued 10/25/2005; Posted 10/25/2005)
Revising ANDA Labeling Following Revision of the RLD Labeling (Issued 4/26/2000, 4/26/2000)
Variations in Drug Products that May Be Included in a Single ANDA (Issued 12/1998, Posted 1/26/1999)
----------------------------------------------------------------------------------------------------------------
[[Page 15436]]
Generics (Draft)
----------------------------------------------------------------------------------------------------------------
ANDAs: Impurities in Drug Products (Issued 8/26/2005, Posted 8/26/2005)
ANDAs: Impurities in Drug Substances (Issued 1/28/2005, Posted 1/28/2005)
ANDAs: Pharmaceutical Solid Polymorphism (Issued 12/17/2004, Posted 12/17/2004)
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003--Questions and Answers (Issued 10/
2004, Posted 11/3/2004)
----------------------------------------------------------------------------------------------------------------
Good Review Practices (GRPs)
----------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Posted 2/
18/2005)
Pharmacology/Toxicology Review Format (Posted 5/9/2001)
----------------------------------------------------------------------------------------------------------------
Good Review Practices (GRPs) (Draft)
----------------------------------------------------------------------------------------------------------------
Industry Letters
----------------------------------------------------------------------------------------------------------------
Continuation of a series of letters 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
(Posted 3/2/1998)
Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by
which ANDA applicants may make modifications in approved drugs where clinical data is required (Posted 3/2/
1998)
Fourth of a series of letters providing informal notice to all affected parties about policy developments and
interpretations regarding the Act. Three year exclusivity provisions of Title I (Posted 3/2/1998)
Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance (Posted 3/2/
1998)
Implementation Plan USP injection nomenclature (Posted 3/2/1998)
Seventh of a series of letters about the Act providing guidance on the ``130-day exclusivity'' provision of
section 505(j)(4)(B)(iv) of the FD&C (Posted 3/2/1998)
Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of
sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act (Posted 3/2/1998)
Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) (Posted 3/
2/1998)
Third of a series of letters regarding the implementation of the Act (Posted 3/2/1998)
Year 2000 Letter from Dr. Janet Woodcock (10/19/98)
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation
----------------------------------------------------------------------------------------------------------------
Safety
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals
S1B Testing for Carcinogenicity of Pharmaceuticals (Issued 2/28/1998, Posted 3/24/1998)
S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals
S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and
Related Notes (Issued 12/4/1997, Posted 12/11/1997)
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (Issued 11/21/1997, Posted 5/
4/1998)
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) Posted 6/25/99
S5A Detection of Toxicity to Reproduction for Medicinal Products (Issued 9/1994, Posted 4/23/1997)
S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (Issued 11/1997, Posted 11/18/1997)
S7A Safety Pharmacology Studies for Human Pharmaceuticals (Issued 7/2001, Posted 7/12/2001)
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation)
by Human Pharmaceuticals (Issued 10/19/2005, Posted 10/19/2005).
Joint Safety/Efficacy (Multidisciplinary)
M2 eCTD: Electronic Common Technical Document Specification (Posted 4/1/2003)
M2: eCTD Specification Questions and Answers and Change Requests (Posted 3/14/05)
Companion Document: Current Q & As and Change Requests (Issued 1/6/2006; Posted 1/6/2006)
M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (Issued 11/1997,
Posted 11/25/1997)
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (Posted 10/15/2001)
M4: Organization of the CTD
M4 Granularity Annex (Issued 10/18/2005, Posted 10/18/2005)
M4: The CTD--General Questions and Answers (Issued 12/04, Posted 12/22/2004)
M4: The CTD--Quality
M4: The CTD--Quality Questions and Answers /Location Issues (Issued 6/2004, Posted 6/8/2004)
M4: The CTD--Efficacy
M4: The CTD--Efficacy Questions and Answers (Issued 12/2004, Posted 12/22/2004)
M4: The CTD--Safety
M4: The CTD--Safety Appendices
M4: The CTD--Safety Questions and Answers (Issued 2/2003, Posted 2/4/2003)
Efficacy
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of
Non-Life-Threatening Conditions
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case
Safety Reports (Issued 1/15/1998, Posted 1/15/1998)
E2BM Data Elements for Transmission Of Individual Case Safety Reports (Issued 4/2002, Posted 4/4/2002)
[[Page 15437]]
E2B(M) Questions and Answers (Revised 3/09/2005, Posted, 3/16/2005)
E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Issued 5/19/1997,
Posted 3/19/1998)
E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
(Posted 2/5/2004)
E2E Pharmacovigilance Planning (Issued 3/31/05; Posted 3/31/05)
E3 Structure and Content of Clinical Study Reports
E4 Dose-Response Information to Support Drug Registration
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data
E5 Questions and Answers (Issue 6/2004, Posted 6/4/2004)
E6 Good Clinical Practice: Consolidated Guideline Spanish Version (Issued 5/9/1997, Posted 3/19/1998)
E7 Studies in Support of Special Populations: Geriatrics
E8 General Considerations for Clinical Trials (Issued 12/1997, Posted 12/17/1997)
E9 Statistical Principles for Clinical Trials (9/1/1998)
E10 Choice of Control Group and Related Issues in Clinical Trials (Issued 5/2001, Posted 5/11/2001)
E11 Clinical Investigation of Medicinal Products in the Pediatric Population (Issued 12/2000, Posted 12/14/
2000)
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs (Issued 10/19/2005, Posted 10/19/2005)
----------------------------------------------------------------------------------------------------------------
Quality
----------------------------------------------------------------------------------------------------------------
Q1A(R2) Stability Testing of New Drug Substances and Products (Issued 11/2003, Posted 11/20/2003)
Q1B Photostability Testing of New Drug Substances and Products (Issued 11/1996, Reposted 7/7/1998)
Q1C Stability Testing for New Dosage Forms (Issued 5/9/1997, Posted 3/19/1998)
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (Issued 1/2003,
Posted 1/15/2003)
Q1E Evaluation of Stability Data (Issued 6/2004, Posted 6/7/2004)
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1 (7/1/2004)
Q2A Text on Validation of Analytical Procedures
Q2B Validation of Analytical Procedures: Methodology (Issued 5/19/1997, Posted 3/19/1997)
Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003)
Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003)
Q3C Impurities: Residual Solvents or Adobe Acrobat version (Issued 12/24/1997, Posted 12/30/1997)
Q3C Tables and List (Posted 11/12/2003)
Appendix 4, Appendix 5, and Appendix 6 (Appendices were issued with the Q3C draft guidance documents)
Maintenance Procedures for Updating (Posted 2/11/2002)
Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
(Posted 9/1998)
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of
r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used
for Production of Biotechnological/Biological Products; Availability (Issued 9/21/1998, Posted 9/21/1998)
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
(Issued 6/2005, Posted 6/29/2005)
Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug Products: Chemical Substances. (12/29/2000)
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Issued 8/
1999, Posted 12/14/2001)
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Issued 8/2001, Posted 9/24/
2001]
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (Draft)
----------------------------------------------------------------------------------------------------------------
Efficacy
E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
(Issued 9/30/2005, Posted 9/30/2005)
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (Posted 9/12/2003)
Principles for Clinical Evaluation of New Antihypertensive Drugs. (Issued 8/2000, Posted 8/8/2000)
Joint Safety/Efficacy (Multidisciplinary) (Draft)
International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug
Dictionaries (Issued 9/2005, Posted 9/2/2005)
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001,
Posted 9/5/2001)
Quality
Q8 Pharmaceutical Development (Issued 2/7/2005, Posted 2/8/2005)
Q9 Quality Risk Management (Issued 8/5/2005, Posted 8/5/2005)
Safety
S8 Immunotoxicity Studies for Human Pharmaceuticals (Issued 2/7/05, Posted 2/8/05)
----------------------------------------------------------------------------------------------------------------
Investigational New Drug Applications
----------------------------------------------------------------------------------------------------------------
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs
----------------------------------------------------------------------------------------------------------------
Labeling
----------------------------------------------------------------------------------------------------------------
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content and Format
(Issued 1/18/2006; Posted 1/18/2006)
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and Format
(Issued 1/18/2006; Posted 1/18/2006)
Content and Format for Geriatric Labeling (Issued 10/2001, Posted 10/4/2001)
----------------------------------------------------------------------------------------------------------------
[[Page 15438]]
Labeling (Draft)
----------------------------------------------------------------------------------------------------------------
Labeling for Combined Oral Contraceptives (Issued 3/2/2004, Posted 3/4/2004)
Labeling for Human Prescription Drug and Biological Products--Implementing the New Content and Format
Requirements (Issued 1/18/2006; Posted 1/18/2006)
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal
Candidiasis) (Issued 6/1998, Posted 7/20/1998)
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (Issued 11/15/2005,
Posted 11/15/2005)
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (Issued 10/2000, Posted
10/25/2000)
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug
and Biological Products--Content and Format (Issued 1/18/2006; Posted 1/18/2006)
----------------------------------------------------------------------------------------------------------------
Microbiology
----------------------------------------------------------------------------------------------------------------
Format and Content of the Microbiology Section of an Application*
----------------------------------------------------------------------------------------------------------------
Modernization Act of 1997
----------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004)
Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/
1998, Posted 11/20/1998)
Fast Track Drug Development Programs--Designation, Development, and Application Review (Posted 7/22/2004)
Appendix 2; Appendix 3 consisting of Mapp 6020.3 and SOPP 8405; and Appendix 4 [Appendices are scanned copies,
which will be replaced by final versions] (Issued 11/17/1998, Posted 11/17/1998)
Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000)
Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000)
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997--Advisory Committees
(Issued 10/1998, Posted 11/02/98)
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of
Certain Labeling Requirements (Issued 7/1998, Posted 7/20/98)
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002,
Posted 3/18/2002)
National Uniformity for Nonpresciption Drugs--Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/
14/1998)
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/
1999, Posted 10/4/1999)
Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric ``Rule,'' and Their Interaction
(Posted 7/27/1999)
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)
Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1998, Posted 9/15/
98)
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000
Women and Minorities Guidance Requirements (Issued 7/20/1998, Posted 11/25/1998)
----------------------------------------------------------------------------------------------------------------
Modernization Act of 1997 (Draft)
----------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004,
Posted 1/27/2004)
PET Drug Applications--Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)
Sample formats for chemistry, manufacturing, and controls sections
Sample formats for labeling
Sample formats for Form FDA 356h
Sample formats for user fee Form FDA 3397
Reports on the Status of Postmarketing Studies--Implementation of Section 130 of the Food and Drug
Administration Modernization Act of 1997 (Posted 4/4/2001)
----------------------------------------------------------------------------------------------------------------
Over-the-Counter (OTC) Guidances
----------------------------------------------------------------------------------------------------------------
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) (Posted 3/2/1998)
General Guidelines for OTC Combination Products (Posted 3/2/1998)
Labeling OTC Human Drug Products Using a Column Format (Issued 12/2000, Posted 12/18/2000)
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs
Example Drug Facts Labels
Acetaminophen 120 mg in a Suppository Dosage Form
Acetaminophen 325 mg in a Suppository Dosage Form
Acetaminophen 650 mg in a Suppository Dosage Form
Cimetidine 200 mg in a Tablet Dosage Form
Clemastine Fumerate 1.34 mg in a Tablet Dosage Form
Doxylamine Succinate 25 mg Tablet Dosage Form
Ibuprofen 200 mg in a Tablet/Capsule Dosage Form
Loperamide HCl in a Liquid Dosage Form
Loperamide HCl in a Tablet/Caplet Dosage Form
Miconazole Nitrate Vaginal Products
Minoxidil Topical Solution 2% for Men and Women
Minoxidil Topical Solution 5% for Men
Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form
Pseudoephedrine HCl Extended-Release Tablets 120 mg
[[Page 15439]]
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (Posted 3/2/1998)
----------------------------------------------------------------------------------------------------------------
Over-the-Counter (OTC) Draft
----------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products Questions and Answers (Issued 1/2005, Posted 1/12/05
Labeling OTC Human Drug Products--Submitting Requests for Exemptions and Deferrals (Issued 12/2000, Posted 12/18/
2000)
Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005)
Labeling OTC Human Drug Products Updating Labeling in ANDAs (2/21/2001)
Additional examples 1 (3/19/2001)
Additional examples 2 (3/26/2001)
Additional examples 3 (3/26/2001)
Time and Extent Applications (Issued 2/2004, Posted 2/11/2004)
----------------------------------------------------------------------------------------------------------------
Pharmacology/Toxicology
----------------------------------------------------------------------------------------------------------------
Carcinogenicity Study Protocol Submissions (Issued 5/22/2002)
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
Biotechnology-Derived Products
Developing Medical Imaging Drug and Biological Products
Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004)
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy
Volunteers (Issued 7/21/2005, Posted 7/21/2005.
Exploratory IND Studies (Issued 1/12/2006; Posted 1/12/2006)
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (Posted 3/2/1998)
Immunotoxicology Evaluation of Investigational New Drugs (Issued 10/2002, Posted 10/31/2002)
Nonclinical 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
Nonclinical Safety Evaluation of Pediatric Drug Products (Issued 2/14/2006, Posted 2/14/2006)
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Issued 05/18/2005, Posted 05/18/
2005)
Photosafety Testing (Posted 5/7/2003)
Recommended Approaches to Integration of Genetic Toxicology Study Results (Issued 1/3/2006, Posted 1/3/2006).
Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-
Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (Posted 3/2/1998)
Single Dose Acute Toxicity Testing for Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Pharmacology/Toxicology Draft
----------------------------------------------------------------------------------------------------------------
Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (Issued 11/
2001, Posted 11/9/2001)
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (Issued 6/17/2005; Posted
6/17/2005)
Nonclinical Safety Evaluation of Drug Combinations (Issued 1/26/05, Posted 1/26/05)
Safety Testing of Drug Metabolites (Issued 6/2005, Posted 6/3/2005)
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of
Pharmaceuticals (Issued 5/2001, Posted 5/7/2001)
----------------------------------------------------------------------------------------------------------------
Procedural
----------------------------------------------------------------------------------------------------------------
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
(Issued 6/1998, Posted 6/22/1998)
Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track Products Under PDUFA (Posted 10/1/
2003)
Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast
Track Products Under PDUFA (Posted 10/1/2003)
Paperwork Reduction Act Burden Statement (Posted 7/27/2004)
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act (Posted 3/27/2000)
Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings
Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (Issued 11/1999, Posted 11/
29/1999)
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate--Labeling Enforcement
Policy (Posted 6/3/2003)
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/
1998, Posted 11/20/1998)
Fast Track Drug Development Programs--Designation, Development, and Application Review (Posted 1/12/2006)
Appendix 2 ; Appendix 3 consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 [Appendices are scanned copies,
which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)
FDA Export Certicates (Issued 7/2004, Posted 7/13/2004)
Financial Disclosure by Clinical Investigators (3/27/2001)
Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000)
Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000)
Good Review Management Principles and Practices for PDUFA Products (Issued 3/2005; Posted 3/30/2005)
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations (Revised 6/
2003)
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997--Advisory Committees
(Issued 10/1998, Posted 11/02/98)
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of
Certain Labeling Requirements (Issued 7/1998, Posted 7/20/98)
Independent Consultants for Biotechnology Clinical Trial Protocols (Issued 8/18/2004, Posted 8/192/2004)
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002,
Posted 3/18/2002)
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001)
Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications
(Issued 7/2001, Posted 7/12/2001)
[[Page 15440]]
National Uniformity for Nonpresciption Drugs--Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)
Pharmacogenomic Data Submissions (Issued 3/2005, Posted 3/22/2005)
Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Issued 3/2005, Posted
3/22/2005)
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (Issued 12/2001, Posted 12/10/2001)
KI in Radiation Emergencies--Questions and Answers (Issued 12/20/2002, Posted 12/23/2002)
Potassium Iodide Tablets--Shelf Life Extension (Posted 3/8/2004)
Reduction of Civil Money Penalties for Small Entities (Issued 3/20/2001)
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/
1999, Posted 10/4/1999)
Refusal to File (Issued 7/12/1993, Posted 11/26/99)
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)
Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food and Drug
Administration Modernization Act of 1997 (Issued 2/15/2006; Posted 2/15/2006)
Special Protocol Assessment (Issued 5/2002, Posted 5/16/2002)
Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000)
----------------------------------------------------------------------------------------------------------------
Procedural Draft
----------------------------------------------------------------------------------------------------------------
Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999)
Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings
Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research,
Beginning on January 1, 2000 (Issued 12/1999, Posted 12/22/1999)
Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific
Advisory Committees (2/14/2002)
Emergency Use Authorization of Medical Products; Availability (Issued 7/5/2005; Posted 7/5/2005.
Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV (5/17/2004)
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (5/14/2001)
How to Comply with the Pediatric Research Equity Act (Posted 9/7/2005)
Independent Consultants for Biotechnology Clinical Trial Protocols (Posted 5/7/2003)
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004,
Posted 1/27/2004)
PET Drug Applications--Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)
Sample formats for chemistry, manufacturing, and controls sections
Sample formats for labeling
Sample formats for Form FDA 356h
Sample formats for user fee Form FDA 3397
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (Issued 3/2001, Posted
3/9/2001)
Submitting Debarment Certification Statements (Issued 10/2/98, Posted 10/2/98)
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted
9/5/2001)
The Use of Clinical Holds Following Clinical Investigator Misconduct (Issued 4/2002, Posted 8/26/2002)
Useful Written Consumer Medication Information (CMI) (Issued 5/25/2005, Posted 5/25/2005)
Using a Centralized IRB Review Process in Multicenter Clinical Trials (Issued 3/25/2005, Posted 3/25/2005)
----------------------------------------------------------------------------------------------------------------
Small Entity Compliance Guides
----------------------------------------------------------------------------------------------------------------
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation--Small Entity Compliance Guide (Posted
11/7/2001)
----------------------------------------------------------------------------------------------------------------
Small Entity Compliance Guides (Draft)
----------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005)
----------------------------------------------------------------------------------------------------------------
User Fees
----------------------------------------------------------------------------------------------------------------
Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (Issued 6/1999, Posted 6/25/99)
Guidance for Industry and FDA Staff: Application User Fees for Combination Products. (Issued 4/2005, Posted 5/3/
2005)
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001)
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (Issued 12/30/
2004, Posted 12/30/2004)
----------------------------------------------------------------------------------------------------------------
User Fees (Draft)
----------------------------------------------------------------------------------------------------------------
Attachment G--Draft Interim Guidance Document for Waivers of and Reductions in User Fees (7/16/1993)
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (Issued 4/15/2005, Posted 4/15/2005)
¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤¤
Also see Current Good Manufacturing Practice Regulations
Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations (Posted 8/11/1997)
----------------------------------------------------------------------------------------------------------------
IV. Center for Devices and Radiological Health (CDRH)
For information on a specific guidance document or to obtain a hard
copy, contact: Division of Small Manufacturers, International and
Consumer Assistance, Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 1-800-
638-2041 or 301-443-6597, http://www.fda.gov/cdrh/guidance.html.
The following is a list of CDRH guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
[[Page 15441]]
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
------------------------------------------------------------------------
Methods for Conducting Recall June 16, 1978 January 2006
Effectiveness Checks
------------------------------------------------------------------------
Guidance for Clinical Laboratory March 1, 2001 September 7,
Improvement Amendments of 1988 (CLIA) 2005
Criteria for Waiver; Draft Guidance
for Industry and FDA
------------------------------------------------------------------------
Guidance for Industry; In Vitro July 20, 1998 September 22,
Diagnostic C-Reactive Protein 2005
Immunological Test System
------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) July 22, 2000 September 7,
Ovulation Predictor 510(k)s 2005
------------------------------------------------------------------------
Draft Review Criteria for Nucleic Acid June 14, 1993 December 8,
Amplification Based In Vitro 2005
Diagnostic Devices for Direct
Detection of Infectious Microorganisms
------------------------------------------------------------------------
CDRH Interim Regulatory Policy for September 10, January 2005
External Penile Rigidity Devices 1997
------------------------------------------------------------------------
Guidance for Neurological Embolization November 1, January 2005
Devices 2000
------------------------------------------------------------------------
Class II Special Controls Guidance Draft of this Final issued
Document: Dental Bone Grafting document was on: April 28,
Material Devices issued on 2005
June 30, 2004
------------------------------------------------------------------------
Class II Special Controls Guidance Draft of this Final issued
Document: Vascular and Neurovascular document was on: December
Embolization Devices issued on 29, 2004
February 25,
2004
------------------------------------------------------------------------
Class II Special Controls Guidance Draft of this Final issued
Document: External Penile Rigidity document was on: December
Devices issued March 28, 2004
17, 2004
------------------------------------------------------------------------
The following is a copy of a list of current CDRH guidance
documents obtained from the FDA Web site as of March14, 2006.
CDRH Guidance Documents (obtained from the FDA Web site on March 14, 2006)
(1) A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for
Mammographic X-Ray Systems 979 03/01/1996
(2) Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic Products 951 08/01/1995
(3) Compliance Program for Field Compliance Testing of Cabinet X-Ray Equipment (CP 7386.004); Final Guidance for
Industry and FDA Staff 57 02/26/2001
(4) Compliance Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp Product Performance
Standard, as amended; Final Guidance for Industry and FDA 75 10/06/2001
(5) Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not
Substantially Equivalent (NSE) Letter--Guidance for Industry and FDA Staff 1544 11/08/2004
(6) Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 241 02/01/1975
(7) Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products;
Guidance for Industry and FDA 1412 07/12/2002
(8) Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for
Medical Use 399 09/01/1996
(9) Guide for Preparing Annual Reports for Ultrasonic Therapy Products 261 09/01/1996
(10) Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General) 243 10/01/
1987
(11) Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps 263 09/01/1995
(12) Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products 262 09/01/
1995
(13) Guide for Preparing Product Reports for Medical Ultrasound Products 960 09/01/1996
(14) Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only) 249 08/01/1996
(15) Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21-CFR 1002) 279 09/01/1995
(16) Guide for Preparing Reports on Radiation Safety of Microwave Ovens 239 03/01/1985
(17) Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21-
CFR 1002.10 235 04/01/1971
(18) Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21-CFR 1002.10 240
04/30/1974
(19) Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment
Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137) 254 09/01/1980
(20) Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21-CFR 1002.10 237
03/01/1973
(21) Information Requirements for Cookbooks and User and Service Manuals 697 10/31/1988
(22) Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160) 356 03/01/1990
(23) Laser Light Show Safety--Who's Responsibility (FDA 86-8262) 13 05/01/1986
(24) Laser Products--Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance for Industry and FDA
(Laser Notice 50) 1346 07/26/2001
(25) Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA
Performance Standards Exist 231 05/28/1981
(26) Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products 342 08/21/1986
(27) Quality Control Guide for Sunlamp Products (FDA 88-8234) 270 03/01/1988
(28) Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard 349 05/01/
1980
(29) Reporting and Compliance Guide for Television Products including Product Report, Supplemental Report,
Radiation Safety Abbreviated Report, Annual Report, Information and Guidance 260 10/01/1995
(30) Reporting Guide for Laser Light Shows and Displays (21-CFR1002) (FDA 88-8140) 251 09/01/1995
[[Page 15442]]
(31) Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002) 348 09/01/
1995
(32) Reporting of New Model Numbers to Existing Model Families 675 06/14/1983
(33) Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show
Products (replaces FDA 82-8127) 264 09/01/1995
(34) Suggested State Regulations for Control of Radiation--Volume II Nonionizing Radiation--Lasers (FDA Pub No.
83-8220) 70 01/01/1982
(35) Wireless Medical Telemetry Risks and Recommendations 1173 09/27/2000
(36) Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions,
Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and
FDA CBER 1201 02/25/2003
(37) Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002--Identification of
Manufacturer of Medical Devices--Draft Guidance for Industry and FDA Staff CBER 1217 06/23/2003
(38) Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for
Use in Humans and Animals CBER 09/06/2002
(39) Guidance for Industry: FDA Export Certificates CBER 1417 07/12/2004
(40) ``Help-Seeking'' and Other Disease Awareness Communications by or on behalf of Drug and Device Firms -
Draft Guidance for Industry CBER CDER CDRH 02/10/2004
(41) Bundling Multiple Devices or Multiple Indications in a Single Submission--Guidance for Industry and FDA
Staff CBER CDRH 1215 11/26/2003
(42) Expedited Review of Premarket Submissions for Devices--Guidance for Industry and FDA Staff CBER CDRH 108 11/
26/2003
(43) FY 2005 MDUFMA Small Business Qualification Worksheet and Certification--Guidance for Industry and FDA CBER
CDRH 2005 08/02/2004
(44) FY 2006 MDUFMA Small Business Qualification Worksheet and Certification--Guidance for Industry and FDA CBER
CDRH 2006 08/17/2005
(45) Guidance for Industry and FDA Staff--Use of Symbols on Labels and in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use CBER CDRH 4444 11/30/2004
(46) Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program
Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002--Gudiance for Industry,
FDA Staff, and FDA-Accredited Third-Parties CBER CDRH 1532 09/15/2005
(47) Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA--Guidance for
Industry and FDA Staff CBER CDRH 1303 11/17/2004
(48) User Fees and Refunds for Premarket Approval Applications--Guidance for Industry and FDA Staff CBER CDRH
1224 11/24/2003
(49) User Fees and Refunds for Premarket Notification Submissions (510(k)s)--Guidance for Industry and FDA Staff
CBER CDRH 1511 05/28/2004
(50) Acceptance of Foreign Clinical Studies; Guidance for Industry CDER 03/13/2001
(51) Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of
Osteoarthritis CDER 2199 07/07/1999
(52) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--General
Considerations CDER 10/22/2003
(53) Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds Developing Products for Treatment CDER 06/01/
2000
(54) Guidance for Industry; Collection of Race and Ethnicity Data in Clinical Trials CDER 09/01/2005
(55) Part 11, Electronic Records; Electronic Signatures--Scope and Application CDER 09/05/2003
(56) Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and
Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third Parties CDRH
1200 10/04/2004
(57) Alternative to Certain Prescription Device Labeling Requirements OC 1150 01/21/2000
(58) Civil Money Penalty Policy OC 1124 06/08/1999
(59) Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246) OC 10 03/01/
1995
(60) Color Additive Petitions (p. II-19 of PMA Manual) OC 296 06/01/1987
(61) Color Additive Status List (Inspection Operations Manual) OC 268 02/01/1989
(62) Commercial Distribution/Exhibit Letter OC 246 04/10/1992
(63) Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended--
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices--Draft Guidance for Industry and FDA
Staff OC 1217 10/11/2005
(64) Consumer-Directed Broadcast Advertising of Restricted Devices OC 1513 02/10/2004
(65) FDA Guide for Validation of Biological Indicator Incubation Time OC 283 01/01/1986
(66) General Principles of Software Validation; Final Guidance for Industry and FDA Staff OC 938 01/11/2002
(67) Guidance on Performance Standard for Lead Wires and Patient Cables OC 1197 03/09/1998
(68) Guideline for the Monitoring of Clinical Investigations OC 428 01/01/1988
(69) Implementation of the Biomaterials Access Assurance Act of 1998; Draft Guidance for Industry and FDA OC
1324 04/02/2001
(70) Letter to Medical Device Manufacturer on Pentium processors OC 456 02/14/1995
(71) Medical Device Tracking--Guidance for Industry and FDA Staff OC 169 05/05/2003
(72) Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236) OC
295 09/01/1989
(73) Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [Section 510(k)] [CPG 7124.19]
OC 181 09/24/1987
(74) Sterilized Convenience Kits for Clinical and Surgical Use; Final Guidance for Industry OC 1390 01/07/2002
(75) User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide;
Guidance for Industry OC 1212 04/01/2003
(76) Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects OC/
DBM 2229 03/19/1999
(77) Regulating In Vitro Diagnostic Device (IVD) Studies OC/DBM 1132 12/17/1999
(78) Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead
Wires and Patient Cables OC/DE1 1129 11/15/1999
(79) Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi) OC/DE1 545 05/17/1993
(80) All U.S. Condom Manufacturers, Importers and Repackagers OC/DE2 2510 04/07/1987
(81) Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all
Importers (Damaska Memo to Field on 4/8/87) OC/DE2 293 04/08/1987
(82) Dental Handpiece Sterilization (Dear Doctor Letter) OC/DE2 589 09/28/1992
(83) Draft Guidance for Industry on Surveillance and Detention Without Physical Examination of Condoms OC/DE2
1139 08/14/2000
(84) Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum
Levels of Exposure OC/DE2 1019 06/23/1978
[[Page 15443]]
(85) Hazards of Volume Ventilators and Heated Humidifiers OC/DE2 901 09/15/1993
(86) Latex Labeling Letter (Johnson) OC/DE2 831 03/18/1993
(87) Letter--Condom Manufacturers and Distributors OC/DE2 56 04/05/1994
(88) Letter--Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) OC/DE2
52 02/23/1994
(89) Letter--Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted
Disease Prevention (Holt) OC/DE2 53 02/13/1989
(90) Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson OC/DE2 869 05/10/1993
(91) Letter to Manufacturers/Repackers Using Cotton OC/DE2 101 04/22/1994
(92) Letter to Ophthalmologists about Lasers for Refractive Surgery OC/DE2 8323 06/27/1997
(93) Manufacturers and Initial Distributors of Hemodialyzers OC/DE2 2507 05/23/1996
(94) Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care
Professionals OC/DE2 933 02/03/1994
(95) Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid
Chemical Germicides with Medical Device Use Claims OC/DE2 851 06/30/1994
(96) Prospective Manufacturers of Barrier Devices used during Oral Sex for STD Protection OC/DE2 1394 10/31/1996
(97) Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy OC/DE2 1122 08/23/1996
(98) Standard Specification for Rubber Contraceptives (Condoms) OC/DE2 628 10/28/1983
(99) Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves;
Guidance for Industry--Draft OC/DE2 1141 07/26/2000
(100) Labeling for Male Condoms Made of Natural Rubber Latex--Class II Special Controls Guidance Document--Draft
Guidance for Industry and FDA Staff OC/DE2/OBGUB 1548 11/14/2005
(101) Computerized Devices/Processes Guidance--Application of the Medical Device GMP to Computerized Devices and
Manufacturing Processes OC/DE3 247 05/01/1992
(102) Design Control Guidance for Medical Device Manufacturers OC/DE3 994 03/11/1997
(103) Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals OC/DE3 1168 08/14/
2000
(104) Guidance for Industry: Labeling for Electronic Anti-Theft Systems OC/DE3 1170 08/15/2000
(105) Keeping Medical Devices Safe from Electromagnetic Interference OC/DE3 1081 07/01/1995
(106) Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance
for Industry and FDA OC/DE3 1392 07/30/2001
(107) Letter to Trade Association: ReUse of Single-use or Disposable Medical Devices OC/DE3 961 12/27/1995
(108) Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and Recommendations OC/DE3
1086
(109) Medical Devices and EMI: The FDA Perspective OC/DE3 1082 01/01/1995
(110) Quality Assurance Guidelines for Hemodialysis Devices OC/DE3 507 02/01/1991
(111) Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
OC/DE3 1140 02/03/2003
(112) Safety of Electrically Powered Products: Letter To Medical Device and Electronic Product Manufacturers
From Lillian Gill & BHB correction memo OC/DE3 1087 09/18/1996
(113) Unsafe Patient Lead Wires and Cables OC/DE3 889 09/03/1993
(114) Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
OC/DPO 1269 08/05/1999
(115) Inspection of Medical Device Manufacturers; Final Guidance for Industry and FDA OC/DPO/FPB 1702 02/07/2001
(116) Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a
Component of the Stability Protocol for Sterile Products OCD 01/28/1998
(117) FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and
Performance Assessment--Guidance for Industry and FDA Staff OCD 1218 10/08/2003
(118) FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and
Performance Assessment--Guidance for Industry and FDA Staff OCD 1219 05/21/2004
(119) Guidance for Industry: Financial Disclosure by Clinical Investigators OCD 03/20/2001
(120) Premarket Assessment of Pediatric Medical Devices--Guidance for Industry and FDA Staff OCD 1220 05/14/2004
(121) Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to use of the Medical
Devices Dispute Resolution Panel; Final Guidance for Industry and FDA OCD 1121 07/02/2001
(122) FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority
Provisions; Availability OCER 434 02/06/1998
(123) CDRH Manual for Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff OCER/DDUPSA 1323
02/09/2001
(124) Do It By Design--An Introduction to Human Factors in Medical Devices OCER/DDUPSA 995 12/01/1996
(125) Frequently Asked Questions about the Reprocessing and Reuse of Single Use Devices by Third Party and
Hospital Reprocessors; Final Guidance for Industry and FDA Staff OCER/DDUPSA 1333 07/06/2001
(126) Frequently Asked Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and
Hospital Reprocessors; Three Additional Questions--Guidance for Industry, FDA Staff, Third-Party and Hospital
Reprocessors OCER/DDUPSA 1427 07/16/2003
(127) Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and
Hospital Reprocessors: Three Additional Questions; Final Guidance for Industry and FDA Staff OCER/DDUPSA 1408
07/09/2002
(128) Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers OCER/DDUPSA
1128 04/19/2001
(129) Human Factors Points to Consider for IDE Devices OCER/DDUPSA 839 01/17/1997
(130) Human Factors Principles for Medical Device Labeling OCER/DDUPSA 227 09/01/1993
(131) Medical Device Reporting for User Facilities OCER/DDUPSA 989 04/01/1996
(132) Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management OCER/DDUPSA 1497
07/18/2000
(133) Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local
Agencies OCER/DMQRP 1071 08/13/1998
(134) Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) OCER/DMQRP 758
03/01/1989
(135) The Mammography Quality Standards Act Final Regulations Document 3 OCER/DMQRP 1496 07/18/2000
(136) The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance
Help System 11--Guidance for Industry, MQSA Inspectors, and FDA Staff OCER/DMQRP 1569 08/12/2005
(137) The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance
Help System 10--Guidance for Industry and FDA Staff OCER/DMQRP 1554 10/31/2005
(138) The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance
Help System 9--Draft Guidance for Industry and FDA OCER/DMQRP 1539 07/15/2005
[[Page 15444]]
(139) Guidance for Industry and FDA Staff--Exemption from Reporting and Recordkeeping Requirements for Low Power
Laser Products (Laser Notice 54) OCER/DMQRP OCER/DMQRP/EPDB 1592 01/06/2006
(140) A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film
Changers or Cassette Holders Intended for Diagnostic Use OCER/DMQRP/DDB 978 03/01/1996
(141) A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric Devices Intended
for Diagnostic Use OCER/DMQRP/DDB 977 03/01/1996
(142) A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major Components OCER/
DMQRP/DDB 257 01/01/1982
(143) Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-ray Equipment OCER/
DMQRP/DDB 1133 03/15/2000
(144) Guide for the Submission of Initial Reports on Computed Tomography X-Ray Systems OCER/DMQRP/DDB 271 12/01/
1985
(145) Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry
and FDA Staff OCER/DMQRP/DDB 2619 09/05/2003
(146) Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation
(PBL) Requirements in 21 CFR 1020.31(g) OCER/DMQRP/DDB 116 10/13/1993
(147) Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)--E.G.
Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems OCER/DMQRP/
EPDB 236 08/01/1995
(148) Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR
1040.30)--Guidance for Industry and FDA Staff OCER/DMQRP/EPDB 1565 11/06/2005
(149) Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device OCER/DMQRP/
EPDB 903 03/01/1987
(150) Compliance Guide for Laser Products (FDA 86-8260) OCER/DMQRP/EPDB 278 09/01/1985
(151) Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers OCER/
DMQRP/EPDB 343 09/16/1981
(152) Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven
Compliance Survey Instruments (FDA 88-8264)] OCER/DMQRP/EPDB 286 03/01/1988
(153) Guide for Preparing Product Reports for Lasers and Products Containing Lasers OCER/DMQRP/EPDB 277 09/01/
1995
(154) Guide for the filing of Annual Reports for X-Ray Components and Systems OCER/DMQRP/EPDB 253 07/01/1980
(155) Imports Radiation-Producing Electronic Products (FDA 89-8008) OCER/DMQRP/EPDB 756 11/01/1988
(156) Letter to All Manufacturers and Importers of Microwave Ovens: Retention of Records Required by 21 CFR 1002
OCER/DMQRP/EPDB 880 08/24/1981
(157) Open Door Operation of Microwave Ovens as a Result of Oven Miswiring OCER/DMQRP/EPDB 646 03/28/1980
(158) Policy on Lamp Compatibility (sunlamps) OCER/DMQRP/EPDB 2343 09/02/1986
(159) Policy on Warning Label Required on Sunlamp Products OCER/DMQRP/EPDB 1343 06/25/1985
(160) Procedures for Laboratory Compliance Testing of Television Receivers OCER/DMQRP/EPDB 945 05/01/1986
(161) Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance
for Industry and FDA--Laser Notice 51 OCER/DMQRP/EPDB 1349 05/27/2001
(162) Compliance Guidance--The Mammography Quality Standards Act Final Regulations: Preparing For MQSA
Inspections; Final Guidance for Industry and FDA OCER/DMQRP/ICB 6400 11/05/2001
(163) Guidance for Industry and FDA Staff--Mammography Facility Surveys, Mammography Equipment Evaluations, and
Medical Physicist Qualification Requirements under MQSA OCER/DMQRP/ICB 6409 09/13/2005
(164) 510(k) Manual--Premarket Notification: 510(k)--Regulatory Requirements for Medical Devices OCER/DSMICA 469
08/01/1995
(165) Certification Statement for the Impact Resistance Test OCER/DSMICA 1460 10/25/1993
(166) Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC
Q9001 and ISO/DI 13485:1996 OCER/DSMICA 133
(167) DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and
the USA: Confidence Building Program: Overview, Medical Device Annex, Version 7 June 29, 2000 OCER/DSMICA 1396
(168) DRAFT Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and
the USA: Confidence Building Program: Procedures, Medical Device Annex, Version 7 June 29, 2000 OCER/DSMICA
1397
(169) Draft Medical Glove Guidance Manual OCER/DSMICA 852 07/30/1999
(170) Guidance for Staff, Industry and Third 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) OCER/DSMICA 1114 01/06/1999
(171) Impact Resistant Lenses: Questions and Answers (FDA 87-4002) OCER/DSMICA 23 09/01/1987
(172) Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff,
Industry and Third Parties OCER/DSMICA 1160 02/02/2001
(173) In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions OCER/DSMICA 471 01/01/1997
(174) Labeling--Regulatory Requirements for Medical Devices (FDA 89-4203) OCER/DSMICA 470 09/01/1989
(175) Medical Device Appeals and Complaints: A Guidance on Dispute Resolution OCER/DSMICA 396 02/19/1998
(176) Medical Device Quality Systems Manual: A Small Entity Compliance Guide OCER/DSMICA 6303 12/01/1996
(177) Medical Device Reporting for Manufacturers OCER/DSMICA 987 03/01/1997
(178) Overview of FDA Modernization Act of 1997, Medical Device Provisions OCER/DSMICA 1174 02/19/1998
(179) Regulation of Medical Devices: Background Information for International Officials OCER/DSMICA 610 04/14/
1999
(180) D95-2, Attachment A (Interagency Agreement between FDA & HCFA) ODE 2106 09/15/1995
(181) D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA) ODE 3106 09/15/
1995
(182) 30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for
Industry and CDRH (Docket 98D-0080); Final ODE 795 02/19/1998
(183) 510(k) Additional Information Procedures K93-1 (blue book memo) ODE 886 07/23/1993
(184) 510(k) Quality Review Program (blue book memo) ODE 344 03/29/1996
(185) 510(k) Refuse to Accept Procedures K94-1 (blue book memo) ODE 401 05/20/1994
(186) 510(k) Sign-Off Procedures K94-2 (blue book memo) ODE 308 06/03/1994
(187) A New 510(k) Paradigm--Alternate Approaches to Demonstrating Substantial Equivalence in Premarket
Notifications ODE 905 03/20/1998
(188) A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance
for Industry and FDA Staff ODE 1347 11/10/2005
(189) A Suggested Approach to Resolving Least Burdensome Issues ODE 1188 09/11/2000
[[Page 15445]]
(190) Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile
Devices ODE 267 12/01/1983
(191) Assignment of Review Documents I90-2 (blue book memo) ODE 366 08/24/1990
(192) Availability of Information Given to Advisory Committee Members in Connection with CDRH Open Public Panel
Meetings; Draft Guidance for Industry and FDA Staff ODE 1341 07/18/2001
(193) Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept
Policy ODE 4859 06/30/1993
(194) Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy--
(updated Checklist 3/14/1995) ODE 3859 06/30/1993
(195) Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and
CDRH Staff ODE 1337 05/29/2001
(196) Classified Convenience Kits ODE 789 04/30/1993
(197) Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related
Measurement Devices G90-2 (blue book memo) ODE 30 10/19/1990
(198) Consolidated Review of Submissions for Lasers and Accessories G90-1 (blue book memo) ODE 31 10/19/
1990
(199) Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1) ODE
872 07/15/1996
(200) Convenience Kits Interim Regulatory Guidance ODE 562 05/20/1997
(201) Cover Letter: 510(k) Requirements 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 K95-1) ODE 406 11/21/1995
(202) Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1) ODE 935 01/10/1997
(203) Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final
Guidance for FDA Reviewers and Industry ODE 1073 11/30/2000
(204) Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff ODE 857 12/03/2002
(205) Device Labeling Guidance G91-1 (blue book memo) ODE 414 03/08/1991
(206) Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data Packages ODE 563 10/
10/1997
(207) Document Review Processing I91-1 (blue book memo) ODE 446 02/12/1992
(208) Documentation and Resolution of Differences of Opinion on Product Evaluations G93-1 (blue book
memo) ODE 920 12/23/1993
(209) Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for
CDRH Staff ODE 310 02/28/2001
(210) Format for IDE Progress Reports ODE 311 06/01/1996
(211) Frequently Asked Questions on the New 510(k) Paradigm; Final ODE 2230 10/22/1998
(212) Goals and Initiatives for the IDE Program D95-1 (blue book memo) ODE 405 07/12/1995
(213) Guidance for Industry; General/Specific Intended Use; Final ODE 499 11/04/1998
(214) Guidance for Off-the-Shelf Software Use in Medical Devices; Final ODE 585 09/09/1999
(215) Guidance for Submitting Reclassification Petition ODE 609 01/01/1997
(216) Guidance on Amended Procedures for Advisory Panel Meetings; Final ODE 413 07/22/2000
(217) Guidance on IDE Policies and Procedures; Final ODE 882 01/20/1998
(218) Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies--for Use by CDRH
and Industry; Final ODE 322 02/19/1998
(219) Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 ODE 1135 08/09/2000
(220) Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program < greek-
i>K86-3 (blue book memo) ODE 289 06/30/1986
(221) Guidance on the Use of Standards in Substantial Equivalence Determinations; Final ODE 1131 03/12/2000
(222) Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published
Literature, Use of Previously Submitted Materials, and Priority Review; Final ODE 380 05/20/1998
(223) Guideline on General Principles of Process Validation ODE 425 05/01/1987
(224) Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test ODE
427 12/01/1987
(225) HCFA Reimbursement Categorization Determinations for FDA-approved IDEs ODE 4106 09/15/1995
(226) Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for Industry ODE
1381 07/12/2001
(227) IDE Refuse to Accept Procedures D94-1 (blue book memo) ODE 410 05/20/1994
(228) Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of
Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Catergorization of Investigational
Devices, & Att. C -List D95-2 (blue book memo) ODE 106 09/15/1995
(229) Indications for Use Statement ODE 879 01/02/1996
(230) Industry Representatives on Scientific Panel ODE 329 03/27/1987
(231) Integrity of Data and Information Submitted to ODE I91-2 (blue book memo) ODE 447 05/29/1991
(232) Kit Certification for 510(k)s ODE 562 07/01/1997
(233) Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance ODE
198 04/01/1996
(234) Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert,
Ph.D.,M.D. ODE 883 05/26/1994
(235) Limulus Amebocute Lysate; Reduction of Samples for Testing ODE 178 10/23/1987
(236) Master Files Part III; Guidance on Scientific and Technical Information ODE 338 06/01/1987
(237) Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices),
Guidance for FDA Reviewers and Industry; Final ODE 2206 11/16/1998
(238) Meetings with the Regulated Industry I89-3 (blue book Memo) ODE 367 11/20/1989
(239) Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo G96-3) ODE 806 08/
09/1996
(240) Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and Solutions ODE 639 06/13/1995
(241) Methods for Conducting Recall Effectiveness Checks ODE 225 06/16/1978
(242) New section 513(f)(2)--Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH
Staff; Final ODE 199 02/19/1998
(243) Nondisclosure of Financially Sensitive Information I92-1 (blue book memo) ODE 587 03/05/1992
(244) ODE Executive Secretary Guidance Manual G87-3 ODE 1338 08/07/1987
(245) Panel Report and Recommendations on PMA Approvals P86-5 (blue book memo) ODE 306 04/18/1986
(246) Panel Review of Premarket Approval Applications P91-2 (blue book memo) ODE 444 05/03/1991
(247) Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff ODE 1208 06/03/2003
(248) PMA Compliance Program P91-3 (blue book memo) ODE 445 05/03/1991
(249) Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products ODE 269 06/01/
1984
[[Page 15446]]
(250) Policy Development and Review Procedures I90-1 (blue book memo) ODE 368 02/15/1990
(251) Preamendment Class III Devices ODE 584 03/11/1992
(252) Preamendments Class III Strategy ODE 611 04/19/1994
(253) Premarket Approval Application (PMA) Closure P94-2 (blue book memo) ODE 403 07/08/1994
(254) Premarket Approval Application Modular Review--Guidance for Industry and FDA Staff ODE 835 11/03/2003
(255) Premarket Notification--Consistency of Reviews K89-1 (blue Book memo) ODE 339 02/28/1989
(256) Premarket Notification [510(k)] Status Request Form ODE 858 03/07/1994
(257) Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH
Staff; Final ODE 159 02/19/1998
(258) Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in
Health Care Facilities ODE 1198 09/03/1996
(259) Real-Time Review Program for Premarket Approval Application (PMA) Supplements ODE 673 04/22/1997
(260) Review of IDEs for Feasibility Studies D89-1 (blue book memo) ODE 362 05/17/1989
(261) Review of Laser Submissions G88-1 (blue book memo) ODE 330 04/15/1988
(262) Shelf Life of Medical Devices ODE 415 04/01/1991
(263) SMDA Changes--Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert ODE
655 04/17/1992
(264) Substantial Equivalence (SE) Decision Making Documentation ATTACHED: 'SE' Decision Making Process
(Detailed) i.e. the decision making tree ODE 390 01/01/1990
(265) Suggested Content for Original IDE Application Cover Letter ODE 797 02/27/1996
(266) Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome
Provisions of FDAMA ODE 1195 11/02/2000
(267) Telephone Communications Between ODE Staff and Manufacturers I93-1 (blue book memo) ODE 360 01/29/
1993
(268) The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final
Guidance for FDA and Industry ODE 1332 10/04/2002
(269) Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed
Prior to May 28, 1976 ODE 352 01/01/1990
(270) Toxicology Risk Assessment Committee G89-1 (blue book memo) ODE 363 08/09/1989
(271) Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA ODE 361 08/30/2002
(272) Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and
Testing' (Replaces G87-1 8294) (blue book memo) ODE 164 05/01/1995
(273) Draft Guidance for Industry and FDA Staff--Functional Indications for Implantable Cardioverter
Defibrillators ODE OC 1304 10/06/2005
(274) Guidance for Industry--Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
ODE OC 1553 01/14/2005
(275) Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in
Health Care Facilities ODE/DAGID 1833 09/19/1995
(276) Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDA ODE/DAGID 1178
07/17/2002
(277) Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and
Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA ODE/DAGID 1203 04/22/2003
(278) Dental Cements--Premarket Notification; Final ODE/DAGID 2204 08/18/1998
(279) Dental Impression Materials--Premarket Notification; Final ODE/DAGID 2203 08/17/1998
(280) Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation
Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices ODE/DAGID 1216
06/01/2004
(281) Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities ODE/
DAGID 833 03/01/1993
(282) Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints ODE/DAGID
993 12/01/1995
(283) OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final ODE/DAGID
2205 08/17/1998
(284) Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; Draft ODE/DAGID 1156 02/08/
2000
(285) Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices; Final ODE/DAGID/
ARDB 1138 07/03/2000
(286) Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors;
Guidance for Industry and FDA ODE/DAGID/ARDB 1335 12/13/2002
(287) Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry
and FDA ODE/DAGID/ARDB 1126 10/05/2001
(288) Draft 510(K) Submission Requirements for Peak Flow Meters ODE/DAGID/ARDB 999 01/13/1994
(289) Draft Emergency Resuscitator Guidance ODE/DAGID/ARDB 985 04/14/1993
(290) Draft Reviewer Guidance for Ventilators ODE/DAGID/ARDB 500 07/01/1995
(291) Draft Reviewer Guidance on Face Masks and Shield for CPR ODE/DAGID/ARDB 996 03/16/1994
(292) Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI
standard) ODE/DAGID/ARDB 638 11/01/1993
(293) General Guidance Document: Non-Invasive Pulse Oximeter ODE/DAGID/ARDB 997 09/07/1992
(294) Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide
Analyzer and Nitrogen Dioxide Analyzer; Final ODE/DAGID/ARDB 1157 01/24/2000
(295) Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II ODE/
DAGID/ARDB 583 02/01/1989
(296) Guidance for Peak Flow Meters for Over-the-Counter Sale ODE/DAGID/ARDB 998 06/23/1992
(297) Heated Humidifier Review Guidance ODE/DAGID/ARDB 780 08/30/1991
(298) Review Guidance for Oxygen Generators and Oxygen Equipment ODE/DAGID/ARDB 986
(299) Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators ODE/DAGID/ARDB 784 10/01/
1993
(300) Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices--Guidance for
Industry and FDA Staff ODE/DAGID/DEDB 1393 12/02/2003
(301) Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea;
Guidance for Industry and FDA ODE/DAGID/DEDB 1378 11/12/2002
(302) Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental
Abutments--Guidance for Industry and FDA Staff ODE/DAGID/DEDB 1389 05/12/2004
(303) Dental Bone Grafting Material Devices--Class II Special Controls Guidance Document--Guidance for Industry
and FDA Staff ODE/DAGID/DEDB 1512 04/28/2005
(304) Dental Composite Resin Devices--Premarket Notification [510(k)] Submissions--Guidance for Industry and FDA
Staff ODE/DAGID/DEDB 642 10/26/2005
[[Page 15447]]
(305) Guidance Document on Dental Handpieces ODE/DAGID/DEDB 556 07/01/1995
(306) Guidance for Industry and FDA Staff--Class II Special Controls Document: Oral Rinse to Reduce the Adhesion
of Dental Plaque ODE/DAGID/DEDB 1559 09/20/2005
(307) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal Alloys
ODE/DAGID/DEDB 1416 08/23/2004
(308) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Noble Metal
Alloys ODE/DAGID/DEDB 1415 08/23/2004
(309) Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling;
Draft Guidance for Industry and FDA ODE/DAGID/DEDB 1192 02/20/2002
(310) Class II Special Controls Guidance document: Implantable Radiofrequency Transponder System for Patient
Identification and Health Information--Guidance for Industry and FDA Staff ODE/DAGID/GHDB 1541 12/10/2004
(311) Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and
FDA ODE/DAGID/GHDB 1326 03/12/2001
(312) Guidance for Industry and FDA Review Staff--Intravascular Administration Sets Premarket Notification
Submissions [510(k)] ODE/DAGID/GHDB 1189 04/15/2005
(313) Guidance on 510(k) Submissions for Implanted Infusion Ports ODE/DAGID/GHDB 392 10/01/1990
(314) Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular
Catheters ODE/DAGID/GHDB 824 03/16/1995
(315) Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic
Thermometers ODE/DAGID/GHDB 822 03/01/1993
(316) Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps ODE/
DAGID/GHDB 823 03/01/1993
(317) Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles
ODE/DAGID/GHDB 450 04/01/1993
(318) Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes ODE/DAGID/GHDB
821 04/01/1993
(319) Medical Devices with Sharps Injury Prevention Features--Guidance for Industry and FDA Staff ODE/DAGID/GHDB
934 08/09/2005
(320) Neonatal and Neonatal Transport Incubators--Premarket Notifications; Final ODE/DAGID/GHDB 2201 09/18/1998
(321) CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for use in Processing Reusable
Medical Devices ODE/DAGID/INCB 4 06/02/1998
(322) Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for
the Medical Device Industry and FDA Review Staff ODE/DAGID/INCB 1252 02/07/2002
(323) Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/
Disinfectors, and Disinfectors Intended for Use in Health Care Facilities ODE/DAGID/INCB 881 08/01/1993
(324) Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes ODE/DAGID/
INCB 888 08/01/1993
(325) Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical
Sterilants and High Level Disinfectants; Final ODE/DAGID/INCB 397 01/03/2000
(326) Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers
ODE/DAGID/INCB 895 10/01/1993
(327) Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's Glove--Guidance
for Industry and FDA Staff ODE/DAGID/INCB 1230 04/13/2004
(328) Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry
and FDA ODE/DAGID/INCB 891 03/02/2001
(329) Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care
Facilities; Draft Guidance for Industry and FDA ODE/DAGID/INCB 1388 03/07/2002
(330) Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural
Rubber Products; Final ODE/DAGID/INCB 944 01/13/1999
(331) Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health
Care Facilities; Draft Guidance for Industry and FDA Reviewers ODE/DAGID/INCB 05/21/2001
(332) Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification
Systems for Hemodialysis; Guidance for Industry and FDA ODE/DAGID/INCB 1419 08/30/2002
(333) Surgical Masks--Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA ODE/DAGID/INCB
94 03/05/2004
(334) Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) ODE/DAGID/INCB
1944 07/28/1997
(335) Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA Application ODE/DCD 370
01/01/1989
(336) Battery Guidance ODE/DCD 873 01/01/1994
(337) Policy for Expiration Dating (DCRND RB92-G) ODE/DCD 137 10/30/1992
(338) Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for Industry ODE/DCD/CEMB 1382
07/01/2002
(339) Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm ODE/DCD/CEMB 1363 10/28/2003
(340) Clinical Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial Fibrillation--Guidance
for Industry and FDA Staff ODE/DCD/CEMB 1229 01/09/2004
(341) Coronary and Peripheral Arterial Diagnostic Catheters--Guidance for Industry and FDA Staff ODE/DCD/CEMB
1228 07/15/2003
(342) Electrocardiograph (ECG) Electrode ODE/DCD/CEMB 25 02/11/1997
(343) Electrocardiograph (ECG) Lead Switching Adapter ODE/DCD/CEMB 26 02/11/1997
(344) Electrocardiograph (ECG) Surface Electrode Tester ODE/DCD/CEMB 27 02/11/1997
(345) Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter;
Final Guidance for Industry and FDA Reviewers ODE/DCD/CEMB 1199 11/08/2000
(346) Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final ODE/DCD/CEMB 2239 11/19/
1998
(347) Non-Invasive Blood Pressure (NIBP) Monitor Guidance ODE/DCD/CEMB 123 03/10/1997
(348) Recommended Clinical Study Design for Ventricular Tachycardia Ablation ODE/DCD/CEMB 2244 05/07/1999
(349) Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff ODE/DCD/CSPB
1358 01/31/2001
(350) Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for
Industry and FDA ODE/DCD/CSPB 1622 11/29/2000
(351) Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA
Staff ODE/DCD/CSPB 1361 11/13/2000
(352) Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA
ODE/DCD/CSPB 1632 11/29/2000
[[Page 15448]]
(353) Coronary and Cerebrovascular Guidewire Guidance ODE/DCD/ICDB 964 01/01/1995
(354) 1-Consolidated Annual Report for a Device Product Line (1-CARD); Pilot for Preparation of Annual Reports
for Pacemaker Premarket Approval Applications ODE/DCD/PDLB 1167 07/06/2000
(355) Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Final ODE/DCD/PDLB 2233 11/05/1998
(356) Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Final ODE/DCD/PDLB 2232 11/05/
1998
(357) Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for
Pacemaker Lead Adaptor 510(k) Submissions ODE/DCD/PDLB 372 11/01/2000
(358) Implantable Pacemaker Testing Guidance ODE/DCD/PDLB 383 01/12/1990
(359) Carotid Stent--Suggestions for Content of Submissions to the Food and Drug Administration in Support of
Investigational Devices Exemption (IDE) Applications ODE/DCD/PVDB 974 10/26/1996
(360) Guidance Document for Vascular Prostheses 510(k) Submissions ODE/DCD/PVDB 1357 11/01/2000
(361) Guidance for Cardiovascular Intravascular Filter 510(k) Submissions; Final ODE/DCD/PVDB 24 11/26/1999
(362) Implantable Intra-Aneurysm Pressure Measurement System--Class II Special Controls Guidance Document ODE/
DCD/PVDB 1589 02/15/2006
(363) Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems--
Guidance for Industry and FDA Staff ODE/DCD/PVDB ODE/DCD/ICDB 1545 01/13/2005
(364) Guidance Document for Powered Suction Pump 510(k)s ODE/DGRND/GSDB 2207 09/30/1998
(365) Guidance Document for Surgical Lamp 510(k)s; Final ODE/DGRND/GSDB 1244 07/13/1998
(366) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph
Needle Electrodes ODE/DGRND/GSDB 325 07/26/1995
(367) Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices ODE/DGRND/GSDB
667 08/30/1994
(368) Guidance on the Content and Organization of a Premarket Notification for a Medical Laser ODE/DGRND/GSDB
386 06/01/1995
(369) Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response
Stimulators ODE/DGRND/GSDB 593 02/01/1997
(370) Premarket Notificaton [510(k)] Submissions for Chemical Indicators--Guidance for Industry and FDA Staff
ODE/DGRND/INCB 1420 12/19/2003
(371) 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants ODE/DGRND/ORDB 47 02/20/1997
(372) Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented
Prosthesis ODE/DGRND/ORDB 1328 04/30/2002
(373) Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer
Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA ODE/DGRND/ORDB 1418 01/16/2003
(374) Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for
Industry and FDA ODE/DGRND/ORDB 668 07/17/2002
(375) Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained
Porous-Coated Uncemented Prosthesis ODE/DGRND/ORDB 1193 10/31/2000
(376) Clinical Data Presentations for Orthopedic Device Applications--Guidance for Industry and FDA Staff ODE/
DGRND/ORDB 1542 12/02/2004
(377) Draft Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Intervertebral
Body Fusion Device ODE/DGRND/ORDB 1540 02/09/2006
(378) Guidance Document for Testing Biodegradable Polymer Implant Devices ODE/DGRND/ORDB 914 04/20/1996
(379) Guidance Document For Testing Bone Anchor Devices ODE/DGRND/ORDB 915 04/20/1996
(380) Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components ODE/
DGRND/ORDB 916 05/01/1995
(381) Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone
Cement ODE/DGRND/ORDB 827 04/28/1994
(382) Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prothetic Knee
Ligament Devices ODE/DGRND/ORDB 233 02/18/1993
(383) Guidance Document for the Preparation of IDEs for Spinal Systems ODE/DGRND/ORDB 2250 01/13/2000
(384) Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems ODE/DGRND/
ORDB 355 01/10/1995
(385) ORDB 510(k) Sterility Review Guidance ODE/DGRND/ORDB 659 07/03/1997
(386) Reviewers Guidance Checklist for Intramedullary Rods ODE/DGRND/ORDB 956 02/21/1997
(387) Reviewers Guidance Checklist for Orthopedic External Fixation Devices ODE/DGRND/ORDB 829 02/21/1997
(388) Spinal System 510(k)s--Guidance for Industry and FDA Staff ODE/DGRND/ORDB 636 05/03/2004
(389) Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA Staff ODE/
DGRND/PRSB 54 12/18/2003
(390) Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA ODE/DGRND/
PRSB 1387 06/03/2003
(391) Cyanoacrylate Tissue Adhesive for the Topical Approximation of Skin--Premarket Approval Applications
(PMAs)--Guidance for Industry and FDA Staff ODE/DGRND/PRSB 1233 02/13/2004
(392) Guidance Document for Dura Substitute Devices; Final Guidance for Industry ODE/DGRND/PRSB 1152 11/09/2000
(393) Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Final ODE/DGRND/
PRSB 6 04/28/1998
(394) Guidance for Dermabrasion Devices; Final ODE/DGRND/PRSB 2248 03/02/1999
(395) Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for
Industry ODE/DGRND/PRSB 1356 06/18/2002
(396) Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA ODE/
DGRND/PRSB 1354 02/11/2003
(397) Guidance for Testing MR Interaction with Aneurysm Clips ODE/DGRND/PRSB 958 05/22/1996
(398) Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final ODE/DGRND/
PRSB 2247 03/02/1999
(399) Low Energy Ultrasound Wound Cleaner: Class II Special Controls Guidance Document--Guidance for Industry
and FDA Staff ODE/DGRND/PRSB 1302 11/07/2005
(400) Saline, Silicone Gel, and Alternative Breast Implants--Draft Guidance for Industry and FDA Staff ODE/DGRND/
PRSB 1239 01/13/2004
(401) Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for
Industry and FDA ODE/DGRND/REDB 855 06/02/2003
(402) Guidance Document for Powered Muscle Stimulator 510(k)s; Final ODE/DGRND/REDB 2246 06/09/1999
(403) Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and
Vibrators ODE/DGRND/REDB 818 07/26/1995
[[Page 15449]]
(404) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications
Systems (Powered and Non-Powered) and Powered Environmental Control Systems ODE/DGRND/REDB 762 07/26/1995
(405) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise
Equipment ODE/DGRND/REDB 326 07/26/1995
(406) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and
Cooling Devices ODE/DGRND/REDB 828 07/26/1995
(407) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion
Hydrobaths ODE/DGRND/REDB 729 07/26/1995
(408) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables
and Multifunctional Physical Therapy Tables ODE/DGRND/REDB 735 07/26/1995
(409) Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged
(Underwater) Exercise Equipment ODE/DGRND/REDB 307 07/26/1995
(410) Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and
Powered Wheelchairs, and Motorized Three-Wheeled Vehicles ODE/DGRND/REDB 346 07/26/1995
(411) Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies
for Pain-Alleviating Devices ODE/DGRND/REDB 640 05/12/1988
(412) Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures--
Guidance for Industry and FDA Staff ODE/DGRND/REDB ODE/DGRND/ORDB 1543 10/24/2004
(413) Guidance for Industry; Noise Claims in Hearing Aid Labeling; Final ODE/DOED 2210 10/21/1998
(414) Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for
Refractive Surgery Lasers [excimer] ODE/DOED/DSDB 2093 10/10/1996
(415) Discussion Points for Expansion of the 'Checklist of Information Usually Submitted in an Investigational
Device Exemption (IDE) Application for Refractive Surgery Lasers' Draft Document ODE/DOED/DSDB 7093 09/05/1997
(416) Guidance Document for Nonprescription Sunglasses; Final ODE/DOED/DSDB 2208 10/09/1998
(417) Information for Keratome Manufacturers Regarding LASIK; Final Guidance for Industry ODE/DOED/DSDB 1376 06/
21/2001
(418) Ophthalmoscope Guidance ODE/DOED/DSDB 1241 07/08/1998
(419) Retinoscope Guidance; Final ODE/DOED/DSDB 1240 07/08/1998
(420) Slit Lamp Guidance; Final ODE/DOED/DSDB 1242 07/08/1998
(421) Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) ODE/DOED/
DSDB 2197 01/31/1997
(422) Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) ODE/
DOED/DSDB 2196 01/31/1997
(423) Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry
and FDA ODE/DOED/ENTB 791 04/29/2002
(424) Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS);
Guidance for Industry and FDA ODE/DOED/ENTB 1414 11/07/2002
(425) Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as
Protective Barriers; Final ODE/DOED/ENTB 954 03/12/2000
(426) Implantable Middle Ear Hearing Device; Guidance for Industry and FDA ODE/DOED/ENTB 1406 08/01/2003
(427) Tinnitus Masker Devices--Class II Special Controls Guidance Document--Draft Guidance for Industry and FDA
Staff ODE/DOED/ENTB 1555 10/08/2005
(428) Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; Final ODE/DOED/ENTB 930 01/14/
1998
(429) Vocal Fold Medialization Devices--Premarket Notification [510(k)] Submissions--Guidance for Industry and
FDA Staff ODE/DOED/ENTB 1535 02/13/2004
(430) Aqueous Shunts--510(k) Submissions; Final ODE/DOED/ICIB 2236 11/16/1998
(431) Guidance on 510(k) Submissions for Keratoprostheses, Final ODE/DOED/ICIB 1351 03/03/1999
(432) Important Information About Rophae Intraocular Lenses ODE/DOED/ICIB 811 08/20/1992
(433) Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; Final ODE/DOED/
VEDB 1134 04/10/2000
(434) New FDA Recommendations & Results of Contact Lens Study (7 day letter) ODE/DOED/VEDB 265 05/30/1989
(435) Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses ODE/DOED/VEDB 896
06/28/1994
(436) Premarket Notification 510(k) Guidance for Contact Lens Care Products ODE/DOED/VEDB 674 05/01/1997
(437) Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for
Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final ODE/DOED/VEDB 1249 08/11/1998
(438) Bone Sonometer PMA Applications; Final Guidance for Industry and FDA ODE/DRARD 1377 06/21/2001
(439) Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices--Guidance for
Industry and FDA Staff ODE/DRARD 793 07/14/2003
(440) Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final ODE/DRARD 644 08/06/
1999
(441) Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and
Accessories (SPECT and PET) and Nuclear Tomography Systems; Final ODE/DRARD 2240 12/03/1998
(442) Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final
ODE/DRARD 340 11/14/1998
(443) Guidance for the Submission of Premarket Notifications for Medical Image Management Devices ODE/DRARD 416
07/27/2000
(444) Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources ODE/DRARD
1177 08/02/2000
(445) Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final ODE/DRARD
2238 11/20/1998
(446) Harmonic Imaging with/without Contrast--Premarket Notification; Final ODE/DRARD 2234 11/16/1998
(447) Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
ODE/DRARD 560 09/30/1997
(448) Letter: Notice to Manufacturers of Bone Mineral Densitometers ODE/DRARD 552 09/25/1997
(449) Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA ODE/DRARD 983
02/16/2001
(450) Reviewer Guidance for Automatic X-Ray Film Processor 510(k) ODE/DRARD 788 02/01/1990
(451) Simplified 510(k) procedures for certain radiology devices: 12/21/93 letter from L Yin, ODE/DRAERD, to
NEMA ODE/DRARD 708 12/21/1993
(452) Class II Special Controls Guidance Document: Tissue Culture Media for Human ex vivo Tissue and Cell
Culture Processing Applications; Final Guidance for Industry and FDA Reviewers ODE/DRARD/GRDB 1325 05/16/2001
(453) Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging
System; Final Guidance for Industry and FDA ODE/DRARD/GRDB 1385 11/28/2001
[[Page 15450]]
(454) Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis
Delivery Systems; Final ODE/DRARD/GRDB 2202 08/07/1998
(455) Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and
Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers ODE/DRARD/GRDB 1164 01/16/
2001
(456) Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers;
Final ODE/DRARD/GRDB 421 08/07/1998
(457) Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; Final ODE/DRARD/
GRDB 2243 02/05/1998
(458) Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for
Hemodialysis ODE/DRARD/GRDB 842 05/30/1997
(459) Class II Special Controls Guidance Document for Clitoral Engorgement Devices ODE/DRARD/OGDB 1144 07/03/
2000
(460) Class II Special Controls Guidance Document: Breast Lesion Documentation System--Guidance for Industry and
FDA Staff ODE/DRARD/OGDB 1202 07/28/2003
(461) Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA
Reviewers ODE/DRARD/OGDB 820 03/09/2001
(462) Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode ODE/DRARD/OGDB 244 03/08/1977
(463) Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices ODE/DRARD/OGDB 248 05/10/
1978
(464) Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)
ODE/DRARD/OGDB 232 05/01/1978
(465) Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices ODE/DRARD/OGDB 245 11/22/1977
(466) Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Assisted Reproduction
Laser Systems ODE/DRARD/OGDB 1539 12/28/2004
(467) Guidance for Industry and FDA Staff--Menstrual Tampons and Pads: Information for Premarket Notification
Submissions (510(k)s) ODE/DRARD/OGDB 166 07/27/2005
(468) Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for
Industry ODE/DRARD/OGDB 1356 06/18/2002
(469) Guidelines for Evaluation of Non-Drug IUDs ODE/DRARD/OGDB 641 09/28/1976
(470) Hysteroscopes and Gynecology Laparoscopes--Submission Guidance for a 510(k) ODE/DRARD/OGDB 907 03/07/1996
(471) Hysteroscopes and Laparoscopic Insufflators: Submission Guidance for a 510(k) ODE/DRARD/OGDB 1907 08/01/
1995
(472) Latex Condoms for Men--Information for 510(k) Premarket Notifications: Use of Consensus Standards for
Abbreviated Submissions ODE/DRARD/OGDB 1250 07/23/1998
(473) Letter to Manufacturers of Falloposcopes ODE/DRARD/OGDB 1344 09/05/1996
(474) Letter to Manufacturers of Prescription Home Monitors for Non-Stress Tests ODE/DRARD/OGDB 1342 09/06/1996
(475) Premarket Testing Guidelines for Female Barrier Contraceptive Devices also intended to prevent sexually
transmitted diseases ODE/DRARD/OGDB 384 04/04/1990
(476) Testing guidance for Male Condoms Made from New Material (Non-Latex) ODE/DRARD/OGDB 455 06/29/1995
(477) Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) ODE/DRARD/OGDB 547 03/14/1996
(478) Uniform Contraceptive Labeling; Final ODE/DRARD/OGDB 1251 07/23/1998
(479) Vascular and Neurovascular Embolization Devices--Class II Special Controls Guidance Document--Guidance for
Industry and FDA Staff ODE/DRARD/OGDB ODE/DGRND/PRSB ODE/DCD/PVDB 1234 12/29/2004
(480) Bone Sonometers--Class II Special Controls Guidance Document--Draft Guidance for Industry and FDA Staff
ODE/DRARD/RDB 1547 02/15/2006
(481) 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments ODE/DRARD/ULDB
892 09/19/1994
(482) Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology ODE/DRARD/
ULDB 98 11/01/1994
(483) Class II Special Controls Guidance Document: External Penile Rigidity Devices ODE/DRARD/ULDB 1231 12/28/
2004
(484) Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters
Indicated for the Fragmentation of Kidney and Ureteral Calculi ODE/DRARD/ULDB 1226 08/09/2000
(485) Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and
Urology ODE/DRARD/ULDB 482 02/10/1993
(486) Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters ODE/
DRARD/ULDB 97 09/12/1994
(487) Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final ODE/DRARD/ULDB
2235 11/30/1998
(488) Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final ODE/DRARD/ULDB 177
01/16/2000
(489) Guidance for the Content of Premarket Notifications for Ureteral Stents ODE/DRARD/ULDB 431 02/10/1993
(490) Guidance for the Content of Premarket Notifications for Urine Drainage Bags ODE/DRARD/ULDB 96 06/07/1994
(491) Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry Systems ODE/DRARD/ULDB 490
07/29/1994
(492) Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry OIVD 1205 02/26/2003
(493) Assessing the Safety/Effectiveness of Home-use In Vitro Diagnostic Devices (IVDs): Draft Points to
Consider Regarding Labeling and Premarket Submissions OIVD 272 10/01/1988
(494) Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff OIVD 857 12/03/2002
(495) Guidance for Administrative Procedures for CLIA Categorization OIVD 1143 08/14/2000
(496) Guidance for Industry--Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final OIVD 1247
02/22/1999
(497) Guidance for Industry and FDA Staff; Replacement Reagent and Instrument Family Policy OIVD 950 12/11/2003
(498) Guidance on Labeling for Laboratory Tests; Draft OIVD 1352 06/24/1999
(499) Guideline for the Manufacture of In Vitro Diagnostic Products OIVD 918 01/10/1994
(500) Letter to IVD Manufacturers on Streamlined PMA; Final OIVD 1395 12/22/1997
(501) Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance
OIVD 95 09/26/1994
(502) Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/
Cover Letter dated 3/14/1996 OIVD 553 02/01/1996
(503) Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft OIVD 2231 02/
03/1999
(504) Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications--Draft
Guidance for Industry and FDA Staff OIVD 1171 09/07/2005
(505) Draft Guidance for Industry and FDA Staff--Pharmacogenetic Tests and Genetic Tests for Heritable Markers
CBER CDER OIVD 1549 02/09/2006
(506) Format for Traditional and Abbreviated 510(k)s--Guidance for Industry and FDA Staff OIVD ODE 1567 08/12/
2005
[[Page 15451]]
(507) Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications OIVD ODE 2237 09/
28/2004
(508) Premarket Approval Application Filing Review--Guidance for Industry and FDA Staff OIVD ODE 297 05/01/2003
(509) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices--Guidance for
Industry and FDA Staff CBER OIVD ODE 337 05/11/2005
(510) Breath Nitric Oxide Test System--Class II Special Controls Guidance Document OIVD/DCTD 1211 07/07/2003
(511) Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final
Guidance for Industry and FDA Reviewers OIVD/DCTD 1072 11/30/2000
(512) Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and
FDA OIVD/DCTD 1380 09/16/2002
(513) Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing
OIVD/DCTD 1359 12/21/1999
(514) Drug Metabolizing Enzyme Genotyping System--Class II Special Controls Guidance Document--Guidance for
Industry and FDA Staff OIVD/DCTD 1551 03/10/2005
(515) Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home
Use OIVD/DCTD 605 07/14/1995
(516) Guidance for Industry--Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-
Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays OIVD/DCTD 1246 09/22/2005
(517) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Sirolimus Test Systems
OIVD/DCTD 1300 09/30/2004
(518) Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Final OIVD/DCTD 1102 07/
06/1998
(519) Guidance for Industry In Vitro Diagnostic Chloride Test System; Final OIVD/DCTD 1103 07/06/1998
(520) Guidance for Industry In Vitro Diagnostic Creatinine Test System; Final OIVD/DCTD 1104 07/02/1998
(521) Guidance for Industry In Vitro Diagnostic Glucose Test System; Final OIVD/DCTD 1105 07/06/1998
(522) Guidance for Industry In Vitro Diagnostic Potassium Test System; Final OIVD/DCTD 1107 07/06/1998
(523) Guidance for Industry In Vitro Diagnostic Sodium Test System; Final OIVD/DCTD 1109 07/06/1998
(524) Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; Final OIVD/DCTD 1110 07/06/1998
(525) Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s OIVD/DCTD 1172 07/22/2000
(526) Instrumentation for Clinical Multiplex Test Systems--Class II Special Controls Guidance Document--Guidance
for Industry and FDA Staff OIVD/DCTD 1546 03/10/2005
(527) Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass
Spectrometry--Class II Special Controls Guidance Document OIVD/DCTD 1301 12/24/2004
(528) Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate
Nursery OIVD/DCTD 122 02/20/1996
(529) Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests--Draft Guidance for
Industry and FDA Staff OIVD/DCTD 152 12/02/2003
(530) Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose
Oxidase, Dehydrogenase, or Hexokinase Methodology OIVD/DCTD 604 02/14/1996
(531) Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic
Devices (IVDs) OIVD/DCTD 1345 11/06/1996
(532) 510(k) Submissions for Coagulation Instruments--Guidance for Industry and FDA Staff OIVD/DIHD 1223 06/19/
2003
(533) CFTR Gene Mutation Detection Systems--Guidance for Industry and FDA Staff--Class II Special Controls
Guidance Document OIVD/DIHD 1564 10/26/2005
(534) Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody
(ASCA) Premarket Notifications OIVD/DIHD 1183 08/23/2000
(535) Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems OIVD/DIHD 1570 10/03/2005
(536) Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems--Guidance for
Industry and FDA Staff OIVD/DIHD 1236 03/16/2004
(537) Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell
Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA OIVD/DIHD 1184 12/04/2001
(538) Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and
Purification Systems for RT-PCR used in Molecular Diagnostic Testing) OIVD/DIHD 1563 08/25/2005
(539) Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s]; Final OIVD/DIHD
2241 04/28/1999
(540) Draft Guidance Document for 510(k) Submission of Fecal Occult Blood Tests OIVD/DIHD 772 07/29/1992
(541) Draft Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for
IVDs OIVD/DIHD 658 09/30/1991
(542) Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In
Vitro Devices OIVD/DIHD 785 09/01/1992
(543) Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies OIVD/
DIHD 475 09/26/1991
(544) Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDA
OIVD/DIHD 957 09/19/1996
(545) Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Automated Fluorescence
in situ Hybridization (FISH) Enumeration Systems OIVD/DIHD 1550 03/23/2005
(546) Guidance for Submission of Immunohistochemistry Applications to the FDA; Final OIVD/DIHD 364 06/03/1998
(547) Immunomagnetic Circulating Cancer Cell Selection and Enumeration System--Class II Special Controls
Guidance Document--Guidance for Industry and FDA Staff OIVD/DIHD 1531 05/11/2004
(548) In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Final OIVD/DIHD 2242 04/27/1999
(549) Points to Consider for Cervical Cytology Devices OIVD/DIHD 968 07/25/1994
(550) Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final
Guidance for Industry and FDA OIVD/DIHD 08/22/2001
(551) Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open
Neural Tube Defects Using Immunological Test Methodologies OIVD/DIHD 459 07/15/1994
(552) Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome
Analyzers OIVD/DIHD 417 07/15/1991
(553) Review Criteria for Assessment of Rheumatoid Factor(RF) In Vitro Diagnostic Devices Using Engzyme-Linked
Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate
Nephelometry OIVD/DIHD 165 02/21/1997
[[Page 15452]]
(554) Review Criteria for Blood Culture Systems OIVD/DIHD 82 08/12/1991
(555) Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents OIVD/DIHD
527 08/01/1992
(556) Review Criteria for In Vitro 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) OIVD/DIHD 51 02/01/1994
(557) Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology
for the Detection of Human Genetic Mutations (Germ Line and Somatic) OIVD/DIHD 980 02/15/1996
(558) Review Criteria for the Assessment of Anti-nuclear Antibodies (ANA) In-Vitro Diagnostic Devices Using
Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA)
OIVD/DIHD 848 09/01/1992
(559) Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for
Industry and FDa OIVD/DMD 631 02/05/2003
(560) Class II Special Controls Guidance Document: Endotoxin Assay OIVD/DMD 1222 10/31/2003
(561) Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance
Document: Herpes Simplex Virus Types 1 and 2 Serological Assays OIVD/DMD 1305 01/09/2006
(562) Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Hepatitis A Virus
Serological Assays OIVD/DMD 1536 02/09/2006
(563) Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Serological Reagents for
the Laboratory Diagnosis of West Nile Virus OIVD/DMD 1206 10/30/2003
(564) Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Serological Assays for
the Detection of Beta-Glucan OIVD/DMD 1825 09/23/2004
(565) Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens--Draft Guidance for
Industry and FDA Staff OIVD/DMD 1560 12/08/2005
(566) Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs OIVD/DMD 1631 10/30/1996
(567) Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in
Clinical Specimens OIVD/DMD 778 01/01/1992
(568) Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp.
[Tuberculosis (TB)] OIVD/DMD 862 07/06/1993
(569) Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori
OIVD/DMD 588 09/17/1992
(570) Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases OIVD/DMD 629 05/
31/1990
(571) Review Criteria for Devices Intended for the Detection of Hepatitis B 'e' Antigen and Antibody to HBe OIVD/
DMD 554 12/30/1991
(572) Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to
Parvovirus B19 OIVD/DMD 770 05/15/1992
(573) Addendum to the Instructions for Completing FDA form 3500A with Coding Manual (MEDWATCH)(MDR) OSB 06/09/
1999
(574) Perspectives on Clinical Studies for Medical Device Submissions (Statistical) OSB 78
(575) PMA Review Statistical Checklist OSB 84
(576) Statistical Guidance for Clinical Trials of Non Diagnostic Medical Devices OSB 476 01/01/1996
(577) Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for
Industry and FDA Reviewers OSB/DB 1428 03/12/2003
(578) Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support
Reconsideration of Postmarket Surveillance Requirements OSB/DPS 946 02/02/2000
(579) Guidance on Criteria and Approaches for Postmarket Surveillance OSB/DPS 9 11/02/1998
(580) Guidance on Procedures for Review of Postmarket Surveillance Submissions OSB/DPS 317 02/19/1998
(581) Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies OSB/DPS 316 02/19/
1998
(582) Procedures for Handling Post-Approval Studies Imposed by PMA Order--Draft Guidance for Industry and FDA
Staff OSB/DPS 09/15/2005
(583) SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance OSB/DPS 318 11/02/
1998
(584) Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment--Guidance for Industry and
FDA Staff OSB/DPS OCER/DDUPSA 1537 03/10/2006
(585) Common Problems: Baseline Reports and MedWatch Form 3500A (letter to manufacturers updated) OSB/DSS 379
(586) Instructions for Completing FDA Form 3500A with Coding Manual for Form 3500A (MEDWATCH) OSB/DSS 853 04/04/
2001
(587) Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR] OSB/DSS 1061 03/31/
1997
(588) MDR Guidance Document No. 1 - IOL - E1996004 OSB/DSS 216 08/07/1996
(589) Medical Device Reporting: An Overview OSB/DSS 509 04/01/1996
(590) MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting
OSB/DSS 854 06/01/1993
(591) Variance from Manufacturer Report Number Format OSB/DSS 08/12/1996
(592) Variance from Manufacturer Report Number Format [MDR letter] OSB/DSS 1059 07/16/1996
(593) Guidance for Industry: Medical Device Reporting--Alternative Summary Reporting (ASR) Program OSB/DSS/RSMB
315 10/19/2000
(594) Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original
Equipment Manufacturer for Single Use OSB/DSS/RSMB 1334 04/24/2001
(595) Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA OSB/DSS/RSMB 188 09/26/
2001
(596) Needlesticks--Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers OSB/DSS/
RSMB 250 11/12/2002
(597) CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards
for Recognition; Final Guidance for Industry OSEL 616 06/20/2001
(598) Draft Document--A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems OSEL 952
02/07/1997
(599) Frequently Asked Questions on the Recognition of Consensus Standards; Guidance for Industry and for FDA
Staff OSEL 109 07/22/2002
(600) Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA OSEL 321 06/20/2001
(601) Guidance for Industry Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year
2000 Date Problem OSEL/DECS 2000 05/15/1998
(602) Immunotoxicity Testing Guidance OSEL/DLS 635 05/06/1999
(603) 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Draft Guidance for Industry
OUT 09/24/2001
(604) 21 CFR Part 11; Electronic Records; Electronic Signatures, Validation; Draft Guidance for Industry OUT 09/
24/2001
(605) Combination Products--Timeliness of Premarket Reviews--Dispute Resolution Guidance--Draft Guidance for
Industry OUT 05/04/2004
(606) Computerized Systems Used in Clinical Trials OUT 04/01/1999
[[Page 15453]]
(607) Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic
Records OUT 11/12/2002
(608) Guidance for Industry and FDA Staff: Application User Fees for Combination Products OUT 04/21/2005
(609) Information Sheet Guidance for IRB's--Frequently Asked Questions about IRB Review of Medical Devices OUT
01/01/2006
(610) Information Sheet Guidance for IRB's--Significant Risk and Nonsignificant Risk Medical Device Studies OUT
01/01/2006
(611) Small Business Guide to FDA (FDA 96-1092) OUT 16 01/01/1996
----------------------------------------------------------------------------------------------------------------
V. Center for Food Safety and Applied Nutrition (CFSAN)
For information on a specific guidance document or to obtain a hard
copy, contact: Industry Activities Staff, Center for Food Safety and
Applied Nutrition/FDA, 5100 Paint Branch Pkwy., College Park, MD 20740,
301-436-2600, http://www.cfsan.fda.gov/~dms/guidance.html.
No CFSAN guidance documents were withdrawn from January 5, 2005, to
January 5, 2006.
The following is a copy of a list of current CFSAN guidance
documents obtained from the FDA Web site as of March 14, 2006.
CFSAN Guidance Documents (obtained from the FDA Web site on March 14, 2006)
Recently Issued Guidance
----------------------------------------------------------------------------------------------------------------
March 1, 2006: Draft Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and
Vegetables (Added to Produce)
March 1, 2006: Frequently Asked Questions about FDA's Regulation of Infant Formula (Updated in Infant Formula)
February 17, 2006: Whole Grain Label Statements (Added to Food Labeling)
January 30, 2006: Redbook 2000--Chapter IV.C.6: Carcinogenicity Studies with Rodents (Updated in Food and Color
Additives)
December 30, 2005: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective
Date of January 1, 2006 (Added to Food Labeling)
December 22, 2005: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level
and Enforcement Policy (Added to Chemical and Pesticide Contaminants)
December 14, 2005: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and
Consumer Protection Act of 2004 (Edition 2) (Added to Food Labeling)
----------------------------------------------------------------------------------------------------------------
General Publications
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual (August 2000; Updated April 2001) Consolidates the Administrative Guidelines
Manual. Lists levels of contamination at which regulatory actions will be invoked. Print version available from
NTIS. Their order numbers are: Foods and Cosmetics Order No. PB96-920500 Drugs and Biologics Order No. PB96-
920500 Veterinary Medicine Order No. PB96-920800 Medical and Radiological Devices Order No. PB96-920900 Source:
National Technical Information Service
Compliance Programs Guidance Manual (March 1995) Manual. Contains inspectional and analytical directives
implemented by FDA Field Units. Provides direction for general enforcement of laws and regulations. Order No.
PB95-915499 (manual only) Source: National Technical Information Service
FDA Recall Policy (2002) Explains the three classes of recalls and discusses FDA's role in the recall process.
Source: Industry Activities Staff
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations
Guidance for Small Businesses: Submission of Comments for CFSAN Rulemaking
Investigations Operations Manual (May 1996) Manual. Provides standard operation procedures for FDA
Investigators. The inspectional methods cover sanitation, micro problems, labeling, standards, and GMP's. Order
No. PB-95-913399 Source: National Technical Information Service
Regulatory Procedures Manual (August 1997) Contains directives for recalls, legal actions, and cooperative
agreements with states, such as those under the Public Health Service. Order No. PB95-265534 Source: National
Technical Information Service
----------------------------------------------------------------------------------------------------------------
Chemical and Pesticide Contaminants Publications
----------------------------------------------------------------------------------------------------------------
Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement
Policy (December 22, 2005)
Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been
Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
(May 2005)
Channels of Trade Policy for Commodities with Vinclozolin Residues (June 12, 2002)
FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments for Cry9C Protein
Residues (January 19, 2001)
Channels of Trade Policy for Commodities with Methyl Parathion Residues (December 2000)
Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (2000) Booklet. Lists
allowable action levels for contaminants in food and feed. Source: Industry Activities Staff
Pesticides Analytical Manual (1999) Contains the procedures and methods used in FDA labs for regulatory
examination of food and feed samples to determine compliance with the FD&C Act. Volume 1--Order No.PB94-911899
Source: National Technical Information Service
Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers
(June 13, 1995)
FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and
Grain By-Products for Animal Feed (September 16, 1993) Office of Plant & Dairy Foods & Beverages Food and Drug
Administration (HFS-306) 5100 Paint Branch Parkway College Park, MD 20740 (301) 436-2367 See also: Compliance
Policy Guides--Guidance for FDA Staff on Guidance Levels for Radionuclides in Domestic and Imported Foods July
2004
----------------------------------------------------------------------------------------------------------------
Cosmetic Publications
----------------------------------------------------------------------------------------------------------------
FDA's Cosmetic Labeling Manual (October 1991) Booklet. A summary of regulatory requirements for labeling of
cosmetics marketed in the United States. Available from: Food and Drug Administration Office of Cosmetics and
Colors (HFS-100) 5100 Paint Branch Parkway College Park, MD 20740-3235
Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (December 17, 2003)
[[Page 15454]]
Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients (January 10,
2005)
----------------------------------------------------------------------------------------------------------------
Dietary Supplements Publications
----------------------------------------------------------------------------------------------------------------
A Dietary Supplement Labeling Guide (April 2005)
Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and
Cosmetic Act (November 2004)
Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary
Supplements (July 10, 2003)
Interim Evidence-based Ranking System for Scientific Data (July 10, 2003)
Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity
Compliance Guide (January 1999) Source: Industry Activities Staff
Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements
(December 1999) Source: Office of Nutritional Products, Labeling & Dietary Supplements
Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific
Body (July 1998) Source: Office of Food Labeling
Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17,
2003)
----------------------------------------------------------------------------------------------------------------
Food and Color Additives Publications
----------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic Format--General Considerations (October 2003)
Providing Food and Color Additive Petitions in Electronic Format (July 2001)
Electronic Submission Forms (July 2001)
FDA's Policy for Foods Developed by Biotechnology (1995)
Partial List of Enzyme Preparations That are Used in Foods (2001)
Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food (2001)
Use of Antibiotic Resistance Marker Genes in Transgenic Plants (September 1998)
Enzyme Preparations: Chemistry Recommendations For Food Additive and GRAS Affirmation Petitions (January 1993)
Describes requirements for chemistry data needed to support food additive and GRAS petitions for the
preparation of enzymes used in processing food.Source: Office of Premarket Approval
Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances used in Food Contact Articles
(April 2005) Lists the information that should be submitted to FDA when requesting that the agency review a
specific use of a food contact article to determine whether its components will require regulation as a food
additive. Source: Office of Premarket Approval
Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations (December 1992)
This document provides assistance to manufacturers of food packaging in evaluating processes for producing
packaging from post-consumer recycled plastic. Source: Office of Premarket Approval
Frequently Asked Questions about Generally Recognized as Safe (GRAS) (December 2004) Source: Office of Food
Additive Safety
How to Submit a GRAS Notice (April 17, 1997)
Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food
Ingredient Petitions (May 1993) Describes the types of chemistry data necessary for supporting petitions for
regulations of direct food additives such as synthetic sweeteners, and preservatives; or the affirmation of the
use of food ingredients as generally recognized as safe (GRAS) such as sucrose, and many enzymes used in food
processing. Source: Office of Premarket Approval
Statement of Policy: Foods Derived from New Plant Varieties: Notice (May 1992) FEDERAL REGISTER notice dated May
29, 1992; 57 FR 22984. Source: Office of Premarket Approval
Guidelines for the Preparation of Petition Submissions (1996) Source: Office of Premarket Approval
Pre-petition Consultations for Food Additives and Color Additives (April 2005)
Guidelines for Approval of Color Additives in Contact Lenses Intended as Colors (1996) Source: Office of
Premarket Approval
FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs or
Cosmetics Use (January 1997) Source: Office of Premarket Approval
Estimating Exposure to Direct Food Additive and Chemical Contaminants in the Diet (September 1995) Source:
Office of Premarket Approval
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food
(also known as Redbook I) (1982) Source: National Technical Information Service (NTIS)
Toxicological Principles for the Safety of Food Ingredients (Redbook 2000) (July 7, 2000; Updated October 2001,
November 2003, January 2006) The Agency is in the process of updating the Redbook and is now making Redbook
2000 chapters available electronically. The Redbook 2000 chapters now substitute for, or supplement, guidance
available in the 1982 Redbook I (see above) and in the 1993 Draft Redbook II, which can be obtained from the
Office of Food Additive Safety. As additional chapters of Redbook 2000 are completed they will become available
electronically.
Toxicological Testing of Food Additives (1983) Source: Office of Premarket Approval
Templates for Reporting Toxicology Data (March 2004)
Draft Guidance: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the
Center for Food Safety and Applied Nutrition (September 17, 2003)
Environmental Assessment Technical Handbook (March, 1987) Order No. PB87175345-AS, A-01 Source: National
Technical Information Service (NTIS)
Guidance on Consultation Procedures Foods Derived From New Plant Varieties (October 1997) Source: Office of
Premarket Approval
Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use (November 2004)
Bovine Spongiform Encephalopathy (BSE) in Products for Human Use (1997) Executive Secretariat (HF-40) Food and
Drug Administration 5600 Fishers Lane Rockville, MD 20857
Food Additive Petition Expedited Review--Guidance for Industry and Center for Food Safety and Applied Nutrition
Staff (January 1999) Source: Office of Premarket Approval
Antimicrobial Food Additives--Guidance (July 1999) Source: Office of Premarket Approval
Preparation of Premarket Notifications for Food Contact Substances (Food Contact Notifications (FCN)):
Administrative Recommendations (May 2002)
Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry
Recommendations (April 2002) Source: Office of Food Additive Safety
[[Page 15455]]
Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations (April 2002)
Source: Office of Food Additive Safety
----------------------------------------------------------------------------------------------------------------
Food Labeling Publications
----------------------------------------------------------------------------------------------------------------
A Food Labeling Guide (May 1997) Booklet. This booklet is a summary of the required statements that must appear
on food labels. Source: Industry Activities Staff
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity
Compliance Guide (August 20, 2003)
Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1,
2006 (December 30, 2005)
Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary
Supplements (July 10, 2003)
Interim Evidence-based Ranking System for Scientific Data (July 10, 2003)
Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements (December 18, 2002)
Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering
(January 2001)
Small Business Food Labeling Exemption (June 1996) Information sheet and sample small business exemption
application form. Source: Industry Activities Staff
Food Labeling: Questions and Answers Volume I, (August 1994) Booklet. Provided to facilitate the advice to
retail businesses process of developing or revising labels for foods other than dietary supplements. Source:
Industry Activities Staff
Food Labeling: Questions and Answers Volume II, (February 1996) Booklet. Contains FDA's advice to retail
businesses and restaurants making health and nutrient claims on their food products. Source: Government
Printing Office
Fair Packaging and Labeling Act Manual (June, 1978) Book. Presents FDA's interpretations of the requirements of
the Fair Packaging and Labeling Act as it applies to foods, drugs, cosmetics, and medical devices. Order No. PB-
83-222117 Source: National Technical Information Service
Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, Sec.
10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated by
Irradiation. (available in PDF)
Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements
(December 1999) Source: Office of Nutritional Products, Labeling & Dietary Supplements
Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17,
2003)
Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific
Body (July 1998) Source: Office of Food Labeling
FDA Nutrition Labeling Manual--A Guide for Developing and Using Data Bases (March 1998) Source: Office of Food
Labeling
Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) Source: Office of Food
Labeling
Food Labeling--Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail
Distribution Small Entity Compliance Guide (July 2001)
Exemptions from the Warning Label Requirement for Juice--Recommendations for Effectively Achieving a 5-Log
Pathogen Reduction (October 7, 2002)
Food Labeling--Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance
Guide (July 2001)
Whole Grain Label Statements (February 2006)
Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act
of 2004 (Edition 2) (December 14, 2005)
----------------------------------------------------------------------------------------------------------------
Food Processing Publications
----------------------------------------------------------------------------------------------------------------
Bacteriological Analytical Manual 7th Edition (1992) Manual. Provides quantitative and qualitative
bacteriological testing procedures for detecting microbiological contamination. Contains screening procedures
for Salmonella, Shigella, Clostridium botulinum, etc. Source: AOAC International
Bacteriological Analytical Manual Online (2001)
----------------------------------------------------------------------------------------------------------------
Food and Cosmetic Security Publications
----------------------------------------------------------------------------------------------------------------
Entry Types and Entry Identifiers--Prior Notice of Imported Food (April 7, 2005)
Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (November 16, 2005)
Questions and Answers Regarding Establishment and Maintenance of Records (Edition 2) (November 10, 2005)
What You Need to Know About Establishment and Maintenance of Records (December 2004)
What You Need to Know About Administrative Detention of Foods (November 2004)
Prior Notice of Imported Food Contingency Plan for System Outages (August 12, 2004)
Questions and Answers Regarding Registration of Food Facilities (Edition 4) (August 6, 2004)
Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004)
Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (December 17, 2003)
Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (December 17,
2003)
What You Need to Know About Registration of Food Facilities (November 25, 2003)
What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003)
Necessity of the Use of Food Product Categories in Registration of Food Facilities (July 17, 2003)
Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security
Preventive Measures Guidance (July 11, 2003)
Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (March 21, 2003)
Importers and Filers: Food Security Preventive Measures Guidance (March 21, 2003)
See also: Compliance Policy Guides--Guidance for FDA Staff on enforcement of Registration of Food Facilities
December 2003, Last Revised November 2004 and Prior Notice of Imported Foods December 2003, Last Revised
November 2005
----------------------------------------------------------------------------------------------------------------
Imports and Exports Publications
----------------------------------------------------------------------------------------------------------------
[[Page 15456]]
Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators (August 26,
2004) HTS Codes Revision History
Prior Notice of Imported Food Contingency Plan for System Outages (August 12, 2004)
Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004)
What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003)
Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/
Processors with Interest in Exporting to Chile (June 22, 2005)
Importers and Filers: Food Security Preventive Measures Guidance (March 21, 2003)
Guidance for Industry: FDA Export Certificates (2002) (also available in PDF)
Draft Guidance: Regulatory Procedures Manual Chapter 9, Subchapter: Guidance Concerning Recommending Customs'
Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned (November 5, 2002)
Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers
(June 13, 1995)
FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods (1985) Booklet. Question-and-Answer guide for
importers, low-acid and acidified import requirements. Source: Industry Activities Staff
See also: Compliance Policy Guides--Guidance for FDA Staff on Guidance Levels for Radionuclides in Domestic and
Imported Foods July 2004
----------------------------------------------------------------------------------------------------------------
Infant Formula Publications
----------------------------------------------------------------------------------------------------------------
Frequently Asked Questions about FDA's Regulation of Infant Formula (March 1, 2006)
Guidelines Concerning Notification and Testing of Infant Formula (1985)Source: Office of Nutritional Products,
Labeling & Dietary Supplements
Guidelines for Evaluation of the Safety and Suitability of New Infant Formulas for Feeding Preterm Infants
(1988) Source: Office of Nutritional Products, Labeling & Dietary Supplements
Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Term Infants (1988) Source:
Office of Nutritional Products, Labeling & Dietary Supplements
Guidelines for Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants with Allergic
Diseases (1990) Source: Office of Nutritional Products, Labeling & Dietary Supplements
Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children and
Pregnant Women with Metabolic Disorders (1987) Source: Office of Nutritional Products, Labeling & Dietary
Supplements
----------------------------------------------------------------------------------------------------------------
Juice Publications
----------------------------------------------------------------------------------------------------------------
Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and
Cider (September 22, 2005)
Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes
(November 2004)
Juice HACCP Hazards and Control Guidance--First Edition (March 3, 2004)
The Juice HACCP Regulation: Questions and Answers (September 4, 2003)
Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (June 2003)
Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices (April 24, 2002)
Juice HACCP Small Entity Compliance Guide (April 4, 2003)
Exemptions from the Warning Label Requirement for Juice--Recommendations for Effectively Achieving a 5-Log
Pathogen Reduction (October 7, 2002)
Apple Juice, Apple Juice Concentrates, and Apple Juice Products--Adulteration with Patulin (October 2001)
The Juice HACCP Regulation: Questions & Answers (August 31, 2001)
Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide (September 18, 1998)
----------------------------------------------------------------------------------------------------------------
Low-Acid and Acidified Foods Publications
----------------------------------------------------------------------------------------------------------------
FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods (1985) Booklet. Question-and-Answer guide for
importers, low-acid and acidified import requirements. Source: Industry Activities Staff
----------------------------------------------------------------------------------------------------------------
Milk Sanitation Publications
----------------------------------------------------------------------------------------------------------------
Grade ``A'' Pasteurized Milk Ordinance 2003 Revision (March 2, 2004)
Grade ``A'' Pasteurized Milk Ordinance 2001 Revision (May 15, 2002)
Importation of PMO Defined Dairy Products (M-I-00-4) (April 11, 2000)
Evaluation of Milk Laboratories (1995 Edition) Provides the procedures for the evaluation of milk laboratories.
Source: Milk Safety Branch
Methods of Making Sanitation Ratings of Milk Supplies (1999) Rating method for evaluating sanitary quality of
milk. Source: Milk Safety Branch
Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for
Certification of Interstate Milk Shippers (1999) Provides procedures for a national reciprocity milk program.
Includes by-laws and constitution of the National Conference on Interstate Milk Shipments and the Memorandum of
Understanding between the National Conference and FDA. Source: Milk Safety Branch
Frozen Dessert Processing Guidelines (1989) Sanitation Standards. Source: Milk Safety Branch
Dry Milk Ordinance (1995) Source: Milk Safety Branch
Pasteurized Milk Ordinance (1999) Source: Milk Safety Branch
----------------------------------------------------------------------------------------------------------------
Natural Toxins Publications
----------------------------------------------------------------------------------------------------------------
Apple Juice, Apple Juice Concentrates, and Apple Juice Products--Adulteration with Patulin (October 2001)
Fumonisin Levels in Human Foods and Animal Feeds (November 9, 2001)
----------------------------------------------------------------------------------------------------------------
Nutrition and Food Science Publications
----------------------------------------------------------------------------------------------------------------
FDA Nutrition Labeling Manual--A Guide for Developing and Using Data Bases (March 1998) Generic instructions for
developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not
available for the food (single or mixed products) to be labeled. Source: Office of Food Labeling
[[Page 15457]]
Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993) Source: Office of Food
Labeling
List of Products for Each Product Category (October 8, 1992) Source: Office of Food Labeling
Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996) Source: Office of
Food Labeling
Guidance on Labeling of Foods that Need Refrigeration by Consumers (February 24, 1997) 62 FR 8248 Source: Office
of Food Labeling
Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant
Bovine Somatropin (February 10, 1994) 59 FR 6279 Source: Office of Food Labeling
----------------------------------------------------------------------------------------------------------------
Produce Publications
----------------------------------------------------------------------------------------------------------------
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (October 26, 1998) (Also
available in French, Spanish, Portuguese and Arabic) Source: Food Safety Initiative Staff
Draft Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (March 1,
2006)
Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999) Source: Office of Plant and Dairy Foods
and Beverages
Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production (October 1999) Source: Office
of Plant and Dairy Foods and Beverages
----------------------------------------------------------------------------------------------------------------
Retail Food Protection Publications
----------------------------------------------------------------------------------------------------------------
A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and
Transporters of Food Products on Decontamination of Transport Vehicles (October 7, 2005)
Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance (December 17,
2003)
Food Labeling--Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail
Distribution Small Entity Compliance Guide (July 2001)
----------------------------------------------------------------------------------------------------------------
Sanitation Publications
----------------------------------------------------------------------------------------------------------------
Foods--Adulteration Involving Hard or Sharp Foreign Objects (February 1999) Compliance Policy Guide Chapter 5
Subchapter 555 Section 555.425
Defect Action Levels (DALS) (1995; Revised March 1997 and May 1998) Booklet. This list is compiled from FDA's
Compliance Policy Guides on established ``current levels for natural or unavoidable defects in food for human
use that present no health hazards.'' Source: Industry Activities Staff
Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (2000) Source: Industry Activities
Staff
----------------------------------------------------------------------------------------------------------------
Seafood Publications
----------------------------------------------------------------------------------------------------------------
Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and
Fishery Products (July 2001) Source: Office of Seafood
Seafood HACCP Transition Policy (December 1999) Source: Office of Seafood Seafood List (1993) Booklet. FDA's
guide to acceptable market names for seafood sold in the interstate commerce.
Fish and Fisheries Products Hazards and Control Guide 3rd Edition (2001) Source: Office of Seafood
HACCP Regulation for Fish and Fishery Products: Questions and Answers (1998) Source: Office of Seafood
Certification of Fish and Fishery Products for Export to the European Union and European Free Trade Association
(November 2004)
Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric
Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery
Products for Export to the European Union and the European Free Trade Association (November 2004)
Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the
Use of the Term ``Catfish'' (December 2002)
Letter to Various Seafood Trade Associations Regarding the Labeling of Catfish (February 28, 2003)
----------------------------------------------------------------------------------------------------------------
Small Entity Compliance Guides Publications
----------------------------------------------------------------------------------------------------------------
What You Need to Know About Establishment and Maintenance of Records (December 2004)
What You Need to Know About Registration of Food Facilities (November 25, 2003)
What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003)
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity
Compliance Guide (August 20, 2003)
Juice HACCP Small Entity Compliance Guide (April 4, 2003)
Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
Food Labeling--Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail
Distribution Small Entity Compliance Guide (July 2001)
Food Labeling--Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance
Guide (July 2001)
Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity
Compliance Guide (January 1999) Source: Industry Activities Staff
Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17,
2003)
----------------------------------------------------------------------------------------------------------------
VI. Center for Veterinary Medicine (CVM)
For information on a specific guidance document or to obtain a hard
copy, contact: Communications Staff, Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855,
301-827-3800, http://www.fda.gov/cvm/guidance/published.htm.
The following is a list of CVM guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
[[Page 15458]]
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
------------------------------------------------------------------------
78 Consideration of the Human 12/1999 1/2006
Health Impact of the Microbial Effects
of Antimicrobial New Animal Drugs
Intended for Use in Food-Producing
Animals
------------------------------------------------------------------------
The following is a copy of a list of current CVM guidance documents
obtained from the FDA Web site as of March 14, 2006.
CVM Guidance Documents (obtained from the FDA Web site on March 14, 2006)
1. Anticoccidial Guidelines replaced by Guideline 40
2. Anthelmintics Withdrawn 12/22/2004
3. General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals 06/21/05
4. Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle Withdrawn 12/22/
2004
5. Stability Guidelines 12/90
6. Guidelines for Submitting NADA's for Generic Drugs Reviewed by NAS/NRC 10/20/71; rev. 03/19/76
8. Guidelines for Toxicological Investigations replaced by Guideline number 3
9. Preclearance Guidelines for Production Drugs Withdrawn pending revisions
10. Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines 10/75
13. Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds revision of
Medicated Block 01/85
14. Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug
in Food Producing Animals Withdrawn 12/22/2004
15. Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug
in Non-Food Producing Animals (2277) Withdrawn 12/22/2004
16. FOI Summary Guideline 05/85
17. Working Guidelines for Assigning Residue Tolerances replaced by Guideline 3
18. Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria Withdrawn 12/22/2004
19. Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria Withdrawn 12/22/2004
20. Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria Withdrawn 12/22/2004
21. Nutritional Ingredients in Animal Drugs and Feeds Nutritional Ingredients in Animal Drugs and Feeds (see
Policy and Procedures Guide 1240.3420) rev. 03/93
22. Guideline Labeling of Arecoline Base Drugs Intended for Animal Use
23. Medicated Free Choice Feeds--Manufacturing Control 07/85
24. Guidelines for Drug Combinations for Use in Animals 10/83
25. Guidelines for the Efficacy Evaluation of Equine Anthelmintics Replaced by Guidance 109
26. Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding
Animal Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal
Drugs (superceded by Guidance 61) 04/86; see also Guideline 61, below.
27. New Animal Drug Determinations (see Policy and Procedures Guide 1240.3500) 07/89
28. Animal Drug Applications Expedited Review Guideline (see Policy and Procedures Guide 1240.3135) 06/90
29. Guidelines for the Effectiveness Evaluation of Swine Anthelmintics 09/80
30. Guidelines for Anti-infective Bovine Mastitis Product Development replaced by guideline 49
31. Guidelines for the Evaluation of Bovine Anthelmintics 07/81
32. Guideline for Threshold Assessment replaced by Guideline number 3
33. Target Animal Safety Guidelines for New Animal Drugs 06/89
34. Biomass Guideline--Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food
Safety Evaluation replaced by Guideline number 3
35. Bioequivalence Guideline revised 10/09/02
36. Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics 07/85
37. Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for Pigmentation 03/
84
38. Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs 03/84
39. Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors
for Investigational New Animal Drug Studies replaced by Guidance 85
40. Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug
Combinations in Poultry 04/92
41. Draft Guideline: Formatting, Assembling, and Submitting New Animal Drug Applications 06/92
42. Series of four guidelines entitled ``Animal Drug Manufacturing Guidelines'' 1994
43. Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances 10/95
45. Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle 08/93
48. Guidance for Industry: Submission Documentation for Sterilization Process Validation in Applications for
Human and Veterinary Drug Products 11/94
49. Guidance Document For Target Animal Safety And Drug Effectiveness Studies For Anti-Microbial Bovine Mastitis
Products (Lactating and Non-Lactating Cow Products) 04/96
50. Draft Guideline for Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing
Studies for Teat Antiseptic Products 02/93
51. Points to Consider Guideline--Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of
Therapeutic Antimicrobials ``Please see Guidance 66 for updated information.''
52. Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal
Flora, February 18, 2004 Replaced by Guidance 159
53. Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals 05/94
54. Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds--See Final
Guidance 80 06/94
55. Supportive Data for Cat Food Labels Bearing ``Reduces Urinary pH Claims: Guideline in Protocol Development
06/94
56. Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials 07/10/01
57. Master Files: Guidance for Industry for the Preparation and Submission of Veterinary Master Files 1995
58. Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors Withdrawn
12/22/2004; superceded by guidance 85
[[Page 15459]]
59. Guidance for Industry: How to Submit a Notice of Claimed Investigational Exemption in Electronic Format by E-
Mail 01/17/06
60. Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide Replaced
by Guidance 67, 68, 69, and 70
61. Guidance For Industry: FDA Approval of New Animal Drugs for Minor Uses and for Minor Species 04/99
62. Guidance for Industry: Consumer-Directed Broadcast Advertisements: Final Guidance 08/99
63. Guidance for Industry: Validation of Analytical Procedures: Definition and Terminology 07/99
64. Guidance for Industry: Validation of Analytical Procedures: Methodology: Final Guidance 07/99
65. Guidance for Industry: Industry-Supported Scientific and Educational Activities 11/97
66. Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs 01/02
67. Guidance for Industry: Small Entities Compliance Guide for Renderers 02/98
68. Guidance for Industry: Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and
Distributors 02/98
68. Gu[iacute]a de la FDA para la Industria N[uacute]mero 68: Para Mezcladores de Prote[iacute]nas, Fabricantes
de Alimentos para Animales y Distribuidores 02/09
69. Gu[iacute]a de la FDA para la Industria N[uacute]mero 69: Para Alimentadores de Animales Rumiantes con
Operaciones de Mezclado de Alimentos en la Granja 02/98
69. Guidance for Industry: Small Entities Compliance Guide for for Feeders of Ruminant Animals with On-Farm Feed
Mixing Operations 02/98
70. Guidance for Industry: Small Entities Compliance Guide for Feeders of Ruminant Animals without On-Farm Feed
Mixing Operations 02/98
70. Gu[iacute]a de la FDA para la Industria N[uacute]mero70: Para Alimentadores de Animales Rumiantes sin
Operaciones de Mezclado de Alimentos en la Granja 02/98
71. Guidance for Industry: Use of Human Chorionic Gonadotropin (HCG) as a Spawning Aid for Fish Rescinded
72. Guidance For Industry: GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with
FDA 05/98
73. Guidance For industry: Stability Testing Of New Veterinary Drug Substances And Medicinal Products VICH GL3:
FINAL GUIDANCE 09/99
74. Guidance for Industry: Stability Testing of New Veterinary Dosage Forms VICH GL4: FINAL GUIDANCE 09/99
75. Guidance For Industry: Stability Testing: Photostability Testing of New Veterinary Drug Substances and
Medicinal Products: Final GUIDANCE 09/99
76. Guidance For Industry: Questions and Answers BSE Feed Regulations 07/98
77. Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE
Withdrawn 06/12/03
78. Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended
for Use in Food-Producing Animals Replaced by Guidance 152
79. Guidance for Industry 79--Dispute Resolution Procedures for Science-Based Decisions on Products
Regulated by the Center for Veterinary Medicine (CVM)--Final Guidance July 2005
80. Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds 11/21/02
82. Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs--Final
Guidance 10/28/02
83. Guidance for Industry: Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA: DRAFT
GUIDANCE 06/99
84. Guidance for Industry:Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling:
DRAFT GUIDANCE 03/99
85. Guidance for Industry: Good Clinical Practices: VICH GL9, Final Guidance 05/09/01
86. Guidance for Industry--How to Submit a Notice of Final Disposition of Investigational Animals Not Intended
for Immediate Slaughter in Electronic Format by E-Mail 1/17/06
87. Guidance for Industry--How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic
Format by E-mail 01/17/06
88. Guidance for Industry--How to Submit a Request for a Meeting or Teleconference in Electronic Format by E-
mail 01/17/06
89. Guidance for Industry--Environmental Impact Assessments (EIA's) For Veterinary Medicinal Products (VMP's)--
Phase I, VICH GL6: Final Guidance 03/07/01
90. Guidance for Industry--Effectiveness of Anthelmintics: General Recommendations, Final Guidance--VICH GL7
(replaces 3/26/2001) 10/11/01
91. Guidance for Industry: International Cooperation on Harmonisation of Technical Requirements for Approval of
Veterinary Medicinal products (VICH); Final Guidance on Stability Testing for Medicated Premixes (VICH GL8);
Availability 03/00
92. Guidance for Industry 92: Impurities In New Veterinary Drug Substances (Revision), VICH GL10 ( R) ,
Draft Revised Guidance, January 5, 2006 01/05/06
93. Guidance for Industry 93--Impurities in New Veterinary Medicinal Products (Revised), Draft Revised
Guidance--VICH GL11 (R), January 10, 2006 01/10/05
95. Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Bovines: VICH GL12, Final
Guidance 03/26/01
96. Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Ovines: VICH GL13, Final
Guidance 03/26/01
97. Guidance for Industry: Efficacy Of Anthelmintics: Specific Recommendations for Caprines: VICH GL14, Final
Guidance 03/26/01
98. Dioxin In Anti-Caking Agents Used In Animal Feed And Feed Ingredients Revised 04/14/00
99. Guidance for Industry: Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products--
VICH GL17--Final Guidance 03/26/01
100. Guidance for Industry: Impurities: Residual Solvents in New Veterinary Medicinal Products, Active
Substances and Excipients: VICH GL18, Final Guidance 05/15/01
102. Guidance for Industry: ``Manufacture and Distribution of Unapproved Piperazine Products''--Revised 08/99
103. Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products 08/99
104. Guidance for Industry: Content and Format of Effectiveness and Target Animal Safety Technical Sections and
Final Study Reports For Submission to the Division of Therapeutic Drugs for Non-Food Animals 07/10/01
105. Draft Guidance for Industry: Computerized Systems Used in Clinical Trials, Revision 1, Erratum, September
2004 09/04
106. The Use of Published Literature in Support of New Animal Drug Approval 08/31/00
107. Guidance for Industry: How to Submit a Protocol in Electronic Format by E-Mail 01/17/06
108. Guidance for Industry: How to Submit Information in Electronic Format by E-Mail 01/17/06
109. Guidance for Industry 109: Effectiveness of Anthelmintics: Specific Recommendations for Equine--
VICH GL15--Final Guidance 06/27/02
110. Guidance for Industry 110: Effectiveness of Anthelmintics: Specific Recommendations for Porcine--
VICH GL16--Final Guidance 06/27/02
111. Guidance for Industry 111: Effectiveness of Anthelmintics: Specific Recommendations for Canine--
VICH GL19--Final Guidance 06/27/02
112. Guidance For Industry 112 : Fumonisin Levels in Human Foods and Animal Feeds--Final Guidance 11/09/01
113. Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Feline--VICH GL20--
Final Guidance 06/19/02
114. Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus--
VICH GL21--Final Guidance 06/19/02
[[Page 15460]]
115. Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies--
VICH GL22--Final Guidance 01/03/02
116. Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Genotoxicity Testing--VICH GL23--Final Guidance 01/03/02
117. Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event
Reports (AER's)--VICH GL24--DRAFT GUIDANCE 12/12/00
118. Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues--Final
Guidance 05/01/03
119. Guidance for Industry and Reviewers: How the Center for Veterinary Medicine Intends to Handle Deficient
Submissions Filed During the Investigation of a New Animal Drug--Final Guidance 08/29/02
120. Guidance for Industry 120--Veterinary Feed Directive Regulation 03/01/01
121. Guidance for Industry 121: Expedited Review for New Animal Drug Applications for Human Pathogen
Reduction Claims 03/06/01
122. Guidance for Industry: Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion
Carnivores and Omnivores, May 18, 2004 Revised 11/09/04
123. Guidance for Industry 123--Development of Target Animal Safety and Effectiveness Data to Support Approval
of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for Use in Animals, Final, January 5, 2006 01/05/06
124. Guidance for Industry 124: Voluntary Labeling Indicating Whether Foods Have or Have Not Been
Developed Using Bioengineering--Draft 01/17/01
126. Guidance for Industry 126--BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives
Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation, February 2001 02/01
132. Guidance for Industry: The Administrative New Animal Drug Application Process--Draft 11/06/02
135. Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds, Final 11/07/05
141. Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Carcinogenicity Testing, VICH GL28, Final Guidance 05/24/04
142. CVM Guidance for Industry 142: Pharmacovigilance of Veterinary Medicinal Products: Management of
Periodic Summary Update Reports (PSUs)--VICH GL29--Draft Guidance 12/12/01
143. CVM Guidance for Industry 143: Pharmacovigilance of Veterinary Medicinal Products: Controlled List
of Terms--VICH GL30--Draft Guidance 02/01/02
144. Guidance for Industry: Pre-Approval Information for Registration of New Veterinary Medicinal Products for
Food-Producing Animals with Respect to Antimicrobial Resistance--VICH GL27, Final Guidance 04/27/04
145. Bioanalytical Method Validation 05/01
147. Guidance for Industry 147--Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Repeat-Dose (90-Day) Toxicity Testing--VICH GL31, 11/12/03
148. Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Developmental Toxicity Testing--VICH GL32 Final Guidance 03/19/04
149. Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
General Approach to Testing VICH GL33 05/18/04
150. Guidance for Industry: Status of Clove Oil and Eugenol for Anesthesia of Fish 06/11/02
151. Guidance for Industry: FDA Export Certificates 07/04
152. Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their
Microbiological Effects on Bacteria of Human Health Concern 10/23/03
153. Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for
Use in Humans and Animals 09/02
154. Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of
Electronic Records Withdrawn 02/25/03
155. Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies
of Electronic Records Withdrawn 02/04/03
156. Draft Guidance for Industry: Comparability Protocols--Chemistry, Manufacturing, and Controls Information;
Availability 02/03
157. Guidance for Industry: Part 11, Electronic Records, Electronic Signatures--Scope and Application 08/03
158. Guidance for Industry--Use of Material from Deer and Elk in Animal Feed 09/15/03
159. Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
General Approach to Establish a Microbiological ADI--VICH GL-36, Final Guidance 02/10/05
160. Guidance for Industry--Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-
Dose (Chronic) Toxicity Testing, VICH GL-37--Final Guidance 02/07/05
162. Draft Guidance for Industry--Comparability Protocols--Protein Drug Products and Biological Products--
Chemistry, Manufacturing, and Controls Information 09/03
163. Draft Guidance for Industry : Formal Dispute Resolution: Scientific and Technical Issues Related to
Pharmaceutical CGMP 08/03
164. Guidance for Industry--PAT--A Framework for Innovative Pharmaceutical Development, Manufacturing, and
Quality Assurance, September 2004 09/04
165. Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations
10/03
166. Guidance for Industry--Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMPs),
Phase II, Final Guidance, VICH GL38, 01/09/06
167. Guidance for Industry: Prior Notice of Imported Food Questions and Answers 12/12/03
168. Guidance to Industry: Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior
Notice Indicators 11/20/03
169. Guidance for Industry: Drug Substance: Chemistry, Manufacturing, and Controls Information, Draft Guidance
01/04
170. Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance, March 15, 2004
03/15/04
171. Guidance for Industry on Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble
Powder Oral Dosage Form Products and Type A Medicated Articles; Availability (Notice) 02/16/06
172. Guidance for Industry 172--Use of unapproved hormone implants in veal calves, April 2, 2004
Withdrawn 07/15/04
173. Guidance for Industry--Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA) Appendix 02/07/
05
174. Guidance for Industry--Use of Material from BSE Positive Cattle in Animal Feed 09/30/04
176. Guidance for Industry 176--Specifications: Test Procedures and Acceptance Criteria for New
Veterinary Drug Substances and New Medicinal Products: Chemical Substances--VICH GL-39, Draft Guidance--May 24,
2005 05/24/05
177. Guidance for Industry 177--Specifications: Test Procedures and Acceptance Criteria for New
Biotechnological/Biological Veterinary Medicinal Products--VICH GL-40, Draft Guidance--May 24, 2005 05/24/05
----------------------------------------------------------------------------------------------------------------
[[Page 15461]]
VII. Office of the Commissioner/Office of Policy (OC/OP)
For information on a specific guidance document or to obtain a hard
copy, contact:
For guidance documents pertaining to Good Clinical Practices: Good
Clinical Practices Program, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-3340, http:///www.fda.gov/oc/gcp/guidance.html
.
For other guidance documents listed under OC/OP: Office of Policy,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-3360, http://www.fda.gov/opacom/morechoices/industry/guidedc.html
.
No OC/OP guidance documents were withdrawn from January 5, 2005, to
January 5, 2006.
The following is a copy of a list of current OC/OP guidance
documents obtained from the FDA Web site as of March 14, 2006.
OC/OP Guidance Documents (obtained from the FDA Web site on March 14, 2006)
Office of the Commissioner:
----------------------------------------------------------------------------------------------------------------
Draft Guidance: Using Electronic Means to Distribute Certain Product Information
Draft Guidance; Emergency Use Authorization of Medical Products
Conflict of Interest Disclosure Guidance
Small Business Guide to FDA
FDA Guidance--Financial Disclosure by Clinical Investigators, March 20, 2001
FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996
(Federal Register June 12, 1998)
Guidance for FDA and Industry: Direct Final Rule Procedures (Federal Register Nov. 21, 1997)
Final Guidance on Industry-Supported Scientific and Educational Activities (Federal Register Dec. 3, 1997)
----------------------------------------------------------------------------------------------------------------
Guidances and Information Sheets on Good Clinical Practice in FDA-Regulated Clinical Trials
----------------------------------------------------------------------------------------------------------------
Guidances
FDA Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject
Protection
Guidance for Industry: Acceptance of Foreign Clinical Studies
Guidance for Industry: Available Therapy
Guidance for Industry: Computerized Systems Used in Clinical Trials
Guidance for Industry: Development and Use of Risk Minimization Action Plans
Guidance for Industry Exploratory IND Studies
Guidance for Industry: Financial Disclosure by Clinical Investigators
Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies
Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
Guidance for Industry: Guideline for the Monitoring of Clinical Investigators
Guidance for Industry: Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation
of Drugs
Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples;
Availability
Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biologicial Products for the
Treatment of Cancer
Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions
Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations
Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application
Guidance on Pharmacogenomic Data Submissions
Guidance for Premarketing Risk Assessment
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications
Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator
Misconduct
----------------------------------------------------------------------------------------------------------------
ICH Guidances
----------------------------------------------------------------------------------------------------------------
ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports
ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data
ICH E6: Good Clinical Practice: Consolidated Guidance
ICH E10: Choice of Control Group and Related Issues in Clinical Trials
----------------------------------------------------------------------------------------------------------------
VIII. Office of Regulatory Affairs (ORA)
For information on a specific guidance document or to obtain a hard
copy, contact: Office of Executive Operations, Office of Regulatory
Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, http://www.fda.gov/ora.
The following is a list of ORA guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
------------------------------------------------------------------------
CPG--Sec. 160.800 Year 2000 (Y2K) April 26, 1999 March 8, 2005
Computer Compliance (CPG 7153.15)
------------------------------------------------------------------------
CPG--Sec. 355.100 Cellutron Machine May 31, 1990 March 10, 2005
(CPG 7124.03)
------------------------------------------------------------------------
CPG--Sec. 460.700 Controlled Release January 1, August 19, 2005
Dosage Form Drugs--Rate of Release of 1973
Active Ingredients (CPG 7132a.02)
------------------------------------------------------------------------
[[Page 15462]]
The following is a copy of a list of current ORA guidance documents
obtained from the FDA Web site as of March 14, 2006.
ORA Guidance Documents (obtained from the FDA Web site on March 14, 2006)
Industry Assistance Reference
FDA contact sources for industry assistance and inquiries.
----------------------------------------------------------------------------------------------------------------
Medical Devices--Division of Small Manufacturers , International and Consumer Assistance (DSMICA)
Quality Systems/Good Manufacturing Practices Survey/Report
FDA Small Business Program Office
Regional Small Business Representatives
A Small Business Guide to FDA
FDA Industry focus page
Code of Federal Regulations
FDA Public Workshops
----------------------------------------------------------------------------------------------------------------
ORA Science Reference
Information related to the locations of the components, ORA laboratory, laboratory procedures, new techniques
and useful analytical findings in support of FDA regulatory activities. ORA Science References are available
for the following:
----------------------------------------------------------------------------------------------------------------
TOTAL DIET AND PESTICIDE RESEARCH CENTER--Information and materials relating to the FDA Total Diet Study
Research.
LABORATORY MANUAL 2004--Agency policy for testing consumer products, training of laboratory staff, report
writing, safety, research, review of private laboratory reports and court testimony. (Formerly: Laboratory
Procedure Manual)
LABORATORY INFORMATION BULLETINS--Samples of collection of more than 3,000 bulletins describing new techniques
and useful analytical findings by ORA laboratories in support of FDA regulatory activities.
PRIVATE LABORATORIES--Information concerning private laboratories and activities are included in this section.
----------------------------------------------------------------------------------------------------------------
ORA Compliance Reference
Revisions and Update List
----------------------------------------------------------------------------------------------------------------
Recent:
03/08/2006: Revised list to add 1 new member, Restricted List for Clinical Investigators
02/09/2006: Updated the program contact person (s) information on the following pages:
http://www.fda.gov/ora/compliance_ref/bimo/default.htm http://www.fda.gov/ora/compliance_ref/bimo/background.html
ance_ref/bimo/background.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
01/19/2006: Change in classification (Class)--Pine Acres Research Facility, Norton, MA
01/11/2006: Updated list to remove restriction for 1 member. Restricted List for Clinical Investigators
12/29/2005: Revised Restricted List for Clinical Investigators to add 1 new member
12/21/2005: Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990. Updated December 09,
2005 Edited list to correct typographical error in the initial of Dr. Farber on Disqualified/Totally
Restricted List for Clinical Investigators Updated ``FDA AIP Contacts List'' (December 2005) on the
Application Integrity Policy Information page
12/12/2005: Revised CPG Sec. 230.150--Blood Donor Classification Statement, Paid or Volunteer Donor Revised
CPG Sec. 300.750--Class III Devices Subject to 515(b) Requirements (CPG 7124.18) Revoked CPG Sec. 460.700--
Controlled Release Dosage Form Drugs--Rate of Release of Active Ingredients (CPG 7132a.02)
12/06/2005: Updated list to remove restriction for 1 member, 11/23/2005: Restricted List for Clinical
Investigators
12/01/2005: Updated ``FDA AIP Contacts List'' (August 2005) on the Application Integrity Policy Information
page
11/29/2005: Edited Compliance Policy Guides Sec. 160.100 and 118 pages in Chapter 5 to reflect FDA
organization and contact changes.
11/18/2005: Added on-line link for compliance program 7385.014, Mammography Facility Inspections. Revised list
to add 1 new member on Disqualified/Totally Restricted List for Clinical Investigators
11/14/2005: Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
11/10/2005: Revised CPG Sec. 110.310--Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
11/03/2005: Revised list to remove one member from the Application Integrity Policy List
10/31/2005: Revised http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm to add one person and update the
list contact person. Also, the contact person was updated on:
http://www.fda.gov/ora/compliance_ref/bimo/asurlist.htm http://www.fda.gov/ora/compliance_ref/bimo/restlist.htm
iance_ref/bimo/restlist.htm
09/15/2005: Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated September 15,
2005
09/13/2005: Revised list to remove one member on the Application Integrity Policy List
08/08/2005: Revoked by Federal Register notice on 09/24/1998 (63 FR 51074), CPG Sec. 615.100 Extra-Label Use
of New Animal Drugs in Food-Producing Animals (CPG 7125.06)
08/04/2005: Updated the program contact person(s) information on the following pages:
http://www.fda.gov/ora/compliance_ref/bimo/default.htm http://www.fda.gov/ora/compliance_ref/bimo/background.html
ance_ref/bimo/background.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_intro.htm (and related GLP lists)
08/02/2005: Table for Veterinary Medicine compliance programs is updated to reflect on-line documents and/or
information now supplied by the Center for Veterinary Medicine.
07/28/2005: Revised Debarment List, 07/28/2005--One person added.
07/18/2005: Re-numbered existing biologics compliance program 7341.002 ``Inspection of Tissue Establishments''
to 7341.002A and added new biologics compliance program 7341.002 ``Inspection of Human Cells, Tissues, and
Cellular and Tissue-based Products (HCT/Ps).''
5/31/2005 Draft revised CPG Sec. 480-200--Expiration Dating of Unit-Dose Repackaged Drugs (CPG 7132b.11)
Notice of Availability Draft Guidance
05/20/2005: Revised list to add 1 new member, Restricted List for Clinical Investigators
05/19/2005: Revised CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG 7124.07)
05/17/2005: Revised list to add 1 new member, Restricted List for Clinical Investigators
[[Page 15463]]
05/05/2005: Added new biologics compliance program 7345.848 Inspection of Biological Drug Products, and
removed four programs that the new program supersedes: 7341.001, 7342.006, 7345.001, and 7345.002.
04/25/2005 Revised CPG 100.700 GWQAP Pre-Award Evaluation--Inadequate Information to Evaluate Prospective
Supplier
04/25/2005 Revised CPG 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic
Products
04/18/2005: Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated April 18,
2005
04/13/2005 Revised CPG Sec. 560.400 Imported Milk and Cream--Federal Import Milk Act CPG 7119.05
04/12/2005: Revised Debarment List, 04/12/2005--One person added.
04/11/2005: Revised list to add 3 new members, Restricted List for Clinical Investigators
03/23/2005 Revised list to add one new member; and remove one Application Integrity Policy List
03/18/2005 Revised CPG Sec. 300.500--Reprocessing of Single Use Devices (CPG 7124.16)
03/10/2005 Revised 8 CPGs to make corrections/minor changes: Sec. 390.100; Sec. 390.400; Sec. 393.100; Sec.
396.300; Sec. 398.100; Sec. 398.325; Sec. 398.425; Sec. 398.700;
03/10/2005 Revoked CPG: Sec. 355.100--Cellutron Machine
03/08/2005 Revoked 03/08/2005, Compliance Policy Guide, Sec. 160.800 Y2K Computer Compliance
03/08/2005: Revised list to add 2 new members, Restricted List for Clinical Investigators
03/04/2005: Revised CPG Sec. 110.310--Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
02/18/2005: Draft revised CPG Sec. 310.210 ``Blood Pressure Measurement Devices (Sphygmomanometers)--Accuracy
(CPG 7124.23) FR Notice of Availability Draft Revision
02/01/2005: Revised list to add 1 new member, Restricted List for Clinical Investigators
01/14/2005: Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
2004 Revisions and Updates:
12/07/2004 Revised Debarment List, 12/07/2004--One person added. Published 12/02/2004.
11/18/2004 Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated November 18,
2004
11/16/2004 New CPG Sec. 400.210--Radiofrequency Identification Feasibility Studies and Pilot Programs
11/03/2004 Revised CPG Sec. 110.300--Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
11/02/2004 Revised CPG Sec. 110.310--Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
10/29/2004 Draft CPG (Not for Implementation), Sec. 560.400 ``Imported Milk and Cream--Federal Import Milk Act
(CPG 7119.05).'' When finalized it will replace the existing CPG at Sec. 560.400. Comments due 30 days after
date of publication in the Federal Register dated October 29, 2004
10/03/2004 Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators
08/31/2004 Edited Debarment List--at Uddin, Mohammad, added ``NMI'' to indicate that FDA records show no
middle initial for this person.
08/16/2004 Revised CPG Sec. 110.310--Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
07/29/2004 Revised CPG Sec. 394.500--Importation of Television Products, Microwave Ovens, and Inherent Class I
Laser Products for Investigation and Evaluation
07/29/2004 Replaced/Retitled CPG Sec. 560.750 Guidance Levels for Radionuclides in Domestic and Imported Foods
(CPG 7119.14)
07/23/2004 Updated links to FDA Regulations (2004) on the Bioresearch Monitoring Information Page; links to
laws enforced by FDA and related regulation on the Welcome to Compliance References page
06/24/2004 Revised CPG Sec. 110.310--Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
06/16/2004 AIP Procedures--procedures March 5, 1998
06/10/2004 Revised to update citations Sec. 690.300 Canned Pet Food (CPG 7126.18)
06/15/2004 Correction in classification (Class)--Charles River Laboratories, West Chester, OH
05/12/2004 John B. Najarian on Restricted List for Clinical Investigators
05/06/2004 March 2004 edition of the Regulatory Procedures Manual (RPM) published. New edition of FDA RPM is
effective May 6th, 2004. All chapters have been changed except Chapter 9 ``Import Operations/Actions.''
04/09/2004 Corrected entry for Arthur Riba on Restricted List for Clinical Investigators
04/05/2004 Revised Application Integrity Policy List to add Plus Orthopedics, San Diego, California.
3/12/2004 Revised to update content of August 2000 paper edition: Sec. 490.100 Process Validation Requirements
for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval CPG 7132c.08
02/23/2004 Revised list to add 1 new member, 02/23/2004: Restricted List for Clinical Investigators; Revised
list to add 1 new member, 02/23/2004: Disqualified/Totally Restricted List for Clinical Investigators
02/13/2004 Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated February 9,
2004
2/9/2004 Edited two pages to conform text (reference) on Internet pages to August 2000 paper edition: CPG Sec.
515.700 Chocolate & Chocolate Liquor--Adulteration with Insect and Rodent Filth CPG 7105.11 CPG Sec. 515.775
Cocoa Powder, Press Cake--Adulteration with Insect and Rodent Filth CPG 7105.13
Draft CPG 1/14/2004 Draft CPG (Not for Implementation), Sec. 560.750 ``Guidance Levels for Radionuclides in
Domestic and Imported Foods, Availability; and Draft Supporting Document, Supporting Document for Guidance
Levels for Radionuclides in Domestic and Imported Foods.'' When finalized it will replace the existing CPG.
Comments due March 15, 2004--The Draft Guidance--The Draft Guidance--Supporting Statement for Guidance
Levels--Supporting Statement for Guidance Levels
Revoked 1/5/2004 Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse CPG 7124.06
2003 Revisions and Updates:
New CPG Sec. 110.300--``Registration of Food Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002'' is available at: http://www.cfsan.fda.gov/~furls/cpgreg.html.
Revised: Application Integrity Policy Committee Contact Persons list on 12/18/2003
Revised Application Integrity Policy List to add AGA Medical Corporation, Golden Valley, Minnesota
[[Page 15464]]
Revised CPGM list on 12/18/2003 by added new Drugs program 7356.002M, ``Inspections of Licensed
Biological Therapeutic Drug Products'' added new Veterinary Medicine program 7371.009, ``BSE/
Ruminant Feed Ban Inspections'' added on-line links for Drug programs: 7346.832 ``Pre-Approval
Inspections/Investigations''; 7346.843, ``Post-Approval Audit Inspections''; 7356.002A, ``Sterile Drug
Process Inspections''; 7356.002B, ``Repackers and Relabelers'', 7356.002C, ``Radioactive drugs'' and
7356.002E, ``Compressed medical gases'' Corrected title of drug program 7356.002 ``Drug
Manufacturing Inspections'' corrected CPGM list by removing previously withdrawn Device programs
7385.002 ``Ionizing Radiation Use Control Laboratory Support'', 7385.003 ``Federal Facility Use Control and
Equipment Performance Survey Program'', and 7386.006G ``WEAC Testing of Medical Devices for Conformance to
Voluntary Standards'' corrected Device program numbers 7382.014 to 7385.014 and 7385.004 to
7386.009.
New CPG Sec. 110.310--``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002'' is available at: http://www.cfsan.fda.gov/~pn/cpgpn.html.
Revised Debarment List, 10/22/2003--One person added. Published 10/23/03.
Revised list to add 2 new members, 10/17/2003: Disqualified/Totally Restricted List for Clinical
Investigators. Published 10/21/03.
Revised Debarment List, 10/10/2003--debarment terminated for one person; three people added. Published 10/10/
03.
Added pdf version of Guideline for the Monitoring of Clinical Investigations, Jan., 1988. Published 9/30/03.
Revised list to add 2 new members, 09/09/2003: Restricted List for Clinical Investigators. Published 09/10/03.
Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 08/11/2003. Published 09/
04/03.
Revised Debarment List, 8/8/2003--one person added. Published 8/15/03.
Revised Sec. 608.400--Compounding of Drugs for Use in Animals. Published 7/14/03.
Revised 3 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 01/27/3. Published 7/2/
03.
New CPGM link to Compliance Programs published by CBER: Inspection of Source Plasma Establishments and
Inspections of Licensed Vaccines. Published 6/6/03.
Updated ORA page on Electronic Records/Signatures, 21 CFR Part 11. Published 6/6/03.
Revised Debarment List, 5/9/2003--one person added. Published 5/30/03.
Revoked effective 02/19/2003: Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records;
Electronic Signatures (CPG 7153.17). See: 68 FR 8775 02/25/2003. Published 5/30/03.
Revised list to update Dr. J.L. Williams, 5/15/2003: Disqualified/Totally Restricted List for Clinical
Investigators. Published 5/23/03.
Replaced Reference: Good Laboratory Practice (GLP) Final Rule, 12/22/1978. Published 5/23/03.
Revised--Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 03/06/2003.
Published 5/1/03.
Revised Application Integrity Policy List to remove Gliatech, Inc., Beachwood, OH; and Solvay Pharmaceuticals,
Inc., Beaudette, MN, and Marietta, GA, April 2003.
Revised list to add new member, 04/10/2003: Disqualified/Totally Restricted List for Clinical Investigators.
Revised Debarment List on 04/09/2003--One person removed (Hernandez, Delfina); One correction inserted (Lai,
Elaine).
Revised: Application Integrity Policy Committee Contact Persons list. Updated 3/31/2003.
Revised 03/23/2003, HTML/online links changed for Biologics Compliance Programs 7342.006, 7342.008. and
7345.001 (CBER). No content was changed.
New CPGM, 03/19/2003: Biologics Compliance Program March 2003, 7341.002, Inspection of Tissue Establishments
(CBER).
Revoked effective 02/19/2003--Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records;
Electronic Signatures (CPG 7153.17) See: 68 FR 8775 02/25/2003.
Revised list to add new member, 02/10/2003: Disqualified/Totally Restricted List for Clinical Investigators.
Revised Debarment List on 01/13/2003--2 people added.
2002 Revisions and Updates
Revised list to add new member, 10/28/2002: Disqualified/Totally Restricted List for Clinical Investigators.
Edited lists 12/16/2002: 1) Inactive Labs List and 2)Active Tox Labs List
Revised Debarment List on 12/03/2002--one person added
Typographical errors (1 per page) 11/27/2002: CPGuides Manual--Sec 555.425--Foods--Adulteration Involving Hard
or Sharp Foreign Objects; and Sec. 515.350 Candy--Mixed with Trinkets and Sold in Vending Machines (CPG
7105.04)
Edited links 11/27/2002: 21 CFR Part 11 Guidance Documents Dockets Established--Topics for Guidance
Development Revised 11/14/2002: Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG
7120.18)
Updated 11/14/2002: 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990
Revoked effective 11/12/2002: Sec. 398.475 Minimum X-Ray Field Size for Spot-Film Operation of Fluoroscopic
Systems with Fixed SID and Without Stepless Adjustment of the Field Size (CPG 7133.17)
Revised 11/13/2002 Debarment List--3 people added
Revised 2 lists to add new or update member(s), 10/16/2002: Disqualified/Totally Restricted List for Clinical
Investigators and Restricted List for Clinical Investigators
Revoked effective 10/07/2002, Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a
Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (CPG 7124.30) per Federal
Register, 09/05/2002 (67 FR 56850)
Revised Subchapter Import for Export in Chapter 9 of Regulatory Procedures Manual. 09/13/2002.
New--CryoLife, Inc., Kennesaw, GA, 08/13/2002. Order for Retention, Recall, and/or Destruction
New--Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990. Updated 08/2002
Revised list to add new member, 08/7/2002: Disqualified/Totally Restricted List for Clinical Investigators
Revoked effective on 08/07/2002: Sec. 315.200 Status of Dental Supplies such as Denture Cleaners, Adhesives,
Cushions, and Repair Materials as a Device or Cosmetic (CPG 7124.05) See 67 FR 45129, 07/08/2002
Revised list to add new member, 06/27/2002: Restricted List for Clinical Investigators
Revised list to add new member, 06/27/2002: Disqualified/Totally Restricted List for Clinical Investigators
Reissued 05/29/2002, Sec. 460.200 Pharmacy Compounding
Revoked effective on 06/20/2002, Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor
Discharge Lamps (CPG 7133.13)
Revoked effective on 06/20/2002, Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning
Products (CPG 7133.16)
Corrected 05/16/2002, Sec 575.100 Pesticide Residues...Heptachlor table
New CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor issued 05/07/2002
Revised BioResearch Monitoring Information references added or updated 05/16/2002
Revised Debarment List on 05/07/2002--person added
Revised Compliance Program Manual 04/26/2002 page--page text and links were updated
Edited Debarment List on 04/09/2002
[[Page 15465]]
Revised as Draft 05/29/2002--Sec. 345.100 Male Condom Defects (CPG 7124.21) for comment
Edited page to remove dates that may become obsolete, 04/2/2002: Application Integrity Policy Information.
Revised list to add new member, 04/02/2002: Disqualified/Totally Restricted List for Clinical Investigators
Revised list to add new member, 02/20/2002: Application Integrity Policy List
Revised lists to align members to groups, 01/15/2002: a) Restricted List for Clinical Investigators b)
Disqualified/Totally Restricted List for Clinical Investigators
2001 Revisions and Updates
Revised as Draft Dec 18, 2001--Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG
7120.18)
New CPG Oct., 2001--Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products--Adulteration
with Patulin
Reformat CPG Oct., 2001--Sec. 570.425 Tree Nuts--Adulteration Involving Rejects (Insect Infestation, Moldy,
Rancid, Otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05)
Final CPG April 2001--Sec. 615.115 Extra-Label Use of Medicated Feeds for Minor Species
New CPG April 2001, Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food
Allergens
New RPM Chapter 5, March, 2001, Subchapter Civil Money Penalties, Reduction of Civil Money Penalties for Small
Entities
New RPM Chapter 9, January 2001, Communication Concerning Assessment of Civil Monetary Penalties by U.S.
Customs Service in Cases Involving Imported Food
New RPM Chapter 9, January 2001, Secured Storage
2000 Revisions and Updates
Draft CPG--December 2000, Sec. 230.150 Blood Donor Incentives
Revised 8/10/2000, Sec. 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (CPG
7108.17)
New 06/29/2000, Sec. 100.950 International Parnership Agreements for Compliance Activities--Agreements among
the USFDA, Foreign Government Agencies, and Foreign or Domestic Trade Associations and/or Other Organizations
Deleted 07/03/2000, Sec. 405.100 Prescriptions Prepared from Certified Antibiotics (CPG 7122.01)
Deleted 07/03/2000, Sec. 405.200 Export of Uncertified Antibiotics (CPG 7122.02)
Deleted 07/03/2000, Sec. 405.210 Returned Antibiotics Exported Under 801(d) of the Act (CPG 7122.03)
Revised 05/01/2000, Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18)
Revised 04/14/2000, Section 110.100, Certification for Exports (CPG7150.01)
Deleted 03/28/2000, Section 215.100, IND Filings: Completion of Applicable...
Reissued 03/22/2000, Section 257.100, Deferral of Source Plasma Donors Due to Red Cell Loss During Collection
of Source Plasma by Automated Plasmapheresis
New 03/06/2000, Section 252.110, Volume Limits for Automated Collection of Source Plasma
Deleted (Revoked) 01/24/2000, Sec. 305.100 Acupuncture Devices and Accessories (CPG 7124.11)
1999 Revisions and Updates
Draft CPG--08/04/1999, Section 615.115 Use of Medicated Feeds for Minor Species
July 9, 1999, Compliance Policy Guide 230.140, Biologics, Evaluation and Processing Post Donation Information
Reports
The ``Draft Civil Money Penalty Reduction Policy for Small Entities'' published in the Federal Register (FR)
on May 18, 1999. See final copy of the RPM Subchapter March 20, 2001
New 5/13/1999, Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic
Signatures (CPG 7153.17)
New, 4/26/1999, Compliance Policy Guide, Y2K Computer Compliance
Draft Revised CPG, 4/9/1999, Regulatory Policy on the Disposition of Publications that Constitute Labeling
(CPG 7153.13) (Level I guidance document (see 62FR8961 2/27/97)) Not for Implementation
----------------------------------------------------------------------------------------------------------------
Welcome to Inspection Reference
This page includes information provided to FDA investigators and inspectors to assist them in their daily
activities.
----------------------------------------------------------------------------------------------------------------
Field Management Directives--The primary vehicle for distributing procedural information/policy on the
management of Office of Regulatory Affairs (ORA) field activities.
Guides to Inspections of...--Guidance documents written to assist FDA personnel in applying FDA's regulations,
policies and procedures during specific types of inspection or for specific manufacturing processes. Note:
These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA
and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative
approach may be used if such an approach satisfies the applicable statutes, regulations or both. Updated: June
2005
BIOTECHNOLOGY
BIOTECHNOLOGY INSPECTION GUIDE (11/91)
BIOLOGICS
BLOOD BANKS (9/94)
SOURCE PLASMA ESTABLISHMENTS (Rev 4/01)
INFECTIOUS DISEASE MARKER TESTING FACILITIES (6/96)
VIRAL CLEARANCE PROCESSES FOR PLASMA DERIVATIVES
COMPUTER ISSUES
COMPUTERIZED SYSTEMS IN DRUG ESTABLISHMENTS (2/83)
COMPUTERIZED SYSTEM IN THE FOOD PROCESSING INDUSTRY
GLOSSARY COMP. SYSTEMS. SOFTWARE DEVELOPMENT TERMINOLOGY (8/95)
DEVICES
QUALITY SYSTEMS
ELECTROMAGNECTIC COMPATIBILITY ASPECTS OF MEDICAL DEVICE QUALITY SYSTEMS
BIORESEARCH MONITORING INSPECTIONS OF IN VITRO DIAGNOSTIC DEVICES
MAMMOGRAPHY QUALITY STANDARDS ACT AUDITOR'S GUIDE
MEDICAL DEVICE MANUFACTURERS
DRUGS
BULK PHARMACEUTICAL CHEMICALS (9/91)
HIGH PURITY WATER SYSTEMS (7/93)
LYOPHILIZATION OF PARENTERALS (7/93)
MICROBIOLOGICAL. PHARMACEUTICAL QUALITY CONTROL LABS (7/93)
PHARMACEUTICAL QUALITY CONTROL LABORATORIES (7/93)
[[Page 15466]]
VALIDATION OF CLEANING PROCESSES (7/93)
DOSAGE FORM DRUG MANUFACTURERS--CGMP'S (10/93)
ORAL SOLID DOSAGE FORMS PRE/POST APPR. ISSUES (1/94)
STERILE DRUG SUBSTANCE MANUFACTURERS (7/94)
TOPICAL DRUG PRODUCTS (7/94)
ORAL SOLUTIONS AND SUSPENSIONS (8/94)
FOODS COSMETICS
ALLERGY INSPECTION GUIDE (April, 2001)
ASEPTIC PROCESSING AND PACKAGING FOR THE FOOD INDUSTRY
NUTRITIONAL LABELING AND EDUCATION ACT (NLEA) REQUIREMENTS (8/94-2/95)
COSMETIC PRODUCT MANUFACTURERS (2/95)
COMPUTERIZED SYSTEMS IN THE FOOD PROCESSING INDUSTRY
GRAIN PRODUCT MANUFACTURERS
INTERSTATE CARRIERS AND SUPPORT FACILITIES (4/95)
DAIRY PRODUCT MANUFACTURERS (4/95)
MISCELLANEOUS FOOD PRODUCTS--VOL. 1 (5/95)
MISCELLANEOUS FOOD PRODUCTS--VOL. 2 (9/96)
LOW ACID CANNED FOOD MANUFACTURERS Part 1--ADMINISTRATIVE PROCEDURES/SCHEDULED PROCESSES
LOW ACID CANNED FOOD MANUFACTURERS Part 2--PROCESSES/PROCEDURES
LOW ACID CANNED FOOD MANUFACTURERS Part 3--CONTAINERS/CLOSURES (11/98)
ACIDIFIED FOOD MANUFACTURERS
TRACEBACK OF FRESH FRUITS AND VEGETABLES IMPLICATED IN EPIDEMIOLOGICAL INVESTIGATIONS
SALMONELLA ENTERITIDIS (SE) GUIDE TO TRACEBACK IN EGGS (07/03/2003)
MISCELLANEOUS
FOREIGN MEDICAL DEVICE MANUFACTURERS (9/95)
FOREIGN PHARMACEUTICAL MANUFACTURERS (5/96)
IOM: Investigations Operations Manual 2006 Centennial Edition--Primary procedure manual for FDA personnel
performing inspections and special investigations.
Guide to International Inspections and Travel--Procedure manual for FDA personnel performing inspections and
other FDA-related activities abroad.
Inspection Technical Guides--Guidance documents that provide FDA personnel with technical background in a
specific piece of equipment. or a specific manufacturing or laboratory procedure, or a specific inspectional
technique, etc.
1. Introductory IssueAll Programs 1/20/72
2. Steam Generation in Canneries Food Canneries 2/11/72
3. Steam Distribution for Retort Venting in Food Canneries Food Canneries 3/03/72
4. New Equipment Kenics Static Mixers Food, Drug and Cosmetic 3/20/72
5.Ethylene Oxide Sterilization 1. Calculation of Initial Gas Concentration Drugs, Sterile Devices 6/09/72
6. Leak Testing Sealed Ampuls of Parenteral Solutions Drugs, Human and Veterinary Injectable Vitamins 4/28/72
7. Sterilizing Symbols (D, Z, F) Low Acid Canned Foods 1/09/72
8. ``Package Unit'' Italian Flour Mills Cereal Flours & Related Products 12/14/72
9. Polariscope Sterile Packaging--Foods, Drugs, Devices, Hardened Lenses 5/21/73
10. Diathermy Medical Devices 5/21/73
11. Steam Pressure for Retorts and Autoclaves Sterile Drugs and Devices Low Acid Canned Foods, Biologics 6/29/
73
12. Stroboscope Food, Drug, Device, Manufacture and Packaging 8/08/73
13. Field Submission of Articles All Programs 9/05/73 (8/03/84 Revised)
14. Thermocouple Surface Pyrometers Food Canneries12/20/73
15. Common Valves Used in Process Fluid Systems Sterile Drugs, Devices, Low Acid Canned Foods and Biologics 1/
15/74
16. A.T.I. Steam Activated Heat Sensitive Indicators Food, Drugs, Medical Devices 3/08/74
17. New Source of Lead and Other Contamination Various Foods and Drugs 6/18/74
18. Ultrasound in the Food, Drug, and Device Industries Food, Drugs, and Medical Devices 3/03/75
19. Screening Electronic Components Medical Devices 4/20/75
20. Hermetically Sealed Electronic Component Leak Detection Medical Devices 7/18/75
21. Noise Control Mufflers for Bleeders on Retorts and Sterilizers Food, Drugs 9/15/75
22. Ground Fault Circuit Interrupter All Programs, Personnel Safety 3/05/76
23. The Computer in FDA Regulated Industries Foods, Drugs, and Medical Devices 5/21/76
24. Air Velocity Meters Sterile Drugs and Devices, Foods and Cosmetics 7/30/76
25. Ethylene Oxide Sterilization 2. Graphical Aid to Determine Gas Concentration Sterile Devices, Drugs 9/01/
76
26. Evaluation of Production Cleaning Processes for Electronic Medical Devices--Part 1, Contaminants Medical
Devices 1/07/77
27. Evaluation of Production Cleaning Processes for Electronic Medical Devices--Part II, Cleaning Solvents
Medical Devices 1/07/77
28. Evaluation of Production Cleaning Processes for Electronic Medical Devices--Part III, Methods Medical
Devices 1/07/77
29. The Computer in FDA Regulated Industries--Part II Computer Hardware All Programs 9/22/77
30. The Nation is Going Metric (rescinded) All Programs 12/02/77
31. Electronic Components--Resistors Medical Devices, Radiological Health 1/16/78
32. Pyrogens, Still a Danger Parenterals, Biologicals, Devices, Drugs 1/12/79
33. Use of the Texas Instruments Model 59 Programmable Calculator in the Enforcement of the Diagnostic X-ray
Performance Standard X-Ray Field Testing 7/12/79
34. Heat Exchangers to Avoid Contamination Drugs, Diagnostic Products Biologics 7/31/79
35. Reliability of Manufactured Products Medical Device, Radiological Health Products 9/26/80
36. Reverse Osmosis Drugs, Medical Devices and Diagnostic Products 10/21/80
37. Temperature Sensors in the Regulated Industry Foods, Drugs, Biologics, Medical Devices and Diagnostic
Products 1/7/83
38. Industrial Applications of New Biochemical Technolgy All Programs 8/1/83
39. Water Activity (a{{w{time} {time} ) in Foods Foods 4/16/84
40. Bacterial Endotoxins/Pyrogens Drugs and Devices 3/20/85
41. Expiration Dating and Stability Testing for Human Drug Products Drugs 10/18/85
http://www.fda.gov/ora/compliance_ref/bimo/background.html http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
w.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_intro.htm (and related GLP lists)
t_intro.htm">http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_intro.htmist_intro.htm (and related GLP lists) (and related GLP lists)
08/02/2005: Table for Veterinary Medicine compliance programs is updated to reflect on-line documents and/or
information now supplied by the Center for Veterinary Medicine.
07/28/2005: Revised Debarment List, 07/28/2005--One person added.
07/18/2005: Re-numbered existing biologics compliance program 7341.002 ``Inspection of Tissue Establishments''
to 7341.002A and added new biologics compliance program 7341.002 ``Inspection of Human Cells, Tissues, and
Cellular and Tissue-based Products (HCT/Ps).''
5/31/2005 Draft revised CPG Sec. 480-200--Expiration Dating of Unit-Dose Repackaged Drugs (CPG 7132b.11)
Notice of Availability Draft Guidance
05/20/2005: Revised list to add 1 new member, Restricted List for Clinical Investigators
05/19/2005: Revised CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG 7124.07)
05/17/2005: Revised list to add 1 new member, Restricted List for Clinical Investigators
[[Page 15467]]
42. Tin Whiskers--Problems, Causes, and Solutions Medical Devices 3/14/86
43. Lyophilization of Parenterals Drugs, Biologics, Diagnostics 4/18/86
44. Radiation Protection Terminology Foods 5/15/86
45. Circular Temperature Recording Chart Measurements All Programs 2/20/87
46. Water for Pharmaceutical Use Drugs, Biologics, Medical Devices 12/31/86
47. Measurement of Relative Humidity in the ETO Process Drugs and Medical Devices 4/30/87
48. Microbiological Contamination of Equipment Gaskets with Product Contact All Programs 12/31/86
49. Stock Rotomat Foods 5/30/87
50. Capacitor Medical Devices/Radiological Health 10/23/87
51. Electronic Relays Medical Devices/Radiological Health 11/10/87
52. Voice Recognition Systems GLP and Devices 11/10/87
Medical Device GMP Reference Information--(link to page maintained by CDRH)
QS Regulation/Design Controls
----------------------------------------------------------------------------------------------------------------
Dated: March 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-2941 Filed 3-27-06; 8:45 am]
BILLING CODE 4160-01-S