Reports and guidance documents; availability, etc.: Guidance documents; annual list,
[Federal Register: January 5, 2005 (Volume 70, Number 3)]
[Notices]
[Page 824-913]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja05-85]
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.
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 It also provides information on guidance documents that have been added or withdrawn in the past year.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. We have provided information in the
tables in the SUPPLEMENTARY INFORMATION section of this document on where to obtain a single copy of any of the guidance documents listed.
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:
-
Background
FDA's GGPs were published in the Federal Register of September 19, 2000 (65 FR 56468), and became effective October 19, 2000. GGPs 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 (Sec. 10.115 (21 CFR 10.115)). 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 October 24, 2001 (66 FR 53836).
The following comprehensive list identifies all guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn since the last publication of this comprehensive list are also identified. These withdrawn guidances include some final and draft guidances that had been withdrawn prior to the date of publication of this list, and some that are being withdrawn as of this date. 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. Please note that although we have stated that the ``Guidance for Industry on Qualified Health Claims in Labeling of Conventional Foods and Dietary Supplements'' (December 2002) has been ``replaced'' by subsequent guidance, the agency has not abandoned the position in the 2002 guidance regarding reasonable consumer standard.
We have organized the documents by the issuing center or office within FDA, and have identified the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing center or office maintains its own database, there are slight variations in the way in which they provide information in the tables in this document.
The following most frequently used Internet sites for agency guidances are provided for future reference:
Center for Biologics Evaluation and Research (CBER): http://www.fda.gov/cber/guidelines.htm Center for Drug Evaluation and Research (CDER): http://www.fda.gov/cder/guidance/index.htm
Center for Devices and Radiological Health (CDRH): http://
http://www.fda.gov/cdrh/guidance.html
Center for Food Safety and Applied Nutrition (CFSAN):
http://www.cfsan.fda.gov/dms/guidance.html Center for Veterinary Medicine (CVM): http://www.fda.gov/cvm/guidance/published.htm
Office of Regulatory Affairs (ORA) and Office of the
[[Page 825]]
/http://www.fda.gov/opacom/morechoices/industry/guidance.htm
Guidance Documents Issued by CBER
How to Obtain a Copy Intended of the Document Name of Document
Date of User or ----------------------- Issuance Regulatory Mailing Internet Activity Address Address
Guidelines for
June FDA
Office of http:// Immunization of Source 1980 regulated Communica www.fda.g
Plasma (Human) Donors
industry tion, ov/cber/ With Blood Substances
Training, guideline and
s.htm Manufactu rers Assistanc e (HFM- 40), Center for Biologics Evaluatio n and Research, Food and Drug Administr ation, 1401 Rockville Pike, Rockville , MD 20852-144 8, 1-800- 835-4709 or 301- 827-1800
Collection of Human
January Ditto (Do) Do.
http:// Leukocytes for Further 28,
www.fda.g
Manufacturing (Source 1981
ov/cber/ Leukocytes)
memo.htm
Interferon Test
July 28, Do.
Do.
http:// Procedures: Draft Points 1983
www.fda.g
to Consider (PTC) in the
ov/cber/ Production and Testing of
guideline Interferon Intended for
s.htm Investigational Use in Humans
Deferral of Blood Donors February Do.
Do.
http:// Who Have Received the 28,
www.fda.g
Drug Accutane
1984
ov/cber/ (isotretinoin/Roche; 13-
memo.htm cis-retinoic acid)
Equivalent Methods for December Do.
Do.
Do. Compatibility Testing 14, 1984
Plasma Derived From
December Do.
Do.
Do. Therapeutic Plasma
14, Exchange
1984
Draft PTC in the
April Do.
Do.
http:// Production and Testing of 10,
www.fda.g
New Drugs and Biologicals 1985
ov/cber/ Produced by Recombinant
guideline DNA Technology
s.htm
Reduction of the Maximum June 2, Do.
Do.
http:// Platelet Storage Period 1986
www.fda.g
to 5 Days in an Approved
ov/cber/ Container
memo.htm
To In Vitro Diagnostic December Do.
Do.
Do. Reagent Manufacturers: 6, 1986 Guidance on the Labeling of Human Blood Derived In Vitro Diagnostic Devices in Regard to Labeling for HTLV-III/LAV Antibody Testing
Guideline on General
May 1987 Do.
Do.
http:// Principles of Process
www.fda.g
Validation
ov/cber/ guideline s/htm
Deferral of Donors Who November Do.
Do.
http:// Have Received Human
25,
www.fda.g
Pituitary-Derived Growth 1987
ov/cber/ Hormone
memo.htm
Guideline on Validation of December Do.
Do.
http:// the Limulus Amebocyte 1987
www.fda.g
Lysate Test as an End-
ov/cber/ Product Endotoxin Test
guideline for Human and Animal
s.htm Parenteral Drugs, Biological Products, and Medical Devices
Recommendations for the December Do.
Do.
http:// Management of Donors and 2, 1987
www.fda.g
Units That Are Initially
ov/cber/ Reactive for Hepatitis B
memo.htm Surface Antigen (HbsAg)
Extension of Dating Period December Do.
Do.
Do. for Storage of Red Blood 4, 1987 Cells, Frozen
To Licensed In Vitro
December Do.
Do.
Do. Diagnostic Manufacturers: 23, Handling of Human Blood 1987 Source Materials
Recommendations for
April 6, Do.
Do.
Do. Implementation of
1988 Computerization in Blood Establishments
Control of Unsuitable April 6, Do.
Do.
Do. Blood and Blood
1988 Components
[[Page 826]]
Discontinuance of
July 7, Do.
Do.
Do. Prelicensing Inspection 1988 for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies Vaccines
Physician Substitutes August Do.
Do.
Do. 15, 1988
To Licensed Manufacturers August Do.
Do.
Do. of Blood Grouping
26, Reagents: Criteria for 1988 Exemption of Lot Release
Revised Guideline for the October Do.
Do.
Do. Collection of Platelets, 7, 1988 Pheresis
To Manufacturers of HTLV-I October Do.
Do.
Do. Antibody Test Kits:
18, Antibody to Human T-Cell 1988 Lymphotropic Virus, Type I (HTLV-I) Release Panel I
HTLV-1 Antibody Testing November Do.
Do.
Do. 29, 1988
Use of Recombigen HIV-1 LA February Do.
Do.
Do. Test
1, 1989
Guidance for Autologous March Do.
Do.
Do. Blood and Blood
15, Components
1989
Use of Recombigen HIV-1 August Do.
Do.
Do. Latex Agglutination (LA) 1, 1989 Test
Draft PTC in the
August Do.
Do.
http:// Manufacture and Clinical 8, 1989
www.fda.g
Evaluation of In Vitro
ov/cber/ Tests to Detect
guideline Antibodies to the Human
s.htm Immunodeficiency Virus, Type 1
PTC in the Collection, August Do.
Do.
Do. Processing, and Testing 22, of Ex Vivo Activated
1989 Mononuclear Leukocytes for Administration to Humans
Requirements for
Septembe Do.
Do.
http:// Computerization of Blood r 8,
www.fda.g
Establishments
1989
ov/cber/ memo.htm
Abbott Laboratories' HIVAG- October Do.
Do.
Do. 1 Test for HIV-1
4, 1989 Antigen(s) Not Recommended for Use as a Donor Screen
Guideline for Collection October Do.
Do.
Do. of Blood or Blood
26, Products From Donors With 1989 Positive Tests for Infectious Disease Markers (``High Risk'' Donors)
Guideline for the
January Do.
Do.
http:// Determination of Residual 1990
www.fda.g
Moisture in Dried
ov/cber/ Biological Products
guideline s.htm
Autologous Blood
February Do.
Do.
http:// Collection and Processing 12,
www.fda.g
Procedures
1990
ov/cber/ memo.htm
Use of Genetic Systems HIV- June 21, Do.
Do.
Do. 2 EIA
1990
FDA Request for
March Do.
Do.
Do. Information on Blood
15, Storage Patterns and Red 1991 Cell Contamination by Yersinia Enterocolitica
Revision to October 26, April Do.
Do.
Do. 1989, Guideline for
17, Collection of Blood or 1991 Blood Products From Donors With Positive Tests for Infectious Disease Markers (``High Risk'' Donors)
Deficiencies Relating to March Do.
Do.
Do. the Manufacture of Blood 20, and Blood Components
1991
Responsibilities of Blood March Do.
Do.
Do. Establishments Related to 20, Errors and Accidents in 1991 the Manufacture of Blood and Blood Components
FDA Recommendations
Septembe Do.
Do.
Do. Concerning Testing for r 10, Antibody to Hepatitis B 1991 Core Antigen (Anti-HBc)
[[Page 827]]
Disposition of Blood
Septembe Do.
Do.
Do. Products Intended for r 11, Autologous Use That Test 1991 Repeatedly Reactive for Anti-HCV
Clarification of FDA
December Do.
Do.
Do. Recommendations for Donor 12, Deferral and Product
1991 Distribution Based on the Results of Syphilis Testing
Supplement to the PTC in April 6, Do.
Do.
http:// the Production and
1992
www.fda.g
Testing of New Drugs and
ov/cber/ Biologics Produced by
guideline Recombinant DNA
s.htm Technology: Nucleic Acid Characterization and Genetic Stability
Revised Recommendations April Do.
Do.
http:// for the Prevention of 23,
www.fda.g
Human Immunodeficiency 1992
ov/cber/ Virus (HIV) Transmission
memo.htm by Blood and Blood Products
Use of Fluorognost HIV-1 April Do.
Do.
Do. Immunofluorescent Assay 23, (IFA)
1992
Revised Recommendations April Do.
Do.
Do. for Testing Whole Blood, 23, Blood Components, Source 1992 Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti- HCV)
Exemptions to Permit
April Do.
Do.
Do. Persons With a History of 23, Viral Hepatitis Before 1992 the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures, 21 CFR 640.120
Changes in Equipment for July 21, Do.
Do.
Do. Processing Blood Donor 1992 Samples
Nomenclature for
Septembe Do.
Do.
Do. Monoclonal Blood Grouping r 28, Reagents
1992
Volume Limits for
November Do.
Do.
Do. Automated Collection of 4, 1992 Source Plasma
FDA's Policy Statement November Do.
Do.
http:// Concerning Cooperative 25,
www.fda.g
Manufacturing
1992
ov/cber/ Arrangements for Licensed
guideline Biologics
s.htm
Revision of October 7, December Do.
Do.
http:// 1988, Memo Concerning Red 16,
www.fda.g
Blood Cell Immunization 1992
ov/cber/ Programs
memo.htm
Draft PTC in the
July 12, Do.
Do.
http:// Characterization of Cell 1993
www.fda.g
Lines Used to Produce
ov/cber/ Biologicals
guideline s.htm
Guidance on Alternatives July 20, Do.
Do.
Do. to Lot Release for
1993 Licensed Biological Products
Recommendations Regarding July 22, Do.
Do.
http:// License Amendments and 1993
www.fda.g
Procedures for Gamma
ov/cber/ Irradiation of Blood
memo.htm Products
Deferral of Blood and July 28, Do.
Do.
Do. Plasma Donors Based on 1993 Medications
Revised Recommendations August Do.
Do.
Do. for Testing Whole Blood, 5, 1993 Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti- HCV)
Clarification of the Use August Do.
Do.
Do. of Unlicensed Anti-HCV 19, Supplemental Test Results 1993 in Regard to Donor Notification
Draft Guideline for the Septembe Do.
Do.
http:// Validation of Blood
r 28,
www.fda.g
Establishment Computer 1993
ov/cber/ Systems
guideline s.htm
Guidance Regarding Post December Do.
Do.
http:// Donation Information
10,
www.fda.g
Reports
1993
ov/cber/ memo.htm
[[Page 828]]
Donor Suitability Related December Do.
Do.
Do. to Laboratory Testing for 22, Viral Hepatitis and a 1993 History of Viral Hepatitis
Recommendations for the January Do.
Do.
Do. Invalidation of Test
3, 1994 Results When Using Licensed Viral Marker Assays to Screen Donors
Recommendations for
July 26, Do.
Do.
Do. Deferral of Donors for 1994 Malaria Risk
Office of Establishment August Do.
Do.
http:// Licensing and Product 1994
www.fda.g
Surveillance (OELPS),
ov/cber/ Advertising and
guideline Promotional Labeling
s.htm Staff, Procedural Guidance Document (Draft)
Guidance for Industry for November Do.
Do.
Do. the Submission of
1994 Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances
Recommendations to Users December Do.
Do.
http:// of Medical Devices That 20,
www.fda.g
Test for Infectious
1994
ov/cber/ Disease Markers by Enzyme
memo.htm Immunoassay (EIA) Test Systems
Timeframe for Licensing February Do.
Do.
Do. Irradiated Blood Products 3, 1995
Revision of August 27, March Do.
Do.
Do. 1982, FDA Memo:
10, Requirements for
1995 Infrequent Plasmapheresis Donors
To All Licensed
March Do.
Do.
Do. Establishments Performing 14, Red Blood Cell
1995 Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors
Recommendations for the June 8, Do.
Do.
Do. Deferral of Current and 1995 Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes, and Source Plasma
Guideline for Quality July 11, Do.
Do.
http:// Assurance in Blood
1995
www.fda.g
Establishments
ov/cber/ guideline s.htm
FDA Guidance Document July 11, Do.
Do.
Do. Concerning Use of Pilot 1995 Manufacturing Facilities for the Development and Manufacture of Biological Products
Recommendations for
August Do.
Do.
http:// Labeling and Use of Units 8, 1995
www.fda.g
of Whole Blood, Blood
ov/cber/ Components, Source
memo.htm Plasma, Recovered Plasma, or Source Leukocytes Obtained From Donors With Elevated Levels of Alanine Aminotransferase (ALT)
Recommendations for Donor August Do.
Do.
Do. Screening With a Licensed 8, 1995 Test for HIV-1 Antigen
PTC in the Manufacture and 1995 Do.
Do.
http:// Testing of Therapeutic
www.fda.g
Products for Human Use
ov/cber/ Derived From Transgenic
guideline Animals
s.htm
Draft Reviewers' Guide: October FDA
Do.
Do. Informed Consent for
1, 1995 personnel Plasmapheresis/ Immunization
Draft Reviewers' Guide: October Do.
Do.
Do. Disease Associated
1, 1995 Antibody Collection Program
Draft Document Concerning December Do.
Do.
http:// the Regulation of
1995
www.fda.g
Placental/Umbilical Cord
ov/cber/ Blood Stem Cell Products
memo.htm Intended for Transplantation or Further Manufacturing Into Injectable Products
[[Page 829]]
Donor Deferral Due to Red December FDA
Do.
Do. Blood Cell Loss During 4, 1995 regulated Collection of Source
industry Plasma by Automated Plasmapheresis
Draft Document Concerning February Do.
Do.
Do. the Regulation of
1996 Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products
International Conference February Do.
Do.
http:// on Harmonisation (ICH) 23,
www.fda.g
Final Guideline on
1996
ov/cber/ Quality of
guideline Biotechnological
s.htm Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
ICH Final Guideline on the March 1, Do.
Do.
Do. Need for Long-Term Rodent 1996 Carcinogenicity Studies of Pharmaceuticals
Additional Recommendations March Do.
Do.
http:// for Donor Screening With 14,
www.fda.g
a Licensed Test for HIV-1 1996
ov/cber/ Antigen
memo.htm
FDA Guidance Concerning April Do.
Do.
http:// Demonstration of
1996
www.fda.g
Comparability of Human
ov/cber/ Biological Products,
guideline Including Therapeutic
s.htm Biotechnology-Derived Products
Additional Recommendations May 16, Do.
Do.
http:// for Testing Whole Blood, 1996
www.fda.g
Blood Components, Source
ov/cber/ Plasma, and Source
memo.htm Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti- HCV)
Guidance for Industry--The May 1996 Do.
Do.
http:// Content and Format for
www.fda.g
Pediatric Use Supplements
ov/cber/ guideline s.htm
Guidance on Applications May 1996 Do.
Do.
Do. for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair or Reconstruction
Recommendations and
May 29, Do.
Do.
http:// Licensure Requirements 1996
www.fda.g
for Leukocyte-Reduced
ov/cber/ Blood Products
memo.htm
ICH Final Guidelines on July 10, Do.
Do.
http:// Stablity Testing of
1996
www.fda.g
Biotechnological/
ov/cber/ Biological Products
guideline s.htm
Recommendations for the July 19, Do.
Do.
http:// Quarantine and
1996
www.fda.g
Disposition of Units From
ov/cber/ Prior Collections From
memo.htm Donors With Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T- Lymphotropic Virus Type I (HTLV-I)
Guidance for Industry for August Do.
Do.
http:// the Submission of
1996
www.fda.g
Chemistry, Manufacturing,
ov/cber/ and Controls Information
guideline for a Therapeutic
s.htm Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use
Interim Recommendations December Do.
Do.
http:// for Deferral of Donors at 11,
www.fda.g
Increased Risk for HIV-1 1996
ov/cber/ Group O Infection
memo.htm
PTC on Plasmid DNA
December Do.
Do.
http:// Vaccines for Preventive 1996
www.fda.g
Infectious Disease
ov/cber/ Indications
guideline s.htm
Guidance for the
January Do.
Do.
Do. Submission of Chemistry, 1997 Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products
Reviewer Guidance for a January FDA
Do.
Do. Premarket Notification 13, personnel Submission for Blood
1997 Establishment Computer Software
[[Page 830]]
PTC in the Manufacture and February FDA
Do.
Do. Testing of Monoclonal 28, regulated Antibody Products for 1997 industry Human Use
Proposed Approach to
February Do.
Do.
Do. Regulation of Cellular 28, and Tissue-Based Products 1997
Guidance for Industry for April Do.
Do.
Do. the Evaluation of
1997 Combination Vaccines for Preventable Diseases: Production, Testing, and Clinical Studies
ICH Guidelines for the May 16, Do.
Do.
Do. Photostability Testing of 1997 New Drug Substances and Products
Guidance for Industry: July Do.
Do.
Do. Changes to an Approved 1997 Application: Biological Products
Guidance for Industry: July Do.
Do.
Do. Changes to an Approved 1997 Application for Specified Biotechnology and Specified Synthetic Biological Products
Guidance for Industry: July Do.
Do.
Do. Screening and Testing of 1997 Donors of Human Tissue Intended for Transplantation
Guidance for Industry: August Do.
Do.
Do. Donor Screening for
1997 Antibodies to HTLV-II
Guidance for Industry: August Do.
Do.
Do. Postmarketing Adverse 1997 Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report
Guidance for Industry: The Septembe Do.
Do.
Do. Sourcing and Processing r 1997 of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use
Guidance for FDA and
November FDA
Do.
Do. Industry: Direct Final 21, personnel Rule Procedures
1997 and regulated industry
Draft Guidance for
December FDA
Do.
Do. Industry: Promoting
1997 regulated Medical Products in a
industry Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)
Guidance for Industry: November Do.
Do.
Do. Industry-Supported
1997 Scientific and Educational Activities
Guidance for Industry: January Do.
Do.
Do. Year 2000 Date Change for 1998 Computer Systems and Software Applications Used in the Manufacture of Blood Products
Draft Guidance for
January Do.
Do.
Do. Industry: Container and 28, Closure Integrity Testing 1998 In Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
Draft Guidance for
March Do.
Do.
Do. Industry: Manufacturing, 1998 Processing, or Holding Active Pharmaceutical Ingredients
Guidance for Industry: March Do.
Do.
Do. Guidance for Human
1998 Somatic Cell Therapy and Gene Therapy
Draft Guidance for
May 1998 Do.
Do.
Do. Industry: Instructions for Submitting Electronic Lot Release Protocols to CBER
[[Page 831]]
Guidance for Industry: May 14, Do.
Do.
Do. Classifying Resubmissions 1998 in Response to Action Letters
Guidance for Industry: May 1998 Do.
Do.
Do. Pharmacokinetics in Patients With Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing and Labeling
Guidance for Industry: May 15, Do.
Do.
Do. Standards for the Prompt 1998 Review of Efficacy Supplements, Including Priority Efficacy Supplements
Guidance for Industry: May 1998 Do.
Do.
Do. Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
Draft Guidance for
June Do.
Do.
Do. Industry: Stability
1998 Testing of Drug Substances and Drug Products
Guidance for Industry: June Do.
Do.
Do. Errors and Accidents
1998 Regarding Saline Dilution of Samples Used for Viral Marker Testing
ICH Guidance on Ethnic June 10, Do.
Do.
Do. Factors in the
1998 Acceptability of Foreign Clinical Data
Draft Guidance for
June 12, Do.
Do.
Do. Industry: Exports and 1998 Imports Under the FDA Export Reform and Enhancement Act of 1996
Guidance for Industry: July Do.
Do.
Do. Implementation of Section 1998 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of Certain Labeling Requirements
Guidance for Industry: July Do.
Do.
Do. Environmental Assessment 1998 of Human Drug and Biologics Applications
Draft Guidance for
Septembe Do.
Do.
Do. Industry: Submitting
r 1998 Debarment Certification Statements
Guidance for Industry: How Septembe Do.
Do.
Do. to Complete the Vaccine r 1998 Adverse Event Reporting System Form (VAERS-1)
Guidance for Industry: July Do.
Do.
Do. Fast Track Drug
2004 Development Programs-- Designation, Development, and Application Review
ICH Guidance on
Septembe Do.
Do.
Do. Statistical Principles r 16, for Clinical Trials
1998
ICH Guidance on Quality of Septembe Do.
Do.
Do. Biotechnological/
r 21, Biological Products:
1998 Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products
ICH Guidance on Viral Septembe Do.
Do.
Do. Safety Evaluation of
r 24, Biotechnology Products 1998 Derived From Cell Lines of Human or Animal Origin
Draft Guidance for
November Do.
Do.
Do. Industry: General
1998 Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products
Guidance for Industry: FDA December Do.
Do.
Do. Approval of New Cancer 1998 Treatment Uses for Marketed Drug and Biological Products
Draft Guidance for
January Do.
Do.
Do. Industry: Product Name 1999 Placement, Size, and Prominence in Advertising and Promotional Labeling
[[Page 832]]
Guidance for Industry: January Do.
Do.
Do. Content and Format of 1999 Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product
Guidance on Amended
January Do.
Do.
Do. Procedures for Advisory 26, Panel Meetings
1999
Draft Guidance for
October Do.
Do.
http:// Industry; Providing
2003
www.fda.g
Regulatory Submissions in
ov/cber/ Electronic Format--
esub/ General Considerations
esubguid. htm
Guidance for Industry: February Do.
Do.
http:// Population
1999
www.fda.g
Pharmacokinetics
ov/cber/ guideline s.htm
Guidance for Industry: February Do.
Do.
Do. Clinical Development
1999 Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
Guidance for Industry: For February Do.
Do.
Do. the Submission of
1999 Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma, or Serum-Derived Products
Draft Guidance for
March Do.
Do.
Do. Industry: Accelerated 1999 Approval Products-- Submission of Promotional Materials
Guidance for Industry: March Do.
Do.
Do. Content and Format of 1999 Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
Guidance for Industry: April Do.
Do.
Do. Public Health Issues
1999 Posed by the Use of Nonhuman Primate Xenografts in Humans
Guidance for Industry on April Do.
Do.
Do. the Content and Format of 1999 Chemistry, Manufacturing, and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
Guidance for Industry for May 1999 Do.
Do.
Do. 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''
Draft Guidance for
May 1999 Do.
Do.
Do. Industry for Platelet Testing and Evaluation of Platelet Substitute Products
Guidance for Industry: May 1999 Do.
Do.
Do. Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
Draft Reviewer Guidance: June FDA
Do.
Do. Evaluation of Human
1999 personnel Pregnancy Outcome Data
Draft Guidance for
June FDA
Do.
Do. Industry: Current Good 1999 regulated Manufacturing Practice
industry 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)
[[Page 833]]
ICH Guidance on the
June 25, Do.
Do.
Do. Duration of Chronic
1999 Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)
Draft Guidance for
July Do.
Do.
Do. Industry: Clinical
1999 Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)
Draft Guidance for
July Do.
Do.
Do. Industry: Interpreting 1999 Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
Draft Guidance for
August Do.
Do.
Do. Industry: Cooperative 1999 Manufacturing Arrangements for Licensed Biologics
Guidance for Industry: August Do.
Do.
Do. Consumer-Directed
1999 Broadcast Advertisements
Guidance for Industry: August Do.
Do.
Do. Possible Dioxin/PCB
1999 Contamination of Drug and Biological Products
Guidance for Industry: August Do.
Do.
Do. Submission of Abbreviated 1999 Reports and Synopses in Support of Marketing Applications
ICH Guidance on
August Do.
Do.
Do. Specifications: Test
18, Procedures and Acceptance 1999 Criteria for Biotechnological/ Biological Products
Guidance for Industry: Septembe Do.
Do.
Do. Qualifying for Pediatric r 1999 Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry: November Do.
Do.
Do. Providing Regulatory
1999 Submissions to CBER in Electronic Format-- Biologics Marketing Applications (Biologics License Application (BLA), Product License Application (PLA)/ Establishment License Application (ELA), and New Drug Application (NDA)); revised
Guidance for Industry: In November Do.
Do.
Do. Vivo Drug Metabolism/Drug 1999 Interaction Studies-- Study Design, Data Analysis, and Recommendations for Dosing and Labeling
ICH of Technical
November Do.
Do.
Do. Requirements for
8, 1999 Registration of Pharmaceuticals for Human Use; M4: Common Technical Document
Guidance for Industry: In December Do.
Do.
Do. the Manufacture and
1999 Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
Guidance for Reviewers: November FDA
Do.
Do. Potency Limits for
2000 personnel Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
Guidance for Industry: February FDA
Do.
Do. Formal Meetings With
2000 regulated Sponsors and Applicants
industry for PDUFA Products
Guidance for Industry: February Do.
Do.
Do. Formal Dispute
2000 Resolution: Appeals Above the Division Level
Guidance for Industry: February Do.
Do.
Do. Gamma Irradiation of
2000 Blood and Blood Components: A Pilot Program for Licensing
[[Page 834]]
Draft Guidance for
May 2000 Do.
Do.
Do. Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics
Guidance for Industry: June Do.
Do.
Do. Recognition and Use of a 2000 Standard for the Uniform Labeling of Blood and Blood Components
Draft Guidance for
June Do.
Do.
Do. Industry: Recommendations 2000 for Donor Questioning Regarding Possible Exposure to Malaria
Draft Guidance for
June Do.
Do.
Do. Industry: Pediatric
2000 Oncology Studies in Response to a Written Request
Guidance for Industry: June Do.
Do.
Do. Availability of Licensed 2000 Donor Screening Tests Labeled for Use With Cadaveric Blood Specimens
Draft Guidance for
June Do.
Do.
Do. Industry: Chronic
2000 Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment
Draft Guidance for
August Do.
Do.
Do. Industry: Analytical
2000 Procedures and Methods Validation--Chemistry, Manufacturing, and Controls Documentation
Draft Guidance for
August Do.
Do.
Do. Industry: Considerations 2000 for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications
Guidance for Industry: Q & October Do.
Do.
Do. A Content and Format of 2000 INDs for Phase 1 Studies of Drugs, Including Well- Characterized, Therapeutic, Biotechnology-Derived Products
Guidance for Industry: October Do.
Do.
Do. Supplemental Guidance on 2000 Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Followup of Patients in Clinical Trials Using Retroviral Vectors
Guidance for Industry: October Do.
Do.
Do. Submitting and Reviewing 2000 Complete Responses to Clinical Holds
Guidance for Industry: November Do.
Do.
Do. Testing Limits in
2000 Stability Protocols for Standardized Grass Pollen Extracts
Guidance for Industry: Use November Do.
Do.
Do. of Sterile Connecting 2000 Devices in Blood Bank Practices
Draft Guidance for
November Do.
Do.
Do. Industry: Recommendations 2000 for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))
ICH Guidance for Industry: December Do.
Do.
Do. E11 Clinical
2000 Investigation of Medicinal Products in the Pediatric Population
Guidance for Industry: December Do.
Do.
Do. Submitting Separate
2000 Marketing Applications and Clinical Data for Purposes of Assessing User Fees
ICH Guidance on Q6A
December Do.
Do.
Do. Specifications: Test
29, Procedures and Acceptance 2000 Criteria for New Drug Substances and New Drug Products: Chemical Substances
PHS Guideline on
January Do.
Do.
Do. Infectious Disease Issues 19, in Xenotransplantation 2001
[[Page 835]]
Draft Guidance for
January Do.
Do.
Do. Industry: Pre-Storage 2001 Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion
Guidance for Industry: January Do.
Do.
Do. Recommendations for
2001 Collecting Red Blood Cells by Automated Apheresis Methods
Draft Guidance for
January Do.
Do.
Do. Industry: Providing
2001 Regulatory Submissions in Electronic Format-- Prescription Drug Advertising and Promotional Labeling
Guidance for Industry: February Do.
Do.
Do. Recommendations for
2001 Collecting Red Blood Cells by Automated Apheresis Methods-- Technical Correction
Draft Guidance for
February Do.
Do.
Do. Industry: Disclosing
2001 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
Draft Guidance for
March Do.
Do.
Do. Industry: Postmarketing 2001 Safety Reporting for Human Drug and Biological Products Including Vaccines
Guidance for Industry: March Do.
Do.
Do. Acceptance of Foreign 2001 Clinical Studies
Guidance for Industry: March Do.
Do.
Do. Financial Disclosure by 2001 Clinical Investigators
Guidance for Industry: March Do.
Do.
Do. Monoclonal Antibodies 2001 Used as Reagents in Drug Manufacturing
Draft Guidance for
April Do.
Do.
Do. Industry: Reports on the 2001 Status of Postmarketing Studies--Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
Draft Guidance for
May 2001 Do.
Do.
Do. Industry: Providing Regulatory Submissions in Electronic Format-- Postmarketing Expedited Safety Reports
Guidance for Industry: E10 May 2001 Do.
Do.
Do. Choice of Control Group and Related Issues in Clinical Trials
Draft Guidance for
May 2001 Do.
Do.
Do. Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Information
Draft Guidance for
July Do.
Do.
Do. Industry: Clinical
2001 Studies Section of Labeling for Prescription Drugs and Biologics-- Content and Format
Guidance for Industry: July Do.
Do.
Do. CBER Pilot Licensing
2001 Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside Supplier
Guidance for Industry: July Do.
Do.
Do. Revised Recommendations 2001 Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
ICH Guidance for Industry: July Do.
Do.
Do. S7A Safety Pharmacology 2001 Studies for Human Pharmaceuticals
[[Page 836]]
Guidance for FDA
July Do.
Do.
Do. Reviewers: Premarket
2001 Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
Guidance for FDA
July Do.
Do.
Do. Reviewers: Premarket
2001 Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
Guidance for FDA
July Do.
Do.
Do. Reviewers: Premarket
2001 Notification Submissions for Blood and Plasma Warmers
Guidance for Industry: July Do.
Do.
Do. Changes to an Approved 2001 Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
Draft Guidance for FDA August Do.
Do.
Do. Reviewers: Premarket
2001 Notification Submissions for Automated Testing Instruments Used in Blood Establishments
Draft Guidance for
August Do.
Do.
Do. Industry: Biological
2001 Product Deviation Reporting for Licensed Manufacturers of Biological Products Other Than Blood and Blood Components
Draft Guidance for
August Do.
Do.
Do. Industry: Biological
2001 Product Deviation Reporting for Blood and Plasma Establishments
Guidance for Industry: August Do.
Do.
Do. Variances for Blood
2001 Collection From Individuals With Hereditary Hemochromatosis
Draft Guidance for
August Do.
Do.
Do. Industry: Submitting Type 2001 V Drug Master Files to the CBER
Draft Guidance for
August Do.
Do.
Do. Industry: Premarket
2001 Notifications (510(k)s) for In Vitro HIV Drug Resistance Genotype Assays: Special Controls
Draft Guidance for
August Do.
Do.
Do. Industry: Submitting
2001 Marketing Applications According to the ICH-CTD Format--General Considerations
ICH Guidance: Q7A Good August Do.
Do.
Do. Manufacturing Practice 2001 Guide for Active Pharmaceutical Ingredients
ICH Guidance on M4 Common August Do.
Do.
Do. Technical Document
2001
Guidance for Industry: October Do.
Do.
Do. Cancer Drug and
2001 Biological Products-- Clinical Data in Marketing Applications
Guidance for Industry: October Do.
Do.
Do. Content and Format of 2001 Geriatric Labeling
Guidance for Industry: October Do.
Do.
Do. Recommendations for
2001 Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax
Draft Guidance for
November Do.
Do.
Do. Clinical Trial Sponsors 2001 on the Establishment and Operation of Clinical Trial Data Monitoring Committees
Guidance for Industry: November Do.
Do.
Do. Information Request and 2001 Discipline Review Letters Under the Prescription Drug User Fee Act
[[Page 837]]
Guidance for Industry: January Do.
Do.
Do. Revised Preventive
2002 Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
Guidance for Industry: January Do.
Do.
Do. General Principles of 2002 Software Validation; Final Guidance for Industry and FDA Staff
Draft Guidance for
February Do.
Do.
Do. Industry: Precautionary 2002 Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their Intimate Contacts
Guidance for Industry: March Do.
Do.
Do. Validation of Procedures 2002 for Processing of Human Tissues Intended for Transplantation
Guidance for Industry; March Do.
Do.
http:// Information Program on 2002
www.fda.g
Clinical Trials for
ov/cber/ Serious or Life-
gdlns/ Threatening Diseases and
clintrial Conditions
031802.pd f
Guidance for Industry: March Do.
Do.
http:// Providing Regulatory
2002
www.fda.g
Submissions to CBER in
ov/cber/ Electronic Format--
guideline Investigational New Drug
s.htm Applications (INDs)
Guidance for Industry: April Do.
Do.
Do. E2BM Data Elements for 2002 Transmission of Individual Case Safety Reports
Draft Guidance for
April Do.
Do.
Do. Industry: A Modified Lot- 2002 Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations
Guidance for Industry: May 1999 Do.
Do.
Do. Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation
Guidance for Industry: May 2002 Do.
Do.
Do. Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers
Draft Guidelines for
May 2002 Do.
Do.
Do. Ensuring the Quality of Information Disseminated to the Public (HHS Guideline)
Guidance for Industry: May 2002 Do.
Do.
Do. Special Protocol Assessment
Draft Guidance for
June Do.
Do.
Do. Industry: Preventive
2002 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)
Draft Guidance for
August Do.
Do.
Do. Industry: 21 CFR Part 11; 2002 Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
Guidance for Industry: August Do.
Do.
Do. Establishing Pregnancy 2002 Exposure Registries
Draft Guidance for
Septembe Do.
Do.
Do. Industry: Drugs,
r 2002 Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals
Draft Guidance for
Septembe Do.
Do.
Do. Industry: Nonclinical r 2002 Studies for Development of Pharmaceutical Excipients
[[Page 838]]
The Least Burdensome
October Do.
Do.
Do. Provisions of the FDA 2002 Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
Guidance for Industry and December Do.
Do.
http:// FDA Staff; Class II
18,
www.fda.g
Special Controls Guidance 2003
ov/cber/ Document: Human Dura
gdlns/ Mater
humdurama t.pdf
Guidance for Industry: December Do.
Do.
http:// Recommendations for
2002
www.fda.g
Deferral of Donors and
ov/cber/ Quarantine and Retrieval
guideline of Blood and Blood
s.htm Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients
Draft Guidance for
December Do.
Do.
Do. Industry and Reviewers on 2002 Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers
ICH Guidance for Industry; January Do.
Do.
Do. Q1D Bracketing and
2003 Matrixing Designs for Stability Testing of New Drug Substances and Products
Draft Guidance for
January Do.
Do.
Do. Industry: Collection of 2003 Race and Ethnicity Data in Clinical Trials
Draft Guidance for
January Do.
Do.
Do. Industry: Drug Product: 2003 Chemistry, Manufacturing, and Controls Information
ICH Guidance for Industry: February Do.
Do.
Do. M4 CTD--Safety: Questions 2003 and Answers
Guidance for Industry and February Do.
Do.
Do. FDA Staff: Quality System 2003 Information for Certain Premarket Application Reviews
ICH Guidance for Industry: February Do.
Do.
Do. Q3A Impurities in New 2003 Drug Substances
Draft Guidance for
February Do.
Do.
Do. Industry; Comparability 2003 Protocols--Chemistry, Manufacturing, and Controls Information
Assessing User Fees: PMA February Do.
Do.
http:// Supplement Definitions, 25,
www.fda.g
Modular PMA Fees, BLA and 2003
ov/cber/ Efficacy Supplement
dap/ Definitions, Bundling
devpubs.h Multiple Devices in a
tm Single Application, and Fees for Combination Products; Guidance for Industry and FDA
Guidance for Industry and March Do.
Do.
http:// FDA: FY 2003 MDUFMA Small 2003
www.fda.g
Business Qualification
ov/cber/ Worksheet and
guideline Certification
s.htm
ICH Guidance for Industry: April Do.
Do.
Do. M2 eCTD: Electronic
2003 Common Technical Document Specification
Guidance for Industry: April Do.
Do.
Do. Source Animal, Product, 2003 Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
Guidance for Industry: April Do.
Do.
Do. Recommendations for the 2003 Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
Guidance for Industry, FDA October Do.
Do.
http:// Staff, and Third Parties; 4, 2004
www.fda.g
Implementation of the
ov/cber/ Inspection by Accredited
dap/ Persons Program Under the
devpubs.h Medical Device User Fee
tm and Modernization Act of 2002; Accreditation Criteria
[[Page 839]]
Guidance for Industry: April Do.
Do.
http:// Exposure-Response
2003
www.fda.g
Relationships--Study
ov/cber/ Design, Data Analysis,
guideline and Regulatory
s.htm Applications
Guidance for Industry: May 2003 Do.
Do.
Do. Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
Guidance for Industry: May 2003 Do.
Do.
Do. Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
Draft Guidance for
June Do.
Do.
Do. Industry and FDA Staff: 2003 Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002--Identification of Manufacturer of Medical Devices
Guidance for FDA Staff: June Do.
Do.
Do. The Leveraging Handbook, 2003 An Agency Resource for Effective Collaborations
Draft Guidance for
June Do.
Do.
Do. Industry: Providing
2003 Regulatory Submissions in Electronic Format-- Postmarketing Periodic Adverse Drug Experience Reports
Draft Guidance for
June Do.
Do.
Do. Industry: Revised
2003 Recommendations for Donor and Product Management Based on Screening Tests for Syphilis
Guidance for Industry and July Do.
Do.
Do. FDA Staff: Medical Device 2003 User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
Guidance for Industry: July Do.
Do.
Do. Streamlining the Donor 2003 Interview Process: Recommendations for Self- Administered Questionnaires
Draft Guidance for
July Do.
Do.
Do. Industry and FDA Staff: 2003 Premarket Assessment of Pediatric Medical Devices
Draft Guidance for Review July Do.
Do.
Do. Staff and Industry: Good 2003 Review Management Principles for PDUFA Products
Compliance Program
Dates Do.
Do.
http:// Guidance Manual (drugs vary--I
www.fda.g
and biologics)
ndividu
ov/cber/ al
cpg/ issue
cpg.htm dates
ICH Guidance for Industry: November Do.
Do.
http:// Q3C--Tables and List
2003
www.fda.g
ov/cber/ guideline s.htm
ICH Guidance for Industry: November Do.
Do.
Do. Q3B(R) Impurities in New 2003 Drug Products
ICH Guidance for Industry: November Do.
Do.
Do. Q1A(R2) Stability Testing 2003 of New Drug Substances and Products §§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§ WITHDRAWN GUIDANCES
Draft Guidance for
November Do.
N/A Industry: Application of 1999 Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma
Draft Document Concerning December Do.
Do. the Regulation of
1995 Placental/Umbilical Cord Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable Products
[[Page 840]]
Draft Document Concerning February Do.
Do. the Regulation of
1996 Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing into Injectable Products
Draft Advertising and August Do.
Do. Promotional Labeling
1994 Staff Procedural Guidance
Draft Guidance for
August Do.
Do. Industry: 21 CFR Part 11; 2001 Electronic Records; Electronic Signatures; Validation
Draft Guidance for
August Do.
Do. Industry: 21 CFR Part 11; 2001 Electronic Records; Electronic Signatures; Glossary of Terms
Draft Guidance for
February Do.
Do. Industry: 21 CFR Part 11; 2002 Electronic Records; Electronic Signatures; Time Stamps
Draft Guidance for
July Do.
Do. Industry: 21 CFR Part 11; 2002 Electronic Records; Electronic Signatures, Maintenance of Electronic Records
Guidance Documents Issued by CDER
How to Obtain a Copy Intended of the Document Name of Document
Date of User or ----------------------- Issuance Regulatory Mailing Internet Activity Address Address
Aerosol Steroid Product January Advertisin Division http:// Safety Information in 12, g
of Drug www.fda.g
Prescription Drug
1998
Informati ov/cder/ Advertising and
on (HFD- guidance/ Promotional Labeling
200), index.htm Office of Training and Communica tions, Center for Drug Evaluatio n and Research, Food and Drug Administr ation, 5600 Fishers Lane, Rockville , MD 20857, 301-827-4 573
Consumer-Directed
August Do.
Do.
Do. Broadcast Advertisements 9, 1999
Industry-Supported
December Do.
Do.
Do. Scientific and
3, 1997 Educational Activities
Accelerated Approval
March Advertisin Do.
Do. Products--Submission of 26, g draft Promotional Materials 1999
Brief Summary: Disclosing February Do.
Do.
Do. Risk Information in
10, Consumer-Directed Print 2004 Advertisements
``Help-Seeking'' and Other February Do.
Do.
Do. Disease Awareness
10, Communications by or on 2004 Behalf of Drug and Device Firms
Product Name Placement, March Do.
Do.
Do. Size, and Prominence in 12, Advertising and
1999 Promotional Labeling
Promoting Medical Products January Do.
Do.
Do. in a Changing Healthcare 5, 1998 Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)
Bioanalytical Method
May 23, Biopharmac Do.
Do. Validation
2001 eutics
[[Page 841]]
Bioavailability and
March Do.
Do.
Do. Bioequivalence Studies 19, for Orally Administered 2003 Drug Products--General Considerations
Cholestyramine Powder In July 15, Do.
Do.
Do. Vitro Bioequivalence
1993
Clozapine Tablets In Vivo November Do.
Do.
Do. Bioequivalence and In 15, Vitro Dissolution Testing 1996
Corticosteroids,
June 2, Do.
Do.
Do. Dermatologic (topical) In 1995 Vivo
Dissolution Testing of August Do.
Do.
Do. Immediate Release Solid 25, Oral Dosage Forms
1997
Extended Release Oral Septembe Do.
Do.
Do. Dosage Forms:
r 26, Development, Evaluation, 1997 and Application of In Vitro/In Vivo Correlations
Food-Effect
December Do.
Do.
Do. Bioavailability and Fed 2002 Bioequivalence Studies
Metaproterenol Sulfate and June 27, Do.
Do.
Do. Albuterol Metered Dose 1989 Inhalers In Vitro
Phenytoin/Phenytion Sodium March 4, Do.
Do.
Do. (capsules, tablets,
1994 suspension) In Vivo Bioequivalence and In Vitro Dissolution Testing
Statistical Approaches to February Do.
Do.
Do. Establishing
2, 2001 Bioequivalence
Waiver of In Vivo
August Do.
Do.
Do. Bioavailability and
31, Bioequivalence Studies 2000 for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Antifungal (topical)
February Biopharmac Do.
N/A 24, eutics 1990 draft
Antifungal (vaginal)
February Do.
Do.
Do. 24, 1990
Bioavailability and
April Do.
Do.
http:// Bioequivalence Studies 2003
www.fda.g
for Nasal Aerosols and
ov/cder/ Nasal Sprays for Local
guidance/ Action
index.htm
Clozapine Tablets: In Vivo December Do.
Do.
Do. Bioequivalence and In 2003 Vitro Dissolution Testing
Conjugated Estrogens, USP- March Do.
Do.
Do. LC-MS Method for Both 2000 Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence
BACPAC I: Intermediates in February Chemistry Do.
http:// Drug Substance Synthesis: 16,
www.fda.g
Bulk Actives Postapproval 2001
ov/cder/ Changes: Chemistry,
guidance/ Manufacturing, and
index.htm Controls Documentation
Changes to an Approved July 24, Do.
Do.
Do. Application for Specified 1997 Biotechnology and Specified Synthetic Biological Products
Changes to an Approved NDA April Do.
Do.
Do. or ANDA
2004
Changes to an Approved NDA January Do.
Do.
Do. or ANDA: Questions and 22, Answers
2001
Container Closure Systems May 1999 Do.
Do.
Do. for Packaging Human Drugs and Biologics
[[Page 842]]
Demonstration of
April Do.
Do.
Do. Comparability of Human 1996 Biological Products, Including Therapeutic Biotechnology-Derived Products
Development of New
May 1, Do.
Do.
Do. Stereoisomeric Drugs
1992
Drug Master Files
Septembe Do.
Do.
Do. r 1, 1989
Drug Master Files for Bulk November Do.
Do.
Do. Antibiotic Drug
29, Substances
1999
Environmental Assessment July 27, Do.
Do.
Do. of Human Drug and
1998 Biologics Applications
Format and Content for the Septembe Do.
Do.
Do. CMC Section of an Annual r 1, Report
1994
Format and Content of the February Do.
Do.
Do. Chemistry, Manufacturing, 1, 1987 and Controls Section of an Application
Format and Content of the February Do.
Do.
Do. Microbiology Section of 1, 1987 an Application
IND Meetings for Human May 25, Do.
Do.
Do. Drugs and Biologics;
2001 Chemistry, Manufacturing, and Controls Information
INDs for Phase 2 and 3 May 20, Do.
Do.
Do. Studies; Chemistry,
2003 Manufacturing, and Controls Information
Monoclonal Antibodies Used March Do.
Do.
Do. as Reagents in Drug
29, Manufacturing
2001
Nasal Spray and Inhalation July 5, Do.
Do.
Do. Solution, Suspension, and 2002 Spray Drug Products-- Chemistry, Manufacturing, and Controls Documentation
NDAs: Impurities in Drug February Do.
Do.
Do. Substances
25, 2000
PAC-ALTS: Postapproval April Do.
Do.
Do. Changes--Analytical
28, Testing Laboratory Sites 1998
Reviewer Guidance:
November Do.
Do.
Do. Validation of
1994 Chromatographic Methods
Submission Documentation November Do.
Do.
Do. for Sterilization Process 1, 1994 Validation in Applications for Human and Veterinary Drug Products
Submission of Chemistry, November Do.
Do.
Do. Manufacturing, and
1994 Controls Information for Synthetic Peptide Substances
Submitting Documentation February Do.
Do.
Do. for the Manufacturing of, 1, 1987 and Controls for, Drug Products
Submitting Documentation February Do.
Do.
Do. for the Stability of
1, 1987 Human Drugs and Biologics
Submitting Samples and February Do.
Do.
Do. Analytical Data for
1987 Methods Validation
Submitting Supporting February Do.
Do.
N/A Documentation in Drug 1, 1987 Applications for the Manufacture of Drug Products
Submitting Supporting February Do.
Do.
http:// Documentation in Drug 1987
www.fda.g
Applications for the
ov/cder/ Manufacture of Drug
guidance/ Substances
index.htm
[[Page 843]]
SUPAC IR--Immediate-
November Do.
Do.
Do. Release Solid Oral Dosage 1995 Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
SUPAC IR/MR: Immediate January Do.
Do.
Do. Release and Modified
1999 Release Solid Oral Dosage Forms Manufacturing Equipment Addendum
SUPAC-IR Questions and February Do.
Do.
Do. Answers About SUPAC-IR 18, Guidance
1997
SUPAC-MR: Modified Release October Do.
Do.
Do. Solid Oral Dosage Forms 6, 1997 Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
SUPAC-SS--Nonsterile
May 1997 Do.
Do.
Do. Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
The Sourcing and
December Do.
Do.
Do. Processing of Gelatin to 20, Reduce the Potential Risk 2000 Posed by Bovine Spongiform Encephalopathy (BSE)
Analytical Procedures and August Chemistry Do.
Do. Methods Validation:
30, draft Chemistry, Manufacturing, 2000 and Controls Documentation
Botanical Drug Products June 9, Do.
Do.
Do. 2004
Comparability Protocols-- February Do.
Do.
Do. Chemistry, Manufacturing, 25, and Controls Information 2003
Drug Product: Chemistry, January Do.
Do.
Do. Manufacturing, and
28, Controls Information
2003
Drug Substance: Chemistry, January Do.
Do.
Do. Manufacturing, and
7, 2004 Controls Information
Drugs, Biologics, and Septembe Do.
Do.
Do. Medical Devices Derived r 2002 From Bioengineered Plants for Use in Humans and Animals
Interpreting Sameness of July Do.
.......... Do. Monoclonal Antibody
1999 Products Under the Orphan Drug Regulations
Liposome Drug Products: August Do.
Do.
Do. Chemistry, Manufacturing, 2002 and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
Metered Dose Inhaler (MDI) November Do.
Do.
Do. and Dry Powder Inhaler 19, (DPI) Drug Products;
1998 Chemistry, Manufacturing, and Controls Documentation
Stability Testing of Drug June 8, Do.
Do.
Do. Substances and Drug
1998 Products
Submitting Supporting November Do.
Do.
N/A Chemistry Documentation 1, 1991 in Radiopharmaceutical Drug Applications
SUPAC-SS: Nonsterile
January Do.
Do.
http:// Semisolid Dosage Forms 5, 1999
www.fda.g
Manufacturing Equipment
ov/cder/ Addendum
guidance/ index.htm
[[Page 844]]
Antiretroviral Drugs Using October Clinical Do.
Do. Plasma HIV RNA
2002 antimicro Measurements--Clinical
bial Considerations for Accelerated and Traditional Approval
Clinical Development and October Do.
Do.
Do. Labeling of Anti-
26, Infective Drug Products 1992
Clinical Evaluation of Septembe Do.
Do.
Do. Anti-Infective Drugs
r 1, (Systemic)
1977
Preclinical Development of November Do.
Do.
Do. Antiviral Drugs
1990
Acute Bacterial
July 22, Clinical Do.
Do. Exacerbation of Chronic 1998 antimicro Bronchitis; Developing
bial Antimicrobial Drugs for
draft Treatment
Acute Bacterial
July 22, Do.
Do.
Do. Meningitis; Developing 1998 Antimicrobial Drugs for Treatment
Acute Bacterial Sinusitis; July 22, Do.
Do.
Do. Developing Antimicrobial 1998 Drugs for Treatment
Acute or Chronic Bacterial July 22, Do.
Do.
Do. Prostatitis; Developing 1998 Antimicrobial Drugs for Treatment
Acute Otitis Media;
July 22, Do.
Do.
Do. Developing Antimicrobial 1998 Drugs for Treatment
Bacterial Vaginosis;
July 22, Do.
Do.
Do. Developing Antimicrobial 1998 Drugs for Treatment
Catheter-Related
October Do.
Do.
Do. Bloodstream Infections-- 18, Developing Antimicrobial 1999 Drugs for Treatment
Community Acquired
July 22, Do.
Do.
Do. Pneumonia; Developing 1998 Antimicrobial Drugs for Treatment
Complicated Urinary Tract July 22, Do.
Do.
Do. Infections and
1998 Pylonephritis--Developing Antimicrobial Drugs for Treatment
Developing Antimicrobial July 22, Do.
Do.
Do. Drugs--General
1998 Considerations for Clinical Trials
Developing Drugs to Treat March Do.
Do.
Do. Inhalational Anthrax
18, (Post-Exposure)
2002
Empiric Therapy of Febrile July 22, Do.
Do.
Do. Neutropenia--Developing 1998 Antimicrobial Drugs for Treatment
Evaluating Clinical
February Do.
Do.
Do. Studies of Antimicrobials 1997 in the Division of Anti- Infective Drug Products
Lyme Disease--Developing July 22, Do.
Do.
Do. Antimicrobial Drugs for 1998 Treatment
Nosocomial Pneumonia-- July 22, Do.
Do.
Do. Developing Antimicrobial 1998 Drugs for Treatment
Secondary Bacterial
July 22, Do.
Do.
Do. Infections of Acute
1998 Bronchitis--Developing Antimicrobial Drugs for Treatment
Streptococcal Pharyngitis July 22, Do.
Do.
Do. and Tonsillitis--
1998 Developing Antimicrobial Drugs for Treatment
Uncomplicated and
July 22, Do.
Do.
Do. Complicated Skin and Skin 1998 Structure Infections-- Developing Antimicrobial Drugs for Treatment
[[Page 845]]
Uncomplicated Gonorrhea-- July 22, Do.
Do.
Do. Developing Antimicrobial 1998 Drugs for Treatment
Uncomplicated Urinary July 22, Do.
Do.
Do. Tract Infections--
1998 Developing Antimicrobial Drugs for Treatment
Vaccinia Virus--Developing March Do.
Do.
Do. Drugs to Mitigate
2004 Complications From Smallpox Vaccination
Vuvlovaginal Candidiasis-- July 22, Do.
Do.
Do. Developing Antimicrobial 1998 Drugs for Treatment
Acceptance of Foreign March Clinical Do.
Do. Clinical Studies
2001 medical
Calcium DTPA and Zinc DTPA August Do.
Do.
Do. Drug Products--Submitting 2004 a New Drug Application
Cancer Drug and Biological October Do.
Do.
Do. Products--Clinical Data 2001 in Marketing Applications
Clinical Development
February Do.
Do.
Do. Programs for Drugs,
1999 Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
Clinical Development
Septembe Do.
Do.
Do. Programs for MDI and DPI r 19, Drug Products
1994
Clinical Evaluation of April Do.
Do.
Do. Anti-Inflammatory and 1988 Antirheumatic Drugs (adults and children)
Clinical Evaluation of Septembe Do.
Do.
Do. Antianxiety Drugs
r 1, 1977
Clinical Evaluation of Septembe Do.
Do.
Do. Antidepressant Drugs
r 1, 1977
Clinical Evaluation of January Do.
Do.
Do. Antiepileptic Drugs
1, 1981 (adults and children)
Clinical Evaluation of May 1, Do.
Do.
Do. General Anesthetics
1982
Clinical Evaluation of Septembe Do.
Do.
Do. Hypnotic Drugs
r 1, 1977
Clinical Evaluation of May 1982 Do.
Do.
Do. Local Anesthetics
Clinical Evaluation of July Do.
Do.
Do. Psychoactive Drugs in 1979 Infants and Children
Content and Format for May 1996 Do.
Do.
Do. Pediatric Use Supplements
Content and Format of November Do.
Do.
Do. Investigational New Drug 1995 Applications (INDs) for Phase 1 Studies of Drugs, Including Well- Characterized, Therapeutic, Biotechnology-Derived Products
Establishing Pregnancy August Do.
Do.
Do. Exposure Registries
2002
FDA Approval of New Cancer February Do.
Do.
Do. Treatment Uses for
2, 1999 Marketed Drug and Biological Products
FDA Requirements for
January Do.
Do.
Do. Approval of Drugs to
1991 Treat Non-Small Cell Lung Cancer
Format and Content of the July 1, Do.
Do.
Do. Clinical and Statistical 1988 Sections of an Application
Format and Content of the February Do.
Do.
Do. Summary for New Drug and 1, 1987 Antibiotic Applications
Formatting, Assembling and February Do.
Do.
Do. Submitting New Drug and 1, 1987 Antiobiotic Applications
[[Page 846]]
General Considerations for December Do.
Do.
Do. the Clinical Evaluation 1, 1978 of Drugs
General Considerations for Septembe Do.
Do.
Do. the Clinical Evaluation r 1, of Drugs in Infants and 1977 Children
Guidance for the
April Do.
Do.
Do. Development of Vaginal 1995 Contraceptive Drugs (NDA)
IND Exemptions for Studies January Do.
Do.
Do. of Lawfully Marketed Drug 15, or Biological Products 2004 for the Treatment of Cancer
Integration of Dose-
March Do.
Do.
Do. Counting Mechanisms Into 2003 MDI Drug Products
Levothyroxine Sodium
March 8, Do.
Do.
Do. Tablets--In Vivo
2001 Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing
Oncologic Drugs Advisory April Do.
Do.
Do. Committee Discussion on 19, FDA Requirements for
1988 Approval of New Drugs for Treatment of Colon and Rectal Cancer
Oncologic Drugs Advisory April Do.
Do.
Do. Committee Discussion on 1988 FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer
Postmarketing Adverse August Do.
Do.
Do. Experience Reporting for 27, Human Drug and Licensed 1997 Biological Products: Clarification of What to Report
Postmarketing Reporting of March 1, Do.
Do.
Do. Adverse Drug Experiences 1992
Preclinical Development of Septembe Do.
Do.
Do. Immunomodulatory Drugs r 1992 for Treatment of HIV Infection and Associated Disorders
Preparation of
November Do.
Do.
Do. Investigational New Drug 1, 1992 Products (Human and Animal)
Providing Clinical
May 1998 Do.
Do.
Do. Evidence of Effectiveness for Human Drug and Biological Products
Prussian Blue Drug
February Do.
Do.
Do. Products--Submitting a 4, 2003 New Drug Application
Study and Evaluation of July 22, Do.
Do.
Do. Gender Differences in the 1993 Clinical Evaluation of Drugs
Study of Drugs Likely to November Do.
Do.
Do. be Used in the Elderly 1, 1989
Submission of Abbreviated Septembe Do.
Do.
Do. Reports and Synopses in r 13, Support of Marketing
1999 Applications
Abuse Liability Assessment July 1, Clinical Do.
N/A 1990 medical draft
Allergic Rhinitis:
June 21, Do.
Do.
http:// Clinical Development
2000
www.fda.g
Programs for Drug
ov/cder/ Products
guidance/ index.htm
Chronic Cutaneous Ulcer June 28, Do.
Do.
Do. and Burn Wounds--
2000 Developing Products for Treatment
[[Page 847]]
Clinical Development
July Do.
Do.
Do. Programs for Drugs,
1999 Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)
Clinical Evaluation of January Do.
Do.
N/A Anti-Anginal Drugs
1, 1989
Clinical Evaluation of July 1, Do.
Do.
Do. Anti-Arrhythmic Drugs 1985
Clinical Evaluation of May 1, Do.
Do.
Do. Antihypertensive Drugs 1988
Clinical Evaluation of December Do.
Do.
Do. Drugs for the Treatment 1, 1987 of Congestive Heart Failure
Clinical Evaluation of Septembe Do.
Do.
http:// Lipid-Altering Agents in r 1990
www.fda.g
Adults and Children
ov/cder/ guidance/ index.htm
Clinical Evaluation of Septembe Do.
Do.
Do. Weight-Control Drugs
r 24, 1996
Clinical Trial Sponsors on November Do.
Do.
Do. the Establishment and 2001 Operation of Clinical Trial Data Monitoring Committees
Collection of Race and January Do.
Do.
Do. Ethnicity Data in
30, Clinical Trials for FDA- 2003 Regulated Products
Developing Medical Imaging May 19, Do.
Do.
Do. Drug and Biological
2003 Products--2nd draft
Development and Evaluation February Do.
Do.
N/A of Drugs for the
12, Treatment of Psychoactive 1992 Substance Use Disorders
Development of Parathyroid May 2000 Do.
Do.
http:// Hormone for the
www.fda.g
Prevention and Treatment
ov/cder/ of Osteoporosis
guidance/ index.htm
Drugs, Biologics, and Septembe Do.
Do.
Do. Medical Devices Derived r 2002 From Bioengineered Plants for Use in Humans and Animals
Estrogen and Estrogen/ January Do.
Do.
Do. Progestin Drug Products 2003 to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-- Recommendations for Clinical Evaluation
Evaluation of Human
June Do.
Do.
Do. Pregnancy Outcome Data 1999
Evaluation of the Effects November Do.
Do.
Do. of Orally Inhaled and 6, 2001 Intranasal Corticosteroids on Growth in Children
Exercise-Induced
February Do.
Do.
Do. Bronchospasm (EIB)--
20, Development of Drugs to 2002 Prevent EIB
Female Sexual Dysfunction: May 19, Do.
Do.
Do. Clinical Development of 2000 Drug Products for Treatment
Guidance for Institutional March Do.
Do.
Do. Review Boards, Clinical 2000 Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research
Inhalation Drug Products July 26, Do.
Do.
Do. Packaged in Semipermeable 2002 Container Closure Systems
OTC Treatment of Herpes March 8, Do.
Do.
Do. Labialis with Antiviral 2000 Agents
Pediatric Oncology Studies June 21, Do.
Do.
Do. in Response to a Written 2000 Request
[[Page 848]]
Preclinical and Clinical April 1, Do.
Do.
Do. Evaluation of Agents Used 1994 in the Prevention or Treatment of Postmenopausal Osteoporosis
Preparation of IND
Septembe Do.
Do.
N/A Applications for New
r 1, Drugs Intended for the 1991 Treatment of HIV-Infected Individuals
Recommendations for
November Do.
Do.
http:// Complying With the
2000
www.fda.g
Pediatric Rule
ov/cder/ guidance/ index.htm
Drug Metabolism/Drug
April 7, Clinical Do.
Do. Interaction Studies in 1997 pharmacol the Drug Development
ogy Process: Studies In Vitro
Exposure-Response
April Do.
Do.
Do. Relationships--Study
2003 Design, Data Analysis, and Regulatory Applications
Format and Content of the February Do.
Do.
Do. Human Pharmacokinetics 1, 1987 and Bioavailability Section of an Application
In Vivo Metabolism/Drug November Do.
Do.
Do. Interaction Studies-- 24, Study Design, Data
1999 Analysis, and Recommendations for Dosing and Labeling
Pharmacokinetics in
May 30, Do.
Do.
Do. Patients With Impaired 2003 Hepatic Function; Study Design, Data Analysis, and Impact on Dosing and Labeling
Pharmacokinetics in
May 1998 Do.
Do.
Do. Patients with Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing and Labeling
Population
February Do.
Do.
Do. Pharmacokinetics
10, 1999
General Considerations for November Clinical Do.
Do. Pediatric Pharmacokinetic 30, pharmacol Studies for Drugs and 1998 ogy draft Biological Products
A Review of FDA's
May 1990 Compliance Do.
Do. Implementation of the Drug Export Amendments of 1986
Compressed Medical Gases February Do.
Do.
Do. 1989
Computerized Systems Used April Do.
Do.
Do. in Clinical Trials
1999
Expiration Dating and June 27, Do.
Do.
Do. Stability Testing of
1997 Solid Oral Dosage Form Drugs Containing Iron
General Principles of May 1987 Do.
Do.
Do. Process Validation
Good Laboratory Practice June Do.
Do.
Do. Regulations Questions and 1981 Answers
Guidance for Hospitals, March Do.
Do.
Do. Nursing Homes, and Other 2001 Health Care Facilities-- FDA Public Health Advisory
Guideline for Validation December Do.
Do.
Do. of Limulus Amebocyte
1987 Lysate Test as an End- Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
Monitoring of Clinical January Do.
Do.
Do. Investigations
1988
Nuclear Pharmacy Guideline May 1984 Do.
Do.
Do. Criteria for Determining When to Register as a Drug Establishment
Pharmacy Compounding: May 2002 Do.
Do.
Do. Compliance Policy Guide
[[Page 849]]
Possible Dioxin/PCB
August Do.
Do.
Do. Contamination of Drug and 23, Biological Products
1999
Sterile Drug Products June Do.
Do.
Do. Produced by Aseptic
1987 Processing
Street Drug Alternatives March Do.
Do.
Do. 2000
Current Good Manufacturing May 6, Compliance Do.
Do. Practices for Medical 2003 draft Gases
Good Manufacturing
April 1, Do.
Do.
Do. Practice for Positron 2002 Emission Tomography Drug Products
Guidance for IRBs,
May 12, Do.
Do.
Do. Clinical Investigators, 2000 and Sponsors: Exception from Informed Consent Requirements for Emergency Research
Investigating Out of
Septembe Do.
Do.
Do. Specification (OOS) Test r 30, Results for
1998 Pharmaceutical Production
Manufacture, Processing, April Do.
Do.
Do. or Holding of Active
17, Pharmaceutical
1998 Ingredients
Marketed Unapproved Drugs-- October Do.
.......... Do. Compliance Policy Guide 2003
Prescription Drug
June 27, Do.
Do.
Do. Marketing Act Regulations 2002 for Donation of Prescription Drug Samples to Free Clinics
Repackaging of Solid Oral February Do.
Do.
N/A Dosage Form Drug Products 1, 1992
Part 11, Electronic
August Current Do.
http:// Records; Electronic
2003 good
www.fda.g
Signatures--Scope and
manufactu
ov/cder/ Application
ring
guidance/ practices
index.htm (CGMPs)
Comparability Protocols-- Septembe CGMPs Do.
Do. Protein Drug Products and r 2003 draft Biological Products-- Chemistry, Manufacturing, and Controls Information
Formal Dispute Resolution: August Do.
Do.
Do. Scientific and Technical 2003 Issues Related to Pharmaceutical Current Good Manufacturing Practices
Powder Blends and Finished November Do.
Do.
Do. Dosage Units--Stratified 7, 2003 In-Process Dosage Unit Sampling and Assessment
Process Analytical
October Do.
Do.
Do. Technology--A Framework 4, 2004 for Innovative Pharmaceutical Manufacturing and Quality Assurance
Sterile Drug Products October Do.
Do.
Do. Produced by Aseptic
4, 2004 Processing
Providing Electronic
June 27, Electronic Do.
Do. Submissions in Electronic 2002 submissio Format--ANDAs
ns
Regulatory Submissions in January Do.
Do.
Do. Electronic Format;
28, General Considerations 1999
Regulatory Submissions in January Do.
Do.
Do. Electronic Format; New 28, Drug Applications
1999
Providing Regulatory
August Electronic Do.
Do. Submissions in Electronic 2003 submissio Format--Annual Reports
ns draft for NDAs and ANDAs
[[Page 850]]
Providing Regulatory
February Do.
Do.
Do. Submissions in Electronic 2004 Format--Content of Labeling
Providing Regulatory
October Do.
Do.
Do. Submissions in Electronic 22, Format--General
2003 Considerations
Providing Regulatory
August Do.
Do.
Do. Submissions in Electronic 29, Format--Human
2003 Pharmaceutical Product Applications and Related Submissions
Providing Regulatory
May 4, Do.
Do.
Do. Submissions in Electronic 2001 Format--Postmarketing Expedited Safety Reports
Providing Regulatory
June Do.
Do.
Do. Submissions in Electronic 2003 Format--Postmarketing Periodic Adverse Drug Experience Reports
Providing Regulatory
January Do.
Do.
Do. Submissions in Electronic 31, Format, Prescription Drug 2001 Advertising and Promotional Labeling
180-Day Exclusivity When July Generics Do. Multiple Abbreviated New 2003 Drug Applications Are Submitted on the Same Day
Alternate Source of Active December Do.
Do.
Do. Pharmaceutical
12, Ingredients in Pending 2000 ANDAs
ANDAs: Impurities in Drug November Do.
Do.
Do. Substances
1999
Court Decisions, ANDA March Do.
Do.
Do. Approvals, and 180-Day 2000 Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
Letter announcing that the August Do.
Do.
Do. OGD will now accept the 1995 ICH long-term storage conditions as well as the stability studies conducted in the past
Letter describing efforts October Do.
Do.
Do. by the CDER & the ORA to 1994 clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process
Letter on incomplete
April Do.
Do.
Do. Abbreviated Applications, 1994 Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy
Letter on the provision of July Do.
Do.
Do. new information
1992 pertaining to new bioequivalence guidelines and refuse-to-file letters
Letter on the provision of March Do.
Do.
Do. new procedures and
1989 policies affecting the generic drug review process
Letter on the request for November Do.
Do.
Do. cooperation of regulated 1991 industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions
Letter on the response to March Do.
Do.
Do. 12/20/84 letter from the 1985 Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act
[[Page 851]]
Letter to all ANDA and January Do.
Do.
Do. AADA applicants about the 1993 Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse- to-file incomplete submissions as required by the new law
Letter to regulated
August Do.
Do.
Do. industry notifying
1993 interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria, and bioequivalence requirements
Major, Minor, and
December Do.
Do.
Do. Telephone Amendments to 2001 Abbreviated New Drug Applications
Organization of an ANDA March 2, Do.
Do.
Do. 1999
Revising ANDA Labeling May 2000 Do.
Do.
Do. Following Revision of the RLD Labeling
Skin Irritation and
February Do.
Do.
Do. Sensitization Testing of 3, 2000 Generic Transdermal Drug Products
Variations in Drug
December Do.
Do.
Do. Products that May Be
1998 Included in a Single ANDA
ANDAs: Impurities in Drug January Generics Do.
Do. Products
5, 1999 draft
Handling and Retention of May 26, Do.
Do.
Do. Bioavailability and
2004 Bioequivalence Testing Samples
Potassium Chloride
August Do.
Do.
Do. Modified-Release Tablets 7, 2002 and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (revised)
Pharmacology/Toxicology May 2001 Good
Do.
Do. Review Format
review practices (GRP)
Conducting a Clinical November GRP draft Do.
Do. Safety Review of a New 22, Product Application and 1996 Preparing a Report on the Review
Good Review Management July 28, Do.
Do.
Do. Principles for
2003 Prescription Drug User Fee Act Products
E10--Choice of Control May 14, ICH,
Do.
Do. Group and Related Issues 2001 efficacy in Clinical Trials
E11--Clinical
December Do.
Do.
Do. Investigation of
15, Medicinal Products in the 2000 Pediatric Population
E1A--The Extent of
March Do.
Do.
Do. Population Exposure to 1995 Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions
E2A--Clinical Safety Data March Do.
Do.
Do. Management: Definitions 1995 and Standards for Expedited Reporting
E2B--Data Elements for January Do.
Do.
Do. Transmission of
15, Individual Case Safety 1998 Reports
E2BM--Data Elements for April 3, Do.
Do.
Do. Transmission of
2002 Individual Case Safety Reports (revised)
E2BM--Data Elements for May 2004 Do.
Do.
Do. Transmission of Individual Case Safety Reports--Questions and Answers
E2C--Clinical Safety Data May 19, Do.
Do.
Do. Management: Periodic
1997 Safety Update Reports for Marketed Drugs
[[Page 852]]
E2C Addendum--Clinical February Do.
Do.
Do. Safety Data Management: 5, 2004 Periodic Safety Update Reports for Marketed Drugs
E3--Structure and Content July Do.
Do.
Do. of Clinical Study Reports 1996
E4--Dose-Response
November Do.
Do.
Do. Information to Support 1994 Drug Registration
E5--Ethnic Factors in the June Do.
Do.
Do. Acceptability of Foreign 1998 Clinical Data
E6--Good Clinical
May 9, Do.
Do.
Do. Practice: Consolidated 1997 Guideline
E7--Studies in Support of August Do.
Do.
Do. Special Populations:
1994 Geriatrics
E8--General Considerations December Do.
Do.
Do. for Clinical Trials
24, 1997
E9--Statistical Principles Septembe Do.
Do.
Do. for Clinical Trials
r 1998
M2 eCTD: Electronic Common April 2, ICH, joint Do.
Do. Technical Document
2003 safety/ Specification
efficacy (multidis ciplinary )
M3--Nonclinical Safety November Do.
Do.
Do. Studies for the Conduct 25, of Human Clinical Trials 1997 for Pharmaceuticals
M4--Organization of the August Do.
Do.
Do. CTD
2004
M4--The CTD--Efficacy May 2004 Do.
Do.
Do. Questions and Answers
M4--The CTD--General
May 2004 Do.
Do.
Do. Questions and Answers
M4--The CTD--Safety
February Do.
Do.
Do. Questions and Answers 4, 2003
Q1A(R2)--Stability Testing November ICH,
Do.
Do. of New Drug Substances 21, quality and Products
2003
Q1B--Photostability
November Do.
Do.
Do. Testing of New Drug
1996 Substances and Products
Q1C--Stability Testing for May 9, Do.
Do.
Do. New Dosage Forms
1997
Q1D--Bracketing and
January Do.
Do.
Do. Matrixing Designs for 16, Stability Testing of New 2003 Drug Substances and Products
Q1F--Stability Data
June Do.
Do.
Do. Package for the
2004 Registration in Climatic Zones III and IV
Q2A--Text on Validation of March Do.
Do.
Do. Analytical Procedures 1995
Q2B--Validation of
May 19, Do.
Do.
Do. Analytical Procedures: 1997 Methodology
Q3A--Impurities in New February Do.
Do.
Do. Drug Substances
2003
Q3B(R)--Impurities in Drug November Do.
Do.
Do. Products
14, 2003
Q3C--Impurities: Residual December Do.
Do.
Do. Solvents
24, 1997
Q3C--Tables and List
November Do.
Do.
Do. (revised recommendations 2003 for N-Methylpyrrolidone and Tetrahydrofuran)
Q5A--Viral Safety
Septembe Do.
Do.
Do. Evaluation of
r 24, Biotechnology Products 1998 Derived From Cell Lines of Human or Animal Origin
[[Page 853]]
Q5B--Quality of
February Do.
Do.
Do. Biotechnology Products: 1996 Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5C--Quality of
July Do.
Do.
Do. Biotechnological
1996 Products: Stability Testing of Biotechnology/ Biological Products
Q5D--Quality of
Septembe Do.
Do.
Do. Biotechnological/
r 21, Biological Products:
1998 Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products
Q6A--Specifications: Test December Do.
Do.
Do. Procedures and Acceptance 29, Criteria for New Drug 2000 Substances and New Drug Products: Chemical Substances
Q6B--Test Procedures and August Do.
Do.
Do. Acceptance Criteria for 18, Biotechnological/
1999 Biological Products
Q7A--Good Manufacturing August Do.
Do.
Do. Practice for Active
2001 Pharmaceutical Ingredients
S1A--The Need for Long- March ICH,
Do.
Do. Term Rodent
1996 safety Carcinogenicity Studies of Pharmaceuticals
S1B--Testing for
July Do.
Do.
Do. Carcinogenicity of
1997 Pharmaceuticals
S1C--Dose Selection for March Do.
Do.
Do. Carcinogenicity Studies 1995 of Pharmaceuticals
S1C(R)--Dose Selection for December Do.
Do.
Do. Carcinogenicity Studies 4, 1997 of Pharmaceuticals: Addendum on a Limit Dose and Related Notes
S2A--Specific Aspects of April Do.
Do.
Do. Regulatory Genotoxicity 1996 Tests for Pharmaceuticals
S2B--Genotoxicity: A
November Do.
Do.
Do. Standard Battery for
21, Genotoxicity Testing of 1997 Pharmaceuticals
S3A--Toxicokinetics: The March Do.
Do.
Do. Assessment of Systemic 1995 Exposure in Toxicity Studies
S3B--Pharmacokinetics: March Do.
Do.
Do. Repeated Dose Tissue
1995 Distribution Studies
S4A--Duration of Chronic June 25, Do.
Do.
Do. Toxicity Testing in
1999 Animals (Rodent and Nonrodent Toxicity Testing)
S5A--Detection of Toxicity Septembe Do.
Do.
Do. to Reproduction for
r 22, Medicinal Products
1994
S5B--Detection of Toxicity April Do.
Do.
Do. to Reproduction for
1996 Medicinal Products: Addendum on Toxicity to Male Fertility
S6--Preclinical Safety November Do.
Do.
Do. Evaluation of
18, Biotechnology-Derived 1997 Pharmaceuticals
S7A--Safety Pharmacology July 13, Do.
Do.
Do. Studies for Human
2001 Pharmaceuticals
E2D--Postapproval Safety July ICH draft, Do.
Do. Data Management:
2003 efficacy Definitions and Standards for Expedited Reporting
E12A--Principles for
August Do.
Do.
Do. Clinical Evaluation of 9, 2000 New Antihypertensive Drugs
[[Page 854]]
M4--Common Technical
December ICH draft, Do.
Do. Document--Quality:
30, joint Questions and Answers/ 2002 safety/ Location Issues
efficacy (multidis ciplinary )
Submitting Marketing
Septembe Do.
Do.
Do. Appilcations According to r 5, the ICH-CTD Format--
2001 General Considerations
Q1E--Evaluation of
June 14, ICH draft, Do.
Do. Stability Data
2002 quality
S7B--The Nonclinical
June ICH draft, Do.
Do. Evaluation of the
2004 safety Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
Content and Format of INDs November IND
Do.
Do. for Phase 1 Studies of 1995 Drugs; Including Well- Characterized, Therapeutic, Biotechnology-Derived Products
A Revision in Sample
July 15, Industry Do.
N/A Collection Under the
1996 letters Compliance Program Pertaining to Preapproval Inspections
Continuation of a series March 2, Do.
Do.
http:// of letters communicating 1998
www.fda.g
interim and informal
ov/cder/ generic drug policy and
guidance/ guidance. Availability of
index.htm Policy and Procedure Guides, and further operational changes to the generic drug review program
Fifth of a series of
April Do.
Do.
Do. letters providing
1987 informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required
Fourth of a series of October Do.
Do.
Do. letters providing
1986 informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I
Implementation of the Drug October Do.
Do.
Do. Price Competition and 1984 Patent Term Restoration Act. Preliminary Guidance
Implementation Plan USP October Do.
Do.
Do. injection nomenclature 1995
Instructions for Filing April Do.
Do.
N/A Supplements Under the 11, Provisions of SUPAC-IR 1996
Seventh of a series of July Do.
Do.
http:// letters about the Act 1988
www.fda.g
providing guidance on the
ov/cder/ ``180-day exclusivity''
guidance/ provision of section
index.htm 505(j)(4)(B)(iv) of the FD&C Act
Sixth of a series of
April Do.
Do.
Do. informal notice letters 1988 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
Streamlining Initiatives December Do.
Do.
N/A 24, 1996
Supplement to 10/11/84 November Do.
Do.
http:// letter about policies, 1984
www.fda.g
procedures and
ov/cder/ implementation of the Act
guidance/ (Q & A format)
index.htm
Third of a series of
May 1985 Do.
Do.
Do. letters regarding the implementation of the Act
Year 2000 Letter from Dr. October Do.
Do.
Do. Janet Woodcock
19, 1998
Barbiturate, Single Entity- March 1, Labeling Do.
N/A Class Labeling
1981
[[Page 855]]
Content and Format for October Do.
Do.
http:// Geriatric Labeling
5, 2001
www.fda.g
ov/cder/ guidance/ index.htm
Hypoglycemic Oral Agents April 1, Do.
Do.
N/A 1984
Labeling Over-the-Counter October Do.
Do.
http:// Human Drug Products;
18,
www.fda.g
Updating Labeling in
2002
ov/cder/ Reference Listed Drugs
guidance/ and Abbreviated New Drug
index.htm Applications
Local Anesthetics--Class Septembe Do.
Do.
N/A Labeling
r 1, 1982
Clinical Studies Section July 9, Labeling Do.
http:// of Labeling for
2001 draft
www.fda.g
Prescription Drugs and
ov/cder/ Biologics--Content and
guidance/ Format
index.htm
Content and Format of the March 5, Do.
Do.
Do. Adverse Reactions Section 2004 of Labeling for Human Prescription Drugs and Biologics
Labeling for Combined Oral March Do.
Do.
Do. Contraceptives
2004
Labeling for
February Do.
Do.
Do. Noncontraceptive Estrogen 2004 Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms-- Prescribing Information for Health Care Providers and Patient Labeling
OTC Topical Drug Products June Do.
Do.
Do. for the Treatment of
1998 Vaginal Yeast Infections (Vulvovaginal Candidiasis)
Referencing Discontinued October Do.
Do.
Do. Labeling for Listed Drugs 26, in Abbreviated New Drug 2000 Applications
Enforcement Policy on May 1984 OTC
Do.
Do. Marketing OTC Combination Products (CPG 7132b.16)
General Guidelines for OTC Septembe Do.
Do.
Do. Combination Products
r 1978
Labeling OTC Human Drug December Do.
Do.
Do. Products Using a Column 19, Format
2000
Upgrading Category III October Do.
Do.
Do. Antiperspirants to
1978 Category I (43 FR 46728- 46731)
Labeling OTC Human Drug December OTC draft Do.
Do. Products--Submitting
19, Requests for Exemptions 2000 and Deferrals
Labeling OTC Human Drug February Do.
Do.
Do. Products Updating
2001 Labeling in ANDAs
OTC Actual Use Studies July 22, Do.
Do.
N/A 1994
OTC Nicotine Substitutes March 1, Do.
Do.
Do. 1994
Time and Extent
February Do.
Do.
http:// Applications
10,
www.fda.g
2004
ov/cder/ guidance/ index.htm
Carcinogenicity Study May 2002 Pharmacolo Do.
Do. Protocol Submissions
gy/ Toxicolog y
Format and Content of the February Do.
Do.
Do. Nonclinical Pharmacology/ 1987 Toxicology Section of an Application
Immunotoxicology
October Do.
Do.
Do. Evaluation of
2002 Investigational New Drugs
[[Page 856]]
Nonclinical Pharmacology/ October Do.
Do.
Do. Toxicology Development of 1996 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
Photosafety Testing
May 7, Do.
Do.
Do. 2003
Reference Guide for the February Do.
Do.
Do. Nonclinical Toxicity
1989 Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical Studies
Single Dose Acute Toxicity August Do.
Do.
Do. Testing for
1996 Pharmaceuticals
Estimating the Safe
January Pharmacolo Do.
Do. Starting Dose in Clinical 16, gy/ Trials for Therapeutics 2003 Toxicolog in Adult Healthy
y draft Volunteers
Integration of Study
November Do.
Do.
Do. Results to Access
13, Concerns About Human
2001 Reproductive and Developmental Toxicities
Nonclinical Safety
February Do.
Do.
Do. Evaluation of Pediatric 2003 Drug Products
Nonclinical Studies for October Do.
Do.
Do. Development of
2, 2002 Pharmaceutical Excipients
Statistical Aspects of the May 8, Do.
Do.
Do. Design, Analysis, and 2001 Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals
180-Day Generic Drug
June Procedural Do.
Do. Exclusivity Under the 1998 Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
Continuous Marketing
October Do.
Do.
Do. Applications: Pilot 1-- 2003 Reviewable Units for Fast Track Products Under the PDUFA
Continuous Marketing
October Do.
Do.
Do. Applications: Pilot 2-- 2003 Scientific Feedback and Interactions During Drug Development of Fast Track Products Under the PDUFA
Court Decisions, ANDA March Do.
Do.
Do. Approvals, and 180-Day 27, Exclusivity Under the 2000 Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
Disclosure of Materials November Do.
Do.
Do. Provided to Advisory
30, Committees in Connection 1999 with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000
Drug Products Containing June 3, Do.
Do.
Do. Ensulizole, Hypromellose, 2003 Meradimate, Octinoxate, and Octisalate--Labeling Enforcement Policy
Enforcement Policy During November Do.
Do.
Do. Implementation of Section 23, 503A of the Federal Food, 1998 Drug, and Cosmetic Act
Fast Track Drug
July Do.
Do.
Do. Development Programs-- 2004 Designation, Development, and Application Review
Financial Disclosure by March Do.
Do.
Do. Clinical Investigators 2001
Formal Dispute Resolution: February Do.
Do.
Do. Appeals Above the
2000 Division Level
[[Page 857]]
Formal Meetings With
February Do.
Do.
Do. Sponsors and Applicants 2003 For PDUFA Products
Implementation of Section November Do.
Do.
Do. 120 of the Food and Drug 2, 1998 Administration Modernization Act of 1997--Advisory Committees
Implementation of Section July 21, Do.
Do.
Do. 126 of the Food and Drug 1998 Administration Modernization Act of 1997--Elimination of Certain Labeling Requirements
Information Program on January Do.
Do.
Do. Clinical Trials for
27, Serious or Life-
2004 Threatening Diseases and Conditions
Potassium Iodide in
December Do.
Do.
Do. Radiation Emergencies-- 23, Questions and Answers 2002
Potassium Iodide Tablets March 8, Do.
Do.
Do. for Shelf Life Extension 2004 for Federal Agencies and State and Local Governments
Levothyroxine Sodium
July 13, Do.
Do.
Do. Products Enforcement of 2001 August 14, 2001, Compliance Date and Submission of New Applications
National Uniformity for April 9, Do.
Do.
Do. Nonprescription Drugs-- 1998 Ingredient Listing for OTC Drugs
Potassium Iodide as a December Do.
Do.
Do. Thyroid Blocking Agent in 11, Radiation Emergencies 2001
Qualifying for Pediatric Septembe Do.
Do.
Do. Exclusivity Under Section r 1999 505A of the Federal Food, Drug, and Cosmetic Act (revised)
Refusal to File
July 12, Do.
Do.
Do. 1993
Repeal of Section 507 of May 1998 Do.
Do.
Do. the Federal Food, Drug, and Cosmetic Act
Special Protocol
May 17, Do.
Do.
Do. Assessment
2002
Standards for the Prompt May 15, Do.
Do.
Do. Review of Efficacy
1998 Supplements, Including Priority Efficacy Supplements
Guidance for FDA Staff: June 19, Do.
Do.
Do. The Leveraging Handbook; 2003 an Agency Resource for Effective Collaborations
Women and Minorities
July 20, Do.
Do.
Do. Guidance Requirements 1998
Applications Covered by October Procedural Do.
Do. Section 505(b)(2)
1999 draft
Clinical Trial Sponsors On November Do.
Do.
Do. the Establishment and 2001 Operation of Clinical Trial Data Monitoring Committees
PET Drug Applications-- March Do.
Do.
Do. Content and Format for 2000 NDAs and ANDAs
Disclosing Information December Do.
Do.
Do. Provided to Advisory
22, Committees in Connection 1999 with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000
Disclosure of Conflicts of February Do.
Do.
Do. Interest for Special
14, Government Employees
2002 Participating in FDA Product Specific Advisory Committees
[[Page 858]]
Forms for Registration of April Do.
Do.
Do. Producers of Drugs and 2001 Listing of Drugs in Commercial Distribution
Good Review Management July 28, Do.
Do.
Do. Principles for PDUFA
2003 Products
Independent Consultants May 7, Do.
Do.
Do. for Biotechnology
2003 Clinical Trial Protocols
Information Program on January Do.
Do.
Do. Clinical Trials for
27, Serious or Life-
2004 Threatening Diseases and Conditions
Pharmacogenomic Data
January Do.
Do.
Do. Submissions
27, 2004
Postmarketing Safety
March Do.
Do.
Do. Reporting for Human Drug 12, and Biological Products 2001 Including Vaccines
Reports on the Status of April 4, Do.
Do.
Do. Postmarketing Studies-- 2001 Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
Submitting Debarment
October Do.
Do.
Do. Certification Statements 2, 1998
Submitting Marketing
Septembe Do.
Do.
Do. Applications According to r 5, the ICH/CTD Format--
2001 General Considerations
The Use of Clinical Holds April Do.
Do.
Do. Following Clinical
2002 Investigator Misconduct
Sterility Requirements for November Small Do.
Do. Aqueous-Based Drug
7, 2001 entity Products for Oral
complianc Inhalation--Small Entity
e guides Compliance Guide
Applicability of User Fees July 12, User fee Do.
Do. to (1) Applications
1993 Withdrawn Before Filing, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F)
Application, Product, and December Do.
Do.
Do. Establishment Fees:
16, Common Issues and Their 1994 Resolution (revised) (attachment D) (I)
Classifying Resubmissions May 14, Do.
Do.
Do. in Response to Action 1998 Letters
Fees-Exceed-the-Costs June Do.
Do.
Do. Waivers Under the
1999 Prescription Drug User Fee Act
Information Request and November Do.
Do.
Do. Discipline Review Letters 21, Under the Prescription 2001 Drug User Fee Act
Submitting and Reviewing October Do.
Do.
Do. Complete Responses to 26, Clinical Holds (revised) 2000
Document for Waivers of July 16, User fees Do.
Do. and Reductions in User 1993 draft Fees (attachment G)
Submitting Separate
December Do.
Do.
Do. Marketing Applications 2000 and Clinical Data for Purposes of Assessing User Fees §§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§ WITHDRAWALS
In Vivo Bioequivalence December Do.
Do. Studies on Population and 30, Individual Bioequivalence 1987 Studies
Clinical Evaluation of April 1, N/A
N/A Antacid Drugs
1978
Clinical Evaluation of Septembe Do.
Do. Antidiarrheal Drugs
r 1, 1977
[[Page 859]]
Clinical Evaluation of Septembe Do.
Do. Gastric Secretory
r 1, Depressant (GSD) Drugs 1977
Clinical Evaluation of April 1, Do.
Do. Laxative Drugs
1978
Clinical Evaluation of October Do.
Do. Radiopharmaceutical Drugs 1, 1981
FDA Requirements for
June 20, Do.
Do. Approval of Drugs to
1989 Treat Superficial Bladder Cancer
ANDAs: Blend Uniformity August Do.
Do. Analysis
27, 1999
Topical Dermatological June 18, Do.
Do. Drug Products NDAs and 1998 ANDAs--In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies
Clinical Evaluation of March 1, Do.
Do. Combination Estrogen/ 1995 Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal Women
Noncontraceptive Estrogen Septembe Do.
Do. Drug Products--
r 27, Prescribing Information 1999 for Healthcare Providers and Patient Labeling
Chlordiazepoxide
January Do.
Do. Hydrochloride Capsules 1, 1988
Clorazepate Dipotassium March 1, Do.
Do. Capsules/Tablets
1993
Cyproheptadine
December Do.
Do. Hydrochloride Tablets/ 1, 1986 Syrup
Dipivefrin Hydrochloride November Do.
Do. Ophthalmic Solution, 0.1% 2, 1998
Ergoloid Mesylate Tablets January Do.
Do. 1, 1988
Hydroxyzine Hydrochloride December Do.
Do. Injection
1, 1989
Isoetharine Inhalation March 1, Do.
Do. Solution
1989
Meclofenamate Sodium
July 1, Do.
Do. Capsules
1992
Naphazoline Hydrochloride March 1, Do.
Do. Ophthalmic Solution
1989
Niacin Tablets
July 1, Do.
Do. 1992
Phendimetrazine Tartrate February Do.
Do. Capsules/Tablets and
1, 1991 Extended-Release Capsules
Phentermine Hydrochloride August Do.
Do. Capsules/Tablets
1, 1988
Promethazine Hydrochloride March 1, Do.
Do. Tablets
1990
Propantheline Bromide August Do.
Do. Tablets
1, 1988
Pyridoxine Hydrochloride June 1, Do.
Do. Injection
1984
Quinidine Sulfate Capsules October Do.
Do. USP
1, 1995
Sulfamethoxazole and
February Do.
Do. Phenazopyridine
1, 1992 Hydrochloride Tablets
Theophylline Immediate February Do.
Do. Release Oral Dosage Forms 1, 1995
Thiamine Hydrochloride February Do.
Do. Injection
1, 1988
Vitamin A Capsules
February Do.
Do. 1, 1992
Part 11; Electronic
November Do.
Do. Records; Electronic
12, Signatures, Electronic 2002 Copies of Electronic Records
[[Page 860]]
Clinical Evaluation of December Do.
Do. Analgesic Drugs
1, 1992
Using FDA-Approved Patient April Do.
Do. Labeling in Consumer- 23, Directed Print
2001 Advertisements
Guidance Documents Issued by CDRH
Date of
Intended User or Regulatory How to Obtain a Copy Name of Document
Issuance
Activity
of the Document
Guidance for Industry, FDA Staff, and October 4, 2004 FDA, regulated industry, and Division of Small Third Parties; Implementation of the
third parties
Manufacturers, Inspection by Accredited Persons
International and Program Under the Medical Device User
Consumer Assistance, Fee and Modernization Act of 2002;
1-800-638-2041 or 301- Accreditation Criteria
443-6597; or Facts-on- Demand,\1\ 301-827- 0111; or Internet at http://www.fda.gov/ cdrh/
guidance.html
Implementation of Third Party Programs February 2, Do.
Do. Under the FDA Modernization Act of 2001 1997; Final Guidance for Staff, Industry, and Third Parties
Mutual Recognition Agreement Between June 29, 2000 FDA and regulated industry Do. the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; Draft
Draft Guidance for Industry and FDA; July 30, 1999 Do.
Do. Medical Glove Guidance Manual
Guidance for Industry and FDA;
April 14, 1999 Do.
Do. Regulation of Medical Devices; Background Information for International Officials (entire document available on disk)
Guidance for Staff, Industry, and January 6, 1999 Do.
Do. 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)
Medical Device Appeals and Complaints: February 1998 Do.
Do. Guidance on Dispute Resolution
Overview of FDA Modernization Act of February 19, Do.
Do. 1997 Medical Device Provisions
1998
Medical Device Reporting for
March 1997 Do.
Do. Manufacturers
In Vitro Diagnostic Devices: Guidance January 1997 Do.
Do. for the Preparation of 510(k) Submissions (FDA 97-4224)
Medical Device Quality Systems Manual: April 14, 1999 Do.
Do. A Small Entity Compliance Guide
Comparison Chart: 1996 Quality System November 29, Do.
Do. Regulation vs. 1978 Good
1996 Manufacturing Practices Regulation vs. ANSI/ISO/ASQC Q9001-1994 and ISO/ DIS 13485:1996
Premarket Notification: 510(k)--
August 1995 Do.
Do. Regulatory Requirements for Medical Devices (FDA 95-4158)
[[Page 861]]
Labeling--Regulatory Requirements for September 1, Do.
Do. Medical Devices
1989
Impact Resistant Lenses: Questions and September 1987 Do.
Do. Answers (FDA 87-4002)
CDRH Manual for the GGP Regulations; February 9, FDA
Do. Final Guidance for FDA Staff
2001
Human Factors Principles for Medical September 1, FDA, regulated industry
Do. Device Labeling
1993
Human Factors PTC for IDE Devices January 17, Do.
Do. 1997
Write It Right
August 1993 Do.
Do.
Do It By Design--An Introduction to December 1996 Do.
Do. Human Factors in Medical Devices
Guidance for Industry and FDA
July 18, 2000 Do.
Do. Premarket and Design Control Reviewers; Medical Device Use-- Safety: Incorporating Human Factors Engineering into Risk Management
Guidance on Medical Device Patient April 19, 2001 Do.
Do. Labeling; Final Guidance for Industry and FDA Reviewers
Medical Device Reporting for User April 1996 FDA and user facilities
Do. Facilities
Frequently-Asked Questions About the July 6, 2001 FDA, regulated industry, third Do. Reprocessing and Reuse of Single-Use
party, and hospital Devices by Third-Party and Hospital
reprocessors Reprocessors; Final Guidance for Industry and FDA Staff
Frequently-Asked Questions About the July 16, 2003 Do.
Do. Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions
Continuing Education Credit for
March 17, 1998 FDA, accreditation bodies, and Do. Reading/Writing Articles/Papers and
mammography facilities Presenting Courses/Lectures (incorporated into the Policy Guidance Help System (PGHS))
Guidance for Submission of Request for March 26, 1998 Do.
Do. Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b)/4/8, 1998 (incorporated into PGHS)
Guidance for Review of Requests for March 26, 1998 Do.
Do. Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998 (incorporated into PGHS)
Policy and Standard Operating
April 15, 1998 Do.
Do. Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies (incorporated into PGHS)
Guidance for Industry; Requalification May 28, 1998 Do.
Do. for Interpreting Physician's Continuing Experience Requirement (incorporated into PGHS)
Guidance; The Mammography Quality March 19, 1999 Do.
Do. Standards Act Final Regulations; Document 1 (incorporated into PGHS)
[[Page 862]]
Compliance Guidance; The Mammography March 23, 1999 Do.
Do. Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (incorporated into PGHS)
Guidance for Request and Issuance of May 4, 1999 Do.
Do. Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b) (incorporated into PGHS)
Compliance Guidance; The Mammography December 7, Do.
Do. Quality Standards Act Final
1999 Regulations Quality Assurance Documentation (incorporated into PGHS)
Compliance Guidance; The Mammography February 25, Do.
Do. Quality Standards Act Final
2000 Regulations; Document 2 (incorporated into PGHS)
The Mammography Quality Standards Act July 5, 2000 Do.
Do. Final Regulations Modifications to the Policy Guidance Help System 1; Guidance for Industry and FDA (incorporated into PGHS)
Compliance Guidance; The Mammography July 18, 2000 Do.
Do. Quality Standards Act Final Regulations; Document 3 (incorporated into PGHS)
Compliance Guidance; Mammography
November 6, Do.
Do. Facility Survey, Equipment
2000 Evaluation, and Medical Physicist Qualification Requirements Under MQSA; Final (incorporated into PGHS)
The Mammography Quality Standards Act January 24, Do.
Do. Final Regulations; Modifications and 2001 Additions to Policy Guidance Help System 2; Final Guidance for Industry and FDA (incorporated into PGHS)
The Mammography Quality Standards Act May 23, 2001 Do.
Do. Final Regulations Modifications and Additions to Policy Guidance Help System 4; Guidance for Industry and FDA (incorporated into PGHS)
The Mammography Quality Standards Act October 5, 2001 Do.
Do. Final Regulations Modifications to the Policy Guidance Help System Due to the September 11, 2002, Terrorist Attacks; Final Guidance for Industry and FDA (incorporated into PGHS)
The Mammography Quality Standards Act November 5, Do.
Do. Final Regulations Modifications and 2001 Additions to Policy Guidance Help System 3; Guidance for Industry and FDA (incorporated into PGHS)
Compliance Guidance; The Mammography November 5, Do.
Do. Quality Standards Act Final
2001 Regulations--Preparing for MQSA Inspections (incorporated into PGHS)
The Mammography Quality Standards Act March 25, 2002 Do.
Do. Final Regulations Modifications and Additions to Policy Guidance Help System 4; Guidance for Industry and FDA (incorporated into PGHS)
The Mammography Quality Standards Act July 8, 2002 Do.
Do. Final Regulations Modifications and Additions to Policy Guidance Help System 5; Guidance for Industry and FDA (incorporated into PGHS)
[[Page 863]]
The Mammography Quality Standards Act January 28, Do.
Do. Final Regulations Modifications and 2003 Additions to Policy Guidance Help System 7; Guidance for Industry and FDA (incorporated into PGHS)
The Mammography Quality Standards Act August 19, 2003 Do.
Do. Final Regulations Modifications and Additions to Policy Guidance Help System 6 (incorporated into PGHS)
Accidental Radioactive Contamination August 13, 1998 FDA, State and local agencies Do. of Human Food and Animal Feeds: Recommendations to State and Local Agencies
Office of Device Evaluation
FY 2004 MDUFMA Small Business
August 1, 2003 Office of Device Evaluation Do. Qualification Worksheet and Certification; Guidance for Industry and FDA
Premarket Assessment of Pediatric July 24, 2003 Do.
Do. Medical Devices; Draft Guidance for Industry and FDA Staff
Pediatric Expertise for Advisory
June 3, 2003 Do.
Do. Panels; Guidance for Industry and FDA Staff
Premarket Approval Application Filing May 1, 2003 Do.
Do. Review; Guidance for Industry and FDA Staff
Guidance for Industry and FDA; FY 2003 March 27, 2003 Do.
Do. MDUFMA Small Business Qualification Worksheet and Certification
Assessing User Fees: PMA Supplement February 21, Do.
Do. Definitions, Modular PMA Fees, BLA 2003 and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
Determination of Intended Use for December 3, Do.
Do. 510(k) Devices; Guidance for CDRH 2002 Staff
The Least Burdensome Provisions of the October 4, 2002 Do.
Do. FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
Medical Devices Made With
September 6, Do.
Do. Polyvinylchloride (PVC) Using the 2002 Plasticizer di-(2- Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA
Updated 510(k) Sterility Review
August 30, 2002 Do.
Do. Guidance K90-1; Final Guidance for Industry and FDA
Availability of Information Given to July 18, 2001 Do.
Do. Advisory Committee Members in Connection With CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA Staff
Humanitarian Device Exemptions (HDE) July 12, 2001 Do.
Do. Regulation: Questions and Answers; Final Guidance for Industry
Changes or Modifications During the May 29, 2001 Do.
Do. Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
Early Collaboration Meetings Under the February 28, Do.
Do. FDA Modernization Act (FDAMA); Final 2001 Guidance for Industry and for CDRH Staff
[[Page 864]]
Deciding When To Submit a 510(k) for a November 30, Do.
Do. Change to an Existing Wireless
2000 Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry
Guidance on Section 216 of the Food August 9, 2000 Do.
Do. and Drug Administration Modernization Act of 1997
Guidance on Amended Procedures for July 22, 2000 Do.
Do. Advisory Panel Meetings; Final
Guidance on the Use of Standards in March 12, 2000 Do.
Do. Substantial Equivalence Determinations; Final
Guidance for Off-the-Shelf Software September 9, Do.
Do. Use in Medical Devices; Final
1999
Draft Guidance on Evidence Models for September 1, Do.
Do. the Least Burdensome Means to Market 1999
Medical Devices Containing Materials November 16, Do.
Do. Derived from Animal Sources (Except 1998 In Vitro Diagnostic Devices); Final Guidance for FDA Reviewers and Industry
Guidance for the Medical Device
November 6, Do.
Do. Industry on PMA Shell Development and 1998 Modular Review; Final
Guidance for Industry; General/
November 4, Do.
Do. Specific Intended Use; Final
1998
Frequently Asked Questions on the New October 22, Do.
Do. 510(k) Paradigm; Final
1998
Modifications to Devices Subject to August 6, 1998 Do.
Do. Premarket Approval--The PMA Supplement Decision Making Process; Draft
Guidance for Industry; Contents of a July 27, 1998 Do.
Do. Product Development Protocol; Draft
New Model Medical Device Development July 21, 1998 Do.
Do. Process; Final
Guidance for the Content of Premarket May 29, 1998 Do.
Do. Submissions for Software Contained in Medical Devices; Final
Guidance to Industry Supplements to May 20, 1998 Do.
Do. Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final
A New 510(k) Paradigm--Alternate
March 20, 1998 Do.
Do. Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
PMA/510(k) Expedited Review; Guidance March 20, 1998 Do.
Do. for Industry and CDRH Staff; Final
PMA/510(k) Expedited Review G94-4 March 20, 1998 Do.
Do. (blue book memo)
30-Day Notices and 135-Day PMA
February 19, Do.
Do. Supplements for Manufacturing Method 1998 or Process Changes; Guidance for Industry and CDRH (Docket No. 98D- 0080); Final
Guidance on PMA Interactive Procedures February 19, Do.
Do. for Day-100 Meetings and Subsequent 1998 Deficiencies--for Use by CDRH and Industry; Final
[[Page 865]]
New section 513(f)(2)--Evaluation of February 19, Do.
Do. Automatic Class III Designation;
1998 Guidance for Industry and CDRH Staff; Final
Procedures for Class II Device
February 19, Do.
Do. Exemptions from Premarket
1998 Notification Guidance for Industry and CDRH Staff; Final
Guidance on IDE Policies and
January 20, Do.
Do. Procedures; Final
1998
Distribution and Public Availability October 10, Do.
Do. of PMA Summary of Safety and
1997 Effectiveness Data Packages
Kit Certification for 510(k)s
July 1, 1997 Do.
Do.
Convenience Kits Interim Regulatory May 20, 1997 Do.
Do. Guidance
Real-Time Review Program for Premarket April 22, 1997 Do.
Do. Aproval Application (PMA) Supplements
Deciding When to Submit a 510(k) for a January 10, Do.
Do. Change to an Existing Device (K97-1) 1997
Questions and Answers for the FDA September 3, Do.
Do. Reviewer Guidance: Labeling Reusable 1996 Medical Devices for Reprocessing in Health Care Facilities
Memorandum of Understanding Regarding August 9, 1996 Do.
Do. Patient Labeling Review (blue book memo G96-3)
Continued Access to Investigational July 15, 1996 Do.
Do. Devices During PMA Preparation and Review (blue book memo D96- 1)
Document Review by the Office of the June 6, 1996 Do.
Do. Chief Counsel (blue book memo G96-1)
Format for IDE Progress Reports
June 1, 1996 Do.
Do.
Labeling Reusable Medical Devices for April 1, 1996 Do.
Do. Reprocessing in Health Care Facilities: FDA Reviewer Guidance
510(k) Quality Review Program (blue March 29, 1996 Do.
Do. book memo)
Suggested Content for Original IDE February 27, Do.
Do. Application Cover Letter
1996
Indications for Use Statement
January 2, 1996 Do.
Do.
Letter--Vascular Graft Industry
November 22, Do.
Do. (Philip Phillips)
1995
Cover Letter: 510(k) Requirements November 21, Do.
Do. During Firm-Initiated Recalls;
1995 Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo K95-1)
Color Additives for Medical Devices November 15, Do.
Do. (Snesko)
1995
D95-2, Attachment A
September 15, Do.
Do. (Interagency Agreement between FDA 1995 and HCFA)
D95-2, Attachment B (Criteria September 15, Do.
Do. for Categorization of Investigational 1995 Devices (HCFA))
[[Page 866]]
HCFA Reimbursement Categorization September 15, Do.
Do. Determinations for FDA-Approved IDEs 1995
Implementation of the FDA/HCFA
September 15, Do.
Do. Interagency Agreement Regarding
1995 Reimbursement Categorization of Investigational Devices, Attachment A Interagency Agreement, Attachment B Criteria for Catergorization of Investigational Devices, and Attachment C--List (blue book memo D95-2)
Goals and Initiatives for the IDE July 12, 1995 Do.
Do. Program (blue book memo D95- 1)
Memorandum: Electromagnetic
June 13, 1995 Do.
Do. Compatibility for Medical Devices: Issues and Solutions
Use of International Standard ISO- May 1, 1995 Do.
Do. 10993, ``Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'' (replaces G87- 1 8294) (blue book memo)
Premarket Approval Application (PMA) July 8, 1994 Do.
Do. Closure (blue book memo P94- 2)
510(k) Sign-Off Procedures (blue book June 3, 1994 Do.
Do. memo K94-2)
Letter to Industry, Powered Wheelchair/ May 26, 1994 Do.
Do. Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D., M.D.
510(k) Refuse to Accept Procedures May 20, 1994 Do.
Do. (blue book memo K94-1)
IDE Refuse to Accept Procedures (blue May 20, 1994 Do.
Do. book memo D94-1)
PMA/510(k) Triage Review Procedures May 20, 1994 Do.
Do. (blue book memo G94-1)
Preamendments Class III Strategy
April 19, 1994 Do.
Do.
Premarket Notification (510(k)) Status March 7, 1994 Do.
Do. Request Form
Documentation and Resolution of
December 23, Do.
Do. Differences of Opinion on Product 1993 Evaluations (blue book memo G93-1)
510(k) Additional Information
July 23, 1993 Do.
Do. Procedures (blue book memo K93-1)
CDRH's Investigational Device
June 30, 1993 Do.
Do. Exemption (IDE) Refuse to Accept Policy
CDRH's Premarket Notification (510(k)) June 30, 1993 Do.
Do. Refuse to Accept Policy (updated checklist March 14, 1995)
Proposal for Establishing Mechanisms June 30, 1993 Do.
Do. for Setting Review Priorities Using Risk Assesment and Allocating Review Resources
Classified Convenience Kits
April 30, 1993 Do.
Do.
Telephone Communications Between ODE January 29, Do.
Do. Staff and Manufacturers (blue book 1993 memo I93-1)
Preamendment Class III Devices
March 11, 1992 Do.
Do.
Nondisclosure of Financially Sensitive March 5, 1992 Do.
Do. Information (blue book memo I92-1)
[[Page 867]]
Document Review Processing (blue book February 12, Do.
Do. memo I91-1)
1992
4-of-a-Kind PMAs
October 1, 1991 Do.
Do.
Review of 510(k)s for Computer
August 29, 1991 Do.
Do. Controlled Medical Devices (blue book memo K91-1)
Review of Final Draft Medical Device August 29, 1991 Do.
Do. Labeling (blue book memo P91- 4)
Integrity of Data and Information May 29, 1991 Do.
Do. Submitted to ODE (blue book memo I91-2)
Clinical Utility and Premarket
May 3, 1991 Do.
Do. Approval (blue book memo P91- 1)
Panel Review of Premarket Approval May 3, 1991 Do.
Do. Applications (blue book memo P91-2)
PMA Compliance Program (blue book memo May 3, 1991 Do.
Do. P91-3)
Shelf Life of Medical Devices
April 1, 1991 Do.
Do.
Device Labeling Guidance (blue book March 8, 1991 Do.
Do. memo G91-1)
Review and Approval of PMAs of
October 22, Do.
Do. Licensees (blue book memo P86-4)
Consolidated Review of Submissions for October 19, Do.
Do. Diagnostic Ultrasound Equipment,
1990 Accessories and Related Measurement Devices (blue book memo G90- 2)
Consolidated Review of Submissions for October 19, Do.
Do. Lasers and Accessories (blue book 1990 memo G90-1)
Assignment of Review Documents (blue August 24, 1990 Do.
Do. book memo I90-2)
PMA Supplements: ODEs Letter to
April 24, 1990 Do.
Do. Manufacturers; Identifies Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required) (blue book memo P90-1)
Policy Development and Review
February 15, Do.
Do. Procedures (blue book memo I90-1)
Substantial Equivalence (SE) Decision January 1, 1990 Do.
Do. Making Documentation Attached: ``SE'' Decision Making Process (detailed); i.e., The Decision Making Tree
Threshold Assessment of the Impact of January 1, 1990 Do.
Do. Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976
Meetings with the Regulated Industry November 20, Do.
Do. (blue book memo I89-3)
1989
FDA Policy for The Regulation of
November 13, Do.
Do. Computer Products; Draft
1989
Toxicology Risk Assessment Committee August 9, 1989 Do.
Do. (blue book memo G89-1)
Review of IDEs for Feasibility Studies May 17, 1989 Do.
Do. (blue book memo D89-1)
[[Page 868]]
Premarket Notification--Consistency of February 28, Do.
Do. Reviews (blue book memo K89- 1989 1)
Review of Laser Submissions (blue book April 15, 1988 Do.
Do. memo G88-1)
PMA Review Schedules (P87-1); replaced March 31, 1988 Do.
Do. by P94-2
Guideline on Validation of the Limulus December 1, Do.
Do. Amebocyte Lysate (LAL) Test as an End- 1987 Product Endotoxin Test
Necessary Information for Diagnostic November 24, Do.
Do. Ultrasound 510(k); Draft
1987
Limulus Amebocute Lysate; Reduction of October 23, Do.
Do. Samples for Testing
1987
ODE Executive Secretary Guidance
August 7, 1987 Do.
Do. Manual G87-3
Guideline on Sterile Drug Products June 1, 1987 Do.
Do. Produced by Aseptic Processing
Master Files Part III; Guidance on June 1, 1987 Do.
Do. Scientific and Technical Information
ODE Regulatory Information for the May 15, 1987 Do.
Do. Office of Compliance--Information Sharing Procedures (blue book memo G87-2)
Guideline on General Principles of May 1, 1987 Do.
Do. Process Validation
Industry Representatives on Scientific March 27, 1987 Do.
Do. Panel
Panel Review of ``Me-Too'' Devices July 1, 1986 Do.
Do. (blue book memo P86-6)
Guidance on CDRH's Premarket
June 30, 1986 Do.
Do. Notification Review Program (blue book memo K86-3)
Panel Report and Recommendations on April 18, 1986 Do.
Do. PMA Approvals (blue book memo P86-5)
Criteria for Panel Review of PMA
January 30, Do.
Do. Supplements (blue book memo P86-3)
PMAs--Early Review and Preparation of January 27, Do.
Do. Summaries of Safety and Effectiveness 1986 (blue book memo P86-1)
PTC in the Characterization of Cell June 1, 1984 Do.
Do. Lines Used to Produce Biological Products
Application of the Device Good
December 1, Do.
Do. Manufacturing Practice (GMP)
1983 Regulation to the Manufacture of Sterile Devices
Methods for Conducting Recall
June 16, 1978 Do.
Do. Effectiveness Checks
Guidance for Submitting
1997
Do.
Do. Reclassification Petition
Reprocessing and Reuse of Single-Use February 8, Do.
Do. Devices: Review Prioritization
2000 Scheme; Draft
Class II Special Controls Guidance July 17, 2002 Do.
Do. Document: Apnea Monitors; Guidance for Industry and FDA
Class II Special Controls Guidance December 13, Do.
Do. Document: Cutaneous Carbon Dioxide 2002 (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA
[[Page 869]]
Class II Special Controls Guidance October 5, 2001 Do.
Do. Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA
Heated Humidifier Review Guidance August 30, 1991 Do.
Do.
Class II Special Controls Guidance April 22, 2003 Do.
Do. Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
Class II Special Controls Guidance November 12, Do.
Do. Document: Intraoral Devices for
2002 Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA
Class II Special Controls Guidance August 14, 2002 Do.
Do. Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA Reviewers
Class II Special Controls Guidance May 14, 2002 Do.
Do. Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA
Special Control Guidance Document on February 20, Do.
Do. Encapsulated Amalgam, Amalgam Alloy, 2002 and Dental Mercury Labeling; Draft Guidance for Industry and FDA
Overview of Information Necessary for April 21, 1999 Do.
Do. Premarket Notification Submissions for Endosseous Implants; Final
Guidance for the Preparation of
November 27, Do.
Do. Premarket Notifications for Dental 1998 Composites
Dental Cements--Premarket
August 18, 1998 Do.
Do. Notification; Final
Dental Impression Materials--Premarket August 17, 1998 Do.
Do. Notification; Final
OTC Denture Cushions, Pads, Reliners, August 17, 1998 Do.
Do. Repair Kits, and Partially Fabricated Denture Kits; Final
Draft Guidance Document for the
March 3, 1997 Do.
Do. Preparation of Premarket Notification 510(k)s for Dental Alloys
Information Necessary for Premarket December 9, Do.
Do. Notification Submissions for Screw- 1996 Type Endosseous Implants
Guidance Document on Dental Handpieces July 1, 1995 Do.
Do.
Guidance for the Arrangement and
May 16, 1989 Do.
Do. Content of a Premarket Approval (PMA) Application for an Endosseous Implant for Prosthetic Attachment
Supplementary Guidance on Premarket December 31, Do.
Do. Notifications for Medical Devices 2002 With Sharps Injury Prevention Features; Guidance for Industry and FDA
Guidance on Premarket Notifications October 12, Do.
Do. for Intravascular Administration Sets 2000
Neonatal and Neonatal Transport
September 18, Do.
Do. Incubators--Premarket Notifications; 1998 Final
Guidance on the Content of Premarket December 1, Do.
Do. Notification (510(k)) Submissions for 1995 Protective Restraints
[[Page 870]]
Guidance on Premarket Notification March 16, 1995 Do.
Do. (510(k)) Submissions for Short-Term and Long-Term Intravascular Catheters
Guidance on the Content of Premarket April 1, 1993 Do.
Do. Notification (510(k)) Submissions for Hypodermic Single Lumen Needles
Guidance on the Content of Premarket April 1, 1993 Do.
Do. Notification (510(k)) Submissions for Piston Syringes
Guidance on the Content of Premarket March 1, 1993 Do.
Do. Notification (510(k)) Submissions for Clinical Electronic Thermometers
Guidance on the Content of Premarket March 1, 1993 Do.
Do. Notification (510(k)) Submissions for External Infusion Pumps
Guidance on 510(k) Submissions for October 1, 1990 Do.
Do. Implanted Infusion Ports
Surgical Masks--Premarket Notification May 15, 2003 Do.
Do. (510(k)) Submissions; Draft Guidance
Regulatory Status of Disinfectants August 30, 2002 Do.
Do. Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
Premarket Notification (510(k))
March 7, 2002 Do.
Do. Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA
Class II Special Controls Guidance February 7, Do.
Do. Document: Medical Washers and Medical 2002 Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff
Premarket Guidance: Reprocessing and June 1, 2001 Do.
Do. Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff
Premarket Notifications (510(k)) for May 21, 2001 Do.
Do. Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers
Premarket Approval Applications (PMA) March 2, 2001 Do.
Do. for Sharps Needle Destruction Devices; Final Guidance for Industry and FDA
Guidance on the Content and Format of January 3, 2000 Do.
Do. Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final
Guidance for Conducting Stability November 16, Do.
Do. Testing to Support an Expiration Date 1999 Labeling Claim for Medical Gloves; Draft
Premarket Notification (510(k))
January 13, Do.
Do. Submissions for Testing for Skin
1999 Sensitization to Chemicals in Natural Rubber Products; Final
CDRH Regulatory Guidance for Washers June 2, 1998 Do.
Do. and Washer-Disinfectors Intended for Use in Processing Reusable Medical Devices
Testing for Sensitizing Chemicals in July 28, 1997 Do.
Do. Natural Rubber Latex Medical Devices (addendum to 944)
[[Page 871]]
Addendum to Guidance on Premarket September 19, Do.
Do. Notification (510(k)) Submissions for 1995 Sterilizers Intended for Use in Health Care Facilities
Guidance on the Content and Format of October 1, 1993 Do.
Do. Premarket Notification (510(k)) Submissions for Sharps Containers
Guidance on Premarket Notification August 1, 1993 Do.
Do. (510(k)) Submissions for Automated Endoscope Washers, Washer/ Disinfectors, and Disinfectors Intended for Use in Health Care Facilities
Guidance on Premarket Notification August 1, 1993 Do.
Do. (510(k)) Submissions for Surgical Gowns and Surgical Drapes
Guidance on Premarket Notification March 1, 1993 Do.
Do. 510(k) for Sterilizers Intended for Use in Health Care Facilities
Battery Guidance
January 1, 1994 Do.
Do.
Policy for Expiration Dating (DCRND October 30, Do.
Do. RB92-G)
1992
Balloon Valvuloplasty Guidance for the January 1, 1989 Do.
Do. Submission of an IDE Application and a PMA Application
Cardiac Ablation Catheters Generic July 1, 2002 Do.
Do. Arrhythmia Indications for Use; Guidance for Industry
Investigational Device Exemption (IDE) November 8, Do.
Do. Study Enrollment for Cardiac Ablation 2000 of Typical Atrial Flutter; Final Guidance for Industry and FDA Reviewers
Recommended Clinical Study Design for May 7, 1999 Do.
Do. Ventricular Tachycardia Ablation
Non-Automated Sphygmomanometer (Blood November 19, Do.
Do. Pressure Cuff) Guidance Version 1; 1998 Final
Non-Invasive Blood Pressure (NIBP) March 10, 1997 Do.
Do. Monitor Guidance
Electrocardiograph (ECG) Electrode February 11, Do.
Do. 1997
Electrocardiograph (ECG) Lead
February 11, Do.
Do. Switching Adapter
1997
Electrocardiograph (ECG) Surface
February 11, Do.
Do. Electrode Tester
1997
Draft Version Cardiac Ablation
March 1, 1995 Do.
Do. Preliminary Guidance (Data To Be Submitted to the FDA in Support Investigation Device Exemption Application)
Draft Version Electrode Recording March 1, 1995 Do.
Do. Catheter Preliminary Guidance (Data To Be Submitted to the FDA in Support of Premarket Notifications)
Guidance for Annuloplasty Rings 510(k) January 31, Do.
Do. Submissions; Final Guidance for
2001 Industry and FDA Staff
Guidance for Cardiopulmonary Bypass November 29, Do.
Do. Arterial Line Blood Filter 510(k) 2000 Submissions; Final Guidance for Industry and FDA
Guidance for Extracorporeal Blood November 29, Do.
Do. Circuit Defoamer 510(k) Submissions; 2000 Final Guidance for Industry and FDA
[[Page 872]]
Guidance for Cardiopulmonary Bypass November 13, Do.
Do. Oxygenators 510(k) Submissions; Final 2000 Guidance for Industry and FDA Staff
Draft Replacement Heart Valve Guidance October 14, Do.
Do. 1994
Draft Guidance; Human Heart Valve June 21, 1991 Do.
Do. Allografts
Guidance for the Preparation of the April 1, 1990 Do.
Do. Annual Report to the PMA Approved Heart Valve Prostheses
Draft Intravascular Brachytherapy-- May 24, 1996 Do.
Do. Guidance for Data To Be Submitted to FDA in Support of Investigational Device Exemption (IDE) Applications
Draft Guidance for the Submission of May 1, 1995 Do.
Do. Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents
Draft Percutaneous Transluminal
February 7, Do.
Do. Coronary Angioplasty Package Insert 1995 Template
Coronary and Cerebrovascular Guidewire January 1, 1995 Do.
Do. Guidance
Guidance for the Submission of
November 1, Do.
Do. Research and Marketing Applications 2000 for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions
Draft Guidance for Implantable
June 19, 1996 Do.
Do. Cardioverter-Defibrillators
Implantable Pacemaker Testing Guidance January 12, Do.
Do. 1990
Guidance Document for Vascular
November 1, Do.
Do. Prostheses 510(k) Submissions
2000
Guidance for Cardiovascular
November 26, Do.
Do. Intravascular Filter 510(k)
1999 Submissions; Final
Carotid Stent--Suggestions for Content October 26, Do.
Do. of Submissions to FDA in Support of 1996 Investigational Devices Exemption (IDE) Applications
Draft Guidance for the Preparation of August 1, 1993 Do.
Do. Research and Marketing Applications for Vascular Graft Prostheses
Guidance Document for Powered Suction September 30, Do.
Do. Pump 510(k)s
1998
Guidance Document for Surgical Lamp July 13, 1998 Do.
Do. 510(k)s; Final
Electroencephalograph Devices Draft November 3, Do.
Do. Guidance for 510(k) Content
1997
Guidelines for Reviewing Premarket February 1, Do.
Do. Notifications That Claim Substantial 1997 Equivalence to Evoked Response Stimulators
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Electromyograph Needle Electrodes
Guidance on the Content and
June 1, 1995 Do.
Do. Organization of a Premarket Notification for a Medical Laser
[[Page 873]]
Draft 510(k) Guideline for General May 10, 1995 Do.
Do. Surgical Electrosurgical Devices
Guidance for the Preparation of a August 30, 1994 Do.
Do. Premarket Notification for Extended Laparoscopy Devices
Galvanic Skin Response Measurement August 23, 1994 Do.
Do. Devices; Draft Guidance for 510(k) Content
Draft Version 1; Biofeedback Devices; August 1, 1994 Do.
Do. Draft Guidance for 510(k) Content
Draft Version Cranial Perforator
July 13, 1994 Do.
Do. Guidance
Draft Version Neuro Endoscope Guidance July 7, 1994 Do.
Do.
Draft Premarket Notification Review June 1, 1994 Do.
Do. Guidance for Evoked Response Somatosensory Stimulators
Draft Guidance for Arthroscope and May 1, 1994 Do.
Do. Accessory 510(k)s
Class II Special Controls Guidance January 16, Do.
Do. Document; Knee Joint
2003 Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA
Class II Special Controls Guidance July 17, 2002 Do.
Do. Document; Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA
Class II Special Controls Guidance April 30, 2002 Do.
Do. Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis
Class II Special Controls Guidance: October 31, Do.
Do. Shoulder Joint Metal/Polymer/Metal 2000 Nonconstrained or Semiconstrained Porous-Coated Uncemented Prosthesis
Guidance for Spinal System 510(k)s September 27, Do.
Do. 2000
Guidance Document for the Preparation January 13, Do.
Do. of IDEs for Spinal Systems
2000
Guidance Document for Industry and March 18, 1998 Do.
Do. CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft
Draft Guidance Document for the
July 16, 1997 Do.
Do. Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices--The Basic Elements
ORDB 510(k) Sterility Review Guidance July 3, 1997 Do.
Do.
Calcium Phosphate (Ca-P) Coating Draft February 21, Do.
Do. Guidance for Preparation of FDA
1997 Submissions for Orthopedic and Dental Endosseous Implants
Reviewers Guidance Checklist for
February 21, Do.
Do. Intramedullary Rods
1997
Reviewers Guidance Checklist for
February 21, Do.
Do. Orthopedic External Fixation Devices 1997
510(k) Information Needed for
February 20, Do.
Do. Hydroxyapatite Coated Orthopedic
1997 Implants
[[Page 874]]
Guidance Document for Testing
April 20, 1996 Do.
Do. Biodegradable Polymer Implant Devices
Guidance Document for Testing Bone April 20, 1996 Do.
Do. Anchor Devices
Draft Guidance Document for Femoral August 1, 1995 Do.
Do. Stem Prostheses
Draft Guidance Document for Testing May 1, 1995 Do.
Do. Acetabular Cup Prostheses
Guidance Document for Testing Non- May 1, 1995 Do.
Do. Articulating, ``Mechanically Locked,'' Modular Implant Components
Draft Data Requirements for Ultrahigh March 28, 1995 Do.
Do. Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices
Guidance Document for the Preparation January 10, Do.
Do. of Premarket Notification for Ceramic 1995 Ball Hip Systems
Guidance Document for Testing
April 28, 1994 Do.
Do. Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement
Draft Guidance for the Preparation of April 1, 1993 Do.
Do. Premarket Notifications (510(k)s) for Cemented, Semiconstrained Total Knee Prostheses
Guidance Document for the Preparation February 18, Do.
Do. of IDE and PMA Applications for Intra- 1993 Articular Prothetic Knee Ligament Devices
Class II Special Controls Guidance June 3, 2003 Do.
Do. Document; Surgical Sutures; Guidance for Industry and FDA
Guidance for Saline, Silicone Gel, and February 11, Do.
Do. Alternative Breast Implants; Guidance 2003 for Industry and FDA
Class II Special Controls Guidance October 22, Do.
Do. Document; Human Dura Mater; Draft 2002 Guidance for Industry and FDA
Guidance for Resorbable Adhesion
June 18, 2002 Do.
Do. Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry
Guidance Document for Dura Substitute November 9, Do.
Do. Devices; Final Guidance for Industry 2000
Guidance for Neurological Embolization November 1, Do.
Do. Devices
2000
Guidance for the Preparation of a October 14, Do.
Do. Premarket Notification Application 1999 for Processed Human Dura Mater; Final
Guidance for Dermabrasion Devices; March 2, 1999 Do.
Do. Final
Guidance for the Preparation of a March 2, 1999 Do.
Do. Premarket Notification Application for a Surgical Mesh; Final
Guidance for Content of Premarket April 28, 1998 Do.
Do. Notifications for Esophageal and Tracheal Prostheses; Final
Guidance for Testing MR Interaction May 22, 1996 Do.
Do. With Aneurysm Clips
[[Page 875]]
Draft Guidance for the Preparation of April 4, 1995 Do.
Do. IDE Submission for Interactive Wound and Burn Dressing
Draft Guidance for the Preparation of March 31, 1995 Do.
Do. a Premarket Notification for a Non- Interactive Wound and Burn Dressing
Draft Version; Guidance on
September 12, Do.
Do. Biocompatibility Requirements for 1994 Long Term Neurological Implants: Part 3--Implant Model
Protocol for Dermal Toxicity Testing January 1, 1985 Do.
Do. for Devices in Contact With Skin; Draft
Class II Special Controls Guidance June 2, 2003 Do.
Do. Document; Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA
Guidance Document for Powered Muscle June 9, 1999 Do.
Do. Stimulator 510(k)s; Final
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Beds
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Communications Systems (Powered and Nonpowered) and Powered Environmental Control Systems
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Exercise Equipment
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Heating and Cooling Devices
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Immersion Hydrobaths
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Powered Tables and Multifunctional Physical Therapy Tables
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Submerged (Underwater) Exercise Equipment
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification (510(k)) Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
Guide for TENS 510(k) Content; Draft August 1, 1994 Do.
Do.
Draft Version Guidance for Clinical August 20, 1992 Do.
Do. Data To Be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators
Draft Guidance for Cortical Electrode August 10, 1992 Do.
Do. 510(k) Content
Guidance for Studies for Pain Therapy May 12, 1988 Do.
Do. Devices--General Consideration in the Design of Clinical Studies for Pain- Alleviating Devices
[[Page 876]]
Accountability Analysis for Clinical August 4, 1999 Do.
Do. Studies for Ophthalmic Devices; Draft
Guidance Document for Nonprescription October 9, 1998 Do.
Do. Sunglasses; Final
Ophthalmoscope Guidance
July 8, 1998 Do.
Do.
Retinoscope Guidance; Final
July 8, 1998 Do.
Do.
Slit Lamp Guidance; Final
July 8, 1998 Do.
Do.
Discussion Points for Expansion of the September 5, Do.
Do. ``Checklist of Information Usually 1997 Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers;'' Draft Document
Third Party Review Guidance for
January 31, Do.
Do. Phacofragmentation System Device
1997 Premarket Notification (510(k))
Third Party Review Guidance for
January 31, Do.
Do. Vitreous Aspiration and Cutting
1997 Device Premarket Notification (510(k))
Checklist of Information Usually
October 10, Do.
Do. Submitted in an Investigational
1996 Device Exemptions (IDE) Application for Refractive Surgery Lasers (excimer)
Guidance for Manufacturers Seeking March 12, 2000 Do.
Do. Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; Final
Tympanostomy Tubes, Submission
January 14, Do.
Do. Guidance for a 510(k) Premarket
1998 Notification; Final
Guidance for the Arrangement and
May 1, 1990 Do.
Do. Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 Years
Guideline for the Arrangement and May 1, 1990 Do.
Do. Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of Age
Refractive Implants: Guidance for August 1, 2000 Do.
Do. Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; Draft
Intraocular Lens Guidance Document; October 14, Do.
Do. Draft
1999
Guidance on 510(k) Submissions for March 3, 1999 Do.
Do. Keratoprostheses; Final
Aqueous Shunts--510(k) Submissions; November 16, Do.
Do. Final
1998
FDA Guidelines for Multifocal
May 29, 1997 Do.
Do. Intraocular Lens IDE Studies and PMAs
Important Information About Rophae August 20, 1992 Do.
Do. Intraocular Lenses
Guidance for Premarket Submissions of April 10, 2000 Do.
Do. Orthokeratology Rigid Gas Permeable Contact Lenses; Final
Revised Procedures for Adding Lens August 11, 1998 Do.
Do. Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Final
[[Page 877]]
Premarket Notification 510(k) Guidance May 1, 1997 Do.
Do. for Contact Lens Care Products
Premarket Notification (510(k))
June 28, 1994 Do.
Do. Guidance Document for Class II Daily Wear Contact Lenses
New FDA Recommendations and Results of May 30, 1989 Do.
Do. Contact Lens Study (7-day letter)
Class II Special Controls Guidance November 28, Do.
Do. Document; Ingestible Telemetric
2001 Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA
Class II Special Controls Guidance May 16, 2001 Do.
Do. Document; Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers
Guidance for Investigational Device January 16, Do.
Do. Exemptions for Solutions for
2001 Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA Reviewers
Guidance for Industry and CDRH
August 7, 1998 Do.
Do. Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; Final
Guidance for the Content of Premarket August 7, 1998 Do.
Do. Notification for Conventional and High Permeability Hemodialyzers; Final
Guidance for the Content of Premarket February 5, Do.
Do. Notifications for Metal Expandable 1998 Biliary Stents; Final
Guidance for the Content of Premarket May 30, 1997 Do.
Do. Notifications for Water Purification Components and Systems for Hemodialysis
Draft Guidance for Hemodialyzer Reuse October 6, 1995 Do.
Do. Labeling
Class II Special Controls Guidance July 28, 2003 Do.
Do. Document; Breast Lesion Documentation System; Guidance for Industry and FDA Staff
Class II Special Controls Guidance for March 9, 2001 Do.
Do. Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers
Class II Special Controls Guidance July 3, 2000 Do.
Do. Document for Clitoral Engorgement Devices
Draft Guidance for Industry; Electro- August 25, 1999 Do.
Do. optical Sensors for the In Vivo Detection of Cervical Cancer and Its Precursors: Submission Guidance for an IDE/PMA
Devices Used for In Vitro
September 10, Do.
Do. Fertilization and Related Assisted 1998 Reproduction Procedures; Draft
Latex Condoms for Men--Information for July 23, 1998 Do.
Do. 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions
Uniform Contraceptive Labeling; Final July 23, 1998 Do.
Do.
Intrapartum Continuous Monitors for June 14, 1997 Do.
Do. Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document
[[Page 878]]
Letter to Manufacturers of
September 6, Do.
Do. Prescription Home Monitors for
1996 Nonstress Tests
Letter to Manufacturers of
September 5, Do.
Do. Falloposcopes
1996
Thermal Endometrial Ablation Devices March 14, 1996 Do.
Do. (Submission Guidance for an IDE)
Hysteroscopes and Gynecology
March 7, 1996 Do.
Do. Laparoscopes (Submission Guidance for a 510(k))
Hysteroscopes and Laparoscopic
August 1, 1995 Do.
Do. Insufflators (Submission Guidance for a 510(k))
Testing Guidance for Male Condoms Made June 29, 1995 Do.
Do. From New Material (Nonlatex)
Draft Guidance for the Content of May 25, 1995 Do.
Do. Premarket Notifications for Menstrual Tampons
Information for a Latex Condom 510(k) April 13, 1994 Do.
Do. Submission for Obstetrics-Gynecology Devices Branch; Draft
Premarket Testing Guidelines for
November 20, Do.
Do. Falloposcopes
1992
Draft Guidance for the Content of July 29, 1991 Do.
Do. Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions
Premarket Testing Guidelines for
April 4, 1990 Do.
Do. Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases
Guidance (``Guidelines'') for
May 10, 1978 Do.
Do. Evaluation of Hysteroscopic Sterilization Devices
Guidance (``Guidelines'') for
May 1, 1978 Do.
Do. Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)
Guidance (``Guidelines'') for
November 22, Do.
Do. Evaluation of Tubal Occlusion Devices 1977
Guidance (``Guidelines'') for
March 8, 1977 Do.
Do. Evaluation of Fetal Clip Electrode
Guidelines for Evaluation of Nondrug September 28, Do.
Do. IUDs
1976
Criteria for Significant Risk
July 14, 2003 Do.
Do. Investigations of Magnetic Resonance Diagnostic Devices; Guidance for Industry and FDA Staff
Bone Sonometer PMA Applications; Final June 21, 2001 Do.
Do. Guidance for Industry and FDA
Premarket Applications for Digital February 16, Do.
Do. Mammography Systems; Final Guidance 2001 for Industry and FDA
Guidance for the Submission of
August 2, 2000 Do.
Do. Premarket Notifications for Photon- Emitting Brachytherapy Sources
Guidance for the Submission of
July 27, 2000 Do.
Do. Premarket Notifications for Medical Image Management Devices
Guidance for the Submission of 510(k)s August 6, 1999 Do.
Do. for Solid State X-ray Imaging Devices; Final
[[Page 879]]
Guidance for the Submission of
December 3, Do.
Do. Premarket Notifications for Emission 1998 Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Final
Guidance for the Submission of
November 20, Do.
Do. Premarket Notifications for
1998 Radionuclide Dose Calibrators; Final
Harmonic Imaging With/Without
November 16, Do.
Do. Contrast--Premarket Notification; 1998 Final
Guidance for the Submission of
November 14, Do.
Do. Premarket Notifications for Magnetic 1998 Resonance Diagnostic Devices; Final
Information for Manufacturers Seeking September 30, Do.
Do. Marketing Clearance of Diagnostic 1997 Ultrasound Systems and Transducers
Letter: Notice to Manufacturers of September 25, Do.
Do. Bone Mineral Densitometers
1997
Simplified 510(k) Procedures for
December 21, Do.
Do. Certain Radiology Devices: 12/21/93 1993 letter from L. Yin, ODE/DRAERD, to NEMA
Draft Guidance for Review of Bone November 9, Do.
Do. Densitometer 510(k) Submissions
1992
Reviewer Guidance for Automatic X-Ray February 1, Do.
Do. Film Processor 510(k)
1990
Guidance for the Content of Premarket August 9, 2000 Do.
Do. Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi
Guidance for the Content of Premarket January 16, Do.
Do. Notifications for Penile Rigidity 2000 Implants; Final
Guidance for the Content of Premarket November 30, Do.
Do. Notifications for Intracorporeal
1998 Lithotripters; Final
CDRH Interim Regulatory Policy for September 10, Do.
Do. External Penile Rigidity Devices
1997
Draft Guidance for Preclinical and November 29, Do.
Do. Clinical Investigations of Urethral 1995 Bulking Agents Used in the Treatment of Urinary Incontinence
Draft Guidance for the Clinical
November 2, Do.
Do. Investigation of Urethral Stents
1995
Draft 510(k) Checklist for Endoscopic August 16, 1995 Do.
Do. Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology
Draft 510(k) Checklist for Urological August 1, 1995 Do.
Do. Irrigation System and Tubing Set
Draft 510(k) Checklist for Endoscopic June 22, 1995 Do.
Do. Light Sources Used in Gastroenterology and Urology
Draft 510(k) Checklist for Non-
June 6, 1995 Do.
Do. Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence
Draft Guidance for Preparation of PMA May 1, 1995 Do.
Do. Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)
[[Page 880]]
Draft Guidance for the Content of March 17, 1995 Do.
Do. Premarket Notifications for Endoscopes Used in Gastroenterology and Urology
Draft 510(k) Checklist for Condom February 23, Do.
Do. Catheters
1995
Draft Guidance for Clinical
November 11, Do.
Do. Investigations of Devices Used for 1994 the Treatment of Benign Prostatic Hyperplasia (BPH)
Checklist for Mechanical Lithotripters November 1, Do.
Do. and Stone Dislodgers Used in
1994 Gastroenterology and Urology
510(k) Checklist for Sterile
September 19, Do.
Do. Lubricating Jelly Used With
1994 Transurethral Surgical Instruments
Guidance for the Content of Premarket September 12, Do.
Do. Notifications for Conventional and 1994 Antimicrobial Foley Catheters
Guidance for the Content of Premarket July 29, 1994 Do.
Do. Notifications for Urodynamic/ Uroflowmetry Systems
Guidance for the Content of Premarket June 7, 1994 Do.
Do. Notifications for Urine Drainage Bags
Draft Guidance Outline--PTC for
November 30, Do.
Do. Clinical Studies for Vasovasostomy 1993 Devices
Draft Guidance for Preparation of PMA March 16, 1993 Do.
Do. Applications for Penile Inflatable Implants
Draft Guidance for Preparation of PMA March 16, 1993 Do.
Do. Applications for Testicular Prostheses
Guidance for the Content of Premarket February 10, Do.
Do. Notifications for Biopsy Devices Used 1993 in Gastroenterology and Urology
Guidance for the Content of Premarket February 10, Do.
Do. Notifications for Ureteral Stents 1993
Draft Guidance for the Content of January 24, Do.
Do. Premarket Notifications for
1992 Urological Balloon Dilatation Cathethers
Draft of Suggested Information for January 18, Do.
Do. Reporting Extracorporeal Shock Wave 1991 Lithotripsy Device Shock Wave Measurements
Draft Guidance to Firms on Biliary August 2, 1990 Do.
Do. Lithotripsy Studies
Office of In Vitro Diagnostic Device Evaluation and Safety
Analyte Specific Reagents; Small
February 26, Do.
Do. Entity Compliance Guidance; Guidance 2003 for Industry
Assessing the Safety/Effectiveness of October 1, 1988 Do.
Do. Home-Use In Vitro Diagnostic Devices (IVDs): Draft PTC Regarding Labeling and Premarket Submissions
Data for Commercialization of Original June 10, 1996 Do.
Do. Equipment Manufacturer, Secondary and Generic Reagents for Automated Analyzers
Determination of Intended Use for December 3, Do.
Do. 510(k) Devices; Guidance for CDRH 2002 Staff
Guidance for Administrative Procedures August 14, 2000 Do.
Do. for CLIA Categorization
[[Page 881]]
Guidance for Clinical Laboratory
March 1, 2001 Do.
Do. Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA
Guidance for Industry; Abbreviated February 22, Do.
Do. 510(k) Submissions for In Vitro
1999 Diagnostic Calibrators; Final
Guidance on Labeling for Laboratory June 24, 1999 Do.
Do. Tests; Draft
Letter to IVD Manufacturers on
December 22, Do.
Do. Streamlined PMA; Final
1997
PTC for Collection of Data in Support September 26, Do.
Do. of In Vitro Device Submissions for 1994 510(k) Clearance
PTC for Review of Calibration and February 1, Do.
Do. Quality Control Labeling for In Vitro 1996 Diagnostic Devices (cover letter dated March 14, 1996)
PTC Guidance Document on Assayed and February 3, Do.
Do. Unassayed Quality Control Material; 1999 Draft
Premarket Approval Application Filing May 1, 2003 Do.
Do. Review; Guidance for Industry and FDA Staff
Breath Nitric Oxide Test System; Class July 7, 2003 Do.
Do. II Special Controls Guidance Document
Class II Special Control Guidance November 30, Do.
Do. Document for B-Type Natriuretic
2000 Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers
Class II Special Controls Guidance September 16, Do.
Do. Document; Cyclosporine and Tacrolimus 2002 Assays; Guidance for Industry and FDA
Draft Guidance for Prescription Use of November 14, Do.
Do. Drugs of Abuse Assays Premarket
2000 Notifications
Draft Guidance on the Labeling for December 21, Do.
Do. Over-the-Counter Sample Collection 1999 Systems for Drugs of Abuse Testing
Guidance for 510(k)s on Cholesterol July 14, 1995 Do.
Do. Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home Use
Guidance for Industry In Vitro
July 6, 1998 Do.
Do. Diagnostic Bicarbonate/Carbon Dioxide Test System; Final
Guidance for Industry In Vitro
July 6, 1998 Do.
Do. Diagnostic Chloride Test System; Final
Guidance for Industry In Vitro
July 2, 1998 Do.
Do. Diagnostic Creatinine Test System; Final
Guidance for Industry In Vitro
July 6, 1998 Do.
Do. Diagnostic Glucose Test System; Final
Guidance for Industry In Vitro
July 6, 1998 Do.
Do. Diagnostic Potassium Test System; Final
Guidance for Industry In Vitro
July 6, 1998 Do.
Do. Diagnostic Sodium Test System; Final
Guidance for Industry In Vitro
July 6, 1998 Do.
Do. Diagnostic Urea Nitrogen Test System; Final
Guidance for Industry; In Vitro
July 20, 1998 Do.
Do. Diagnostic C-Reactive Protein Immunological Test System
[[Page 882]]
Guidance for Over-the-Counter (OTC) July 22, 2000 Do.
Do. Human Chorionic Gonadotropin (hCG) 510(k)s
Guidance for Over-the-Counter (OTC) July 22, 2000 Do.
Do. Ovulation Predictor 510(k)s
Over-the-Counter (OTC) Screening Tests November 14, Do.
Do. for Drugs of Abuse; Guidance for
2000 Premarket Notifications
PTC for Portable Blood Glucose
February 20, Do.
Do. Monitoring Devices Intended for
1996 Bedside Use in the Neonate Nursery
Review Criteria for Assessment of In August 31, 1995 Do.
Do. Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies
Review Criteria for Assessment of February 14, Do.
Do. Portable Blood Glucose In Vitro
1996 Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology
Review Criteria for Assessment of November 6, Do.
Do. Professional Use Human Chorionic
1996 Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
510(k) Submissions for Coagulation June 19, 2003 Do.
Do. Instruments; Guidance for Industry and FDA Staff
Class II Special Control Guidance August 23, 2000 Do.
Do. Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket Notifications
Class II Special Controls Guidance December 4, Do.
Do. Document: Premarket Notifications for 2001 Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA
Document for Special Controls for April 28, 1999 Do.
Do. Erythropoietin Assay Premarket Notifications (510(k)s); Final
Draft Guidance Document for 510(k) July 29, 1992 Do.
Do. Submission of Fecal Occult Blood Tests
Draft Guidance Document for 510(k) September 30, Do.
Do. Submission of Glycohemoglobin
1991 (Glycated or Glycosylated) Hemoglobin for IVDs
Draft Guidance Document for 510(k) September 1, Do.
Do. Submission of Immunoglobulins A, G, 1992 M, D and E Immunoglobulin System In Vitro Devices
Draft Guidance for 510(k) Submission September 26, Do.
Do. of Lymphocyte Immunophenotyping IVDs 1991 Using Monoclonal Antibodies
Draft; Premarketing Approval Review September 10, Do.
Do. Criteria for Premarket Approval of 1992 Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) with Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bind
Guidance Document for the Submission September 19, Do.
Do. of Tumor Associated Antigen Premarket 1996 Notification (510(k)) to FDA
Guidance for Submission of
June 3, 1998 Do.
Do. Immunohistochemistry Applications to the FDA; Final
In Vitro Diagnostic Fibrin Monomer April 27, 1999 Do.
Do. Paracoagulation Test; Final
[[Page 883]]
Multiplex Tests for Heritable DNA February 27, Do.
Do. Markers, Mutations, and Expression 2003 Patterns; Draft Guidance for Industry and FDA Reviewers
PTC for Cervical Cytology Devices July 25, 1994 Do.
Do.
PTC for Hematology Quality Control September 30, Do.
Do. Materials
1997
Radioallergosorbent Test (RAST)
August 22, 2001 Do.
Do. Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDA
Review Criteria for Assessment of July 15, 1994 Do.
Do. Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test Methodologies
Review Criteria for Assessment of July 15, 1991 Do.
Do. Cytogenetic Analysis Using Automated and Semi-Automated Chromosome Analyzers
Review Criteria for Assessment of February 21, Do.
Do. Rheumatoid Factor (RF) In Vitro
1997 Diagnostic Devices Using Enzyme- Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate Nephelometry
Review Criteria for Blood Culture August 12, 1991 Do.
Do. Systems
Review Criteria for In Vitro
August 1, 1992 Do.
Do. Diagnostic Devices for Detection of IGM Do Antibodies to Viral Agents
Review Criteria for In Vitro
February 1, Do.
Do. Diagnostic Devices for the Assessment 1994 of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA)
Review Criteria for In Vitro
February 15, Do.
Do. Diagnostic Devices That Utilize
1996 Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)
Review Criteria for the Assessment of September 1, Do.
Do. Anti-Nuclear Antibodies (ANA) In
1992 Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD), and Enzyme Linked Immunosorbant Assay (ELISA)
Class II Special Controls Guidance February 5, Do.
Do. Document; Antimicrobial
2003 Susceptibility Test (AST) Systems; Guidance for Industry and FDA
Draft Review Criteria for Nucleic Acid June 14, 1993 Do.
Do. Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms
Premarket Approval Applications for In April 27, 2001 Do.
Do. Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for Industry and FDA
Review Criteria for Assessment of October 30, Do.
Do. Antimicrobial Susceptibility Test 1996 Discs
[[Page 884]]
Review Criteria for Assessment of In January 1, 1992 Do.
Do. Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical Specimens
Review Criteria for Assessment of In July 6, 1993 Do.
Do. Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. (Tuberculosis (TB))
Review Criteria for Assessment of September 17, Do.
Do. Laboratory Tests for the Detection of 1992 Antibodies to Helicobacter pylori
Review Criteria for Devices Assisting May 31, 1990 Do.
Do. in the Diagnosis of C. Difficile Associated Diseases
Review Criteria for Devices Intended December 30, Do.
Do. for the Detection of Hepatitis B `e' 1991 Antigen and Antibody to HBe
Review Criteria for Premarket Approval May 15, 1992 Do.
Do. of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
Office of Surveillance and Biometrics
PMA Review Statistical Checklist
(no date
Do.
Do. available)
Statistical Aspects of Submissions to June 1, 1984 Do.
Do. FDA: A Medical Device Perspective (also includes as appendix the article ``Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions'')
Statistical Guidance for Clinical January 1, 1996 Do.
Do. Trials of Nondiagnostic Medical Devices
MDR Guidance Document: Remedial Action September 26, Industry and FDA
Do. Exemption; Final
2001
Guidance on Adverse Event Reporting April 24, 2001 Industry
Do. for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use
MDR Guidance Document No. 1--IOL-- August 7, 1996 Do.
Do. E1996004; Final
Common Problems: Baseline Reports and January 1, 1997 Do.
Do. Medwatch Form 3500A
Medical Device Reporting: An Overview; April 1, 1996 Do.
Do. Final
Instructions for Completing FDA Form December 15, Do.
Do. 3500A With Coding Manual for Form 1995 3500A (MEDWATCH) (MDR); Final
MEDWATCH FDA Form 3500A for Use by June 1, 1993 Industry and user facilities Do. User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR); Final
Variance from Manufacturer Report July 16, 1996 Industry
Do. Number Format (MDR letter); Final
Instructions for Completing Form 3417: March 31, 1997 Do.
Do. Medical Device Reporting Baseline Report (MDR); Final
Medical Device Reporting--Alternative October 19, Do.
Do. Summary Reporting (ASR) Program;
2000 Guidance for Industry
Addendum to the Instructions for
June 9, 1999 Do.
Do. Completing FDA Form 3500A With Coding Manual (MEDWATCH) (MDR); Final
[[Page 885]]
Needlesticks--Medical Device Reporting November 12, Industry and user facilities Do. Guidance
2002
Guidance to Sponsors on the
June 9, 1993 Industry and FDA reviewers Do. Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads)
Guidance on Criteria and Approaches November 2, Do.
Do. for Postmarket Surveillance
1998
Guidance on Procedures to Determine February 19, FDA reviewers
Do. Application of Postmarket
1998 Surveillance Strategies (FDAMA); Final
Guidance on Procedures for Review of February 19, Do.
Do. Postmarket Surveillance Submissions 1998 (FDAMA); Final
Guidance for Industry and FDA Staff; November 2, Industry and FDA reviewers Do. SMDA to FDAMA: Guidance on FDA's
1998 Transition Plan for Existing Postmarket Surveillance Protocols (FDAMA); Final
Amendment to Guidance on Discretionary March 30, 1994 Do.
Do. Postmarket Surveillance on Pacemaker Leads; Final
Guidance for Industry on the Testing February 2, Do.
Do. of Metallic Plasma Sprayed Coatings 2000 on Orthopedic Implants to Support Reconsideration of Postmarket
Office of Compliance
Commercial Distribution/Exhibit Letter March 11, 1992 Do.
Do.
FDA Guide for Validation of Biological January 1, 1986 Do.
Do. Indicator Incubation Time
Guide for Establishing and Maintaining March 1, 1988 Do.
Do. a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)
General Principles of Software
January 11, Do.
Do. Validation; Draft Guidance
2002
Guidance on Medical Device Tracking May 23, 2003 Do.
Do. (FDAMA); Guidance for Industry and FDA Staff
Compliance Program Guidance Manual: February 7, Do.
Do. Inspection of Medical Devices; Draft 2001
Procedures for Laboratory Compliance May 1, 1986 Do.
Do. Testing of Television Revivers--Part of TV Packet
Guidance on Quality System Regulation February 3, Do.
Do. Information for Various Premarket 2003 Submissions; Draft
Surveillance and Detention Without July 26, 2000 Do.
Do. Physical Examination of Surgeons' and/ or Patient Examination Gloves; Guidance for Industry
Manufacturers/Assemblers of Diagnostic October 13, Do.
Do. X-Ray Systems: Enforcement Policy for 1993 Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)
Guidance for the Submission of Initial January 1, 1982 Do.
Do. Reports on Diagnostic X-Ray Systems and Their Major Components
[[Page 886]]
Exemption From Reporting and
September 16, Do.
Do. Recordkeeping Requirements for
1981 Certain Sunlamp Product Manufacturers
Letter to Medical Device Industry on May 17, 1993 Do.
Do. Endoscopy and Laparoscopy Accessories (Galdi)
Clarification of Radiation Control March 1, 1989 Do.
Do. Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)
CPG 7133.19: Retention of Microwave March 1, 1995 Do.
Do. Oven Test Record/Cover Letter: August 24, 1981; Retention of Records Required by 21 CFR 1002
A Guidance for the Submission of
March 1, 1996 Do.
Do. Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting Device
A Guide for the Submission of an
March 1, 1996 Do.
Do. Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use
A Guide for the Submission of
March 1, 1996 Do.
Do. Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammography X-Ray Systems
Compliance Program Guidance Manual; March 15, 2000 Do.
Do. Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA Staff
Information Disclosure by
April 2, 2001 Do.
Do. Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA
Guide for Submission of Information on April 1, 1971 Do.
Do. Accelerators Intended to Emit X- Radiation Required Pursuant to 21 CFR 1002.10
Abbreviated Report on Radiation Safety August 1, 1995 Do.
Do. for Microwave Products (Other Than Microwave Ovens)--e.g., Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security Systems
Guide for Preparing Reports on
March 1, 1985 Do.
Do. Radiation Safety of Microwave Ovens
Reporting Guide for Laser Light Shows September 1, Do.
Do. and Displays (21 CFR 1002) (FDA 88- 1995 8140)
Guide for Filing Annual Reports for X- July 1, 1980 Do.
Do. Ray Components and Systems
Reporting and Compliance Guide for October 1, 1995 Do.
Do. Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information, and Guidance
Revised Guide for Preparing Annual September 1, Do.
Do. Reports on Radiation Safety Testing 1995 of Laser and Laser Light Show Products (replaces FDA 82-8127)
Guide for Preparing Abbreviated
September 1, Do.
Do. Reports of Microwave and RF Emitting 1996 Electronic Products Intended for Medical Use
[[Page 887]]
Letter to Manufacturers and Importers October 31, Do.
Do. of Microwave Ovens: Information
1988 Requirements for Cookbooks and User and Service Manuals
Abbreviated Report on Radiation Safety August 1, 1995 Do.
Do. of Nonmedical Ultrasonic Products
Guide for Preparing Product Reports September 1, Do.
Do. for Medical Ultrasound Products
1996
Letter to Manufacturers, Distributors, February 23, Do.
Do. and Importers of Condom Products
1994
Letter to Manufacturers, Importers, February 13, Do.
Do. and Repackagers of Condoms for
1989 Contraception or Sexually-Transmitted Disease Prevention (Holt)
Letter to Condom Manufacturers and April 5, 1994 Do.
Do. Distributors
Letter to Manufacturers/Repackers April 22, 1994 Do.
Do. Using Cotton
Guide for Preparing Product Reports September 1, Do.
Do. for Lasers and Products Containing 1995 Lasers
Compliance Guide for Laser Products September 1, Do.
Do. (FDA 86-8260)
1985
Condoms: Inspection and Sampling at April 8, 1987 Do.
Do. Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska memo to field on April 8, 1987)
Dental Hand Piece Sterilization (dear September 28, Do.
Do. doctor letter)
1992
Latex Labeling Letter (Johnson)
March 18, 1993 Do.
Do.
Pesticide Regulation Notice 94-4: June 30, 1994 Do.
Do. Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDA
Letter to Industry, Powered Wheelchair May 10, 1993 Do.
Do. Manufacturers, from RM Johnson
Hazards of Volume Ventilators and September 15, Do.
Do. Heated Humidifiers
1993
Manufacturers and Initial Distributors February 3, Do.
Do. of Sharps Containers and Destroyers 1994 Used by Health Care Professionals
Ethylene Oxide; Ethylene Chlorohydrin; June 23, 1978 Do.
Do. and Ethylene Glycol: Proposed Maximum Residue Limits and Maximum Levels of Exposure
Letter to Manufacturers and Users of October 10, Do.
Do. Lasers for Refractive Surgery
1996 (excimer)
Shielded Trocars and Needles Used for August 23, 1996 Do.
Do. Abdominal Access During Laparoscopy
Surveillance and Detention Without August 14, 2000 Do.
Do. Physical Examination of Condoms; Draft Guidance for Industry
All U.S. Condom Manufacturers,
April 7, 1987 Do.
Do. Importers, and Repackagers
Manufacturers and Initial Distributors May 23, 1996 Do.
Do. of Hemodialyzers
[[Page 888]]
Laser Light Show Safety--Who's
May 1, 1986 Do.
Do. Responsible? (FDA 86-8262)
Suggested State Regulations for
January 1, 1982 Do.
Do. Control of Radiation; Volume II; Nonionizing Radiation--Lasers (FDA Pub. No. 83-8220)
Letter to All Foreign Manufacturers May 28, 1981 Do.
Do. and Importers of Electronic Products For Which Applicable FDA Performance Standards Exist
Guide for Submission of Information on March 1, 1973 Do.
Do. Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10
Guide for Submission of Information on April 30, 1974 Do.
Do. Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10
Guidance for the Submission of Cabinet February 1, Do.
Do. X-Ray System Reports Pursuant to 21 1975 CFR 1020.40
Guide for Preparing Annual Reports in October 1, 1987 Do.
Do. Radiation Safety Testing of Electronic Products (General)
Computerized Devices/Processes
May 1, 1992 Do.
Do. Guidance--Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes
Guide for Preparing Product Reports August 1, 1996 Do.
Do. for Ultrasonic Therapy Products (Physical Therapy Only)
Guide for Submission of Information on November 1, Do.
Do. Industrial Radiofrequency Dielectric 1980 Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81- 8137)
Guide for Preparing Annual Reports for September 1, Do.
Do. Ultrasonic Therapy Products
1996
Guide for Preparing Annual Reports on September 1, Do.
Do. Radiation Safety Testing of Sunlamps 1995 and Sunlamp Products (replaces FDA 82- 8127)
Guide for Preparing Annual Reports on September 1, Do.
Do. Radiation Safety Testing of Mercury 1995 Vapor (replaces FDA 82-8127)
Quality Control Guide for Sunlamp September 1, Do.
Do. Products (FDA 88-8234)
1984
Guide for the Submission of Initial December 1, Do.
Do. Reports on Computed Tomography X-Ray 1985 Systems
Guide for Preparing Product Reports on September 1, Do.
Do. Sunlamps and Sunlamp Products (21 CFR 1995 1002)
Letter: Policy on Maximum Timer
June 25, 1985 Do.
Do. Interval and Exposure Schedule for Sunlamp Products
Reporting Guide for Product Reports on September 1, Do.
Do. High Intensity Mercury Vapor
1995 Discharge Lamps (21 CFR 1002)
Quality Control Practices for
May 1, 1980 Do.
Do. Compliance With the Federal Mercury Vapor Lamp Performance Standard
Keeping Up With the Microwave
March 1, 1990 Do.
Do. Revolution (FDA Publication No. 91- 4160)
[[Page 889]]
Quality Assurance Guidelines for
February 1, Do.
Do. Hemodialysis Devices
1991
Letter to Manufacturers and Importers March 28, 1980 Do.
Do. of Microwave Ovens--Open Door Operation of Microwave Ovens as a Result of Oven Miswiring
Reporting of New Model Numbers to June 14, 1983 Do.
Do. Existing Model Families
Import: Radiation-Producing Electronic November 1, Do.
Do. Products (FDA 89-8008)
1988
Unsafe Patient Lead Wires and Cables September 3, Do.
Do. 1993
Application of a Variance From 21 CFR July 1, 1998 Do.
Do. 1040.11(c) for a Laser Light Show, Display, or Device (form FDA 3147)
Letter to Trade Association: Reuse of December 27, Do.
Do. Single-Use or Disposable Medical
1995 Devices
Design Control Guidance for Medical March 11, 1997 Do.
Do. Device Manufacturers
Keeping Medical Devices Safe from July 1, 1995 Do.
Do. Electromagnetic Interference
Safety of Electrically Powered
September 18, Do.
Do. Products: Letter to Medical Devices 1996 and Electronic Products Manufacturers from Lilliam Gill and BHB Correction Memo
Enforcement Priorities for Single-Use August 14, 2000 Do.
Do. Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff
Labeling for Electronic Anti-theft August 15, 2000 Do.
Do. Systems; Final Guidance for Industry
Wireless Medical Telemetry Risks and September 27, Do.
Do. Recommendations; Final Guidance for 2000 Industry
Policy on Warning Label Required on June 25, 1985 Do.
Do. Sunlamp Products
Policy on Lamp Compatibility
September 2, Do.
Do. (Sunlamps)
1986
Office of Science and Technology
Guidance on Frequently Asked Questions December 21, Do.
Do. on Recognition of Consensus Standards 1998 (FDAMA)
Guidance on the Recognition and Use of February 19, Do.
Do. Consensus Standards; appendix A
1998 (FDAMA)
CDRH Standard Operating Procedures for August 6, 1999 Do.
Do. the Identification and Evaluation of Candidate Consensus Standard for Recognition
Guidance for Industry and FDA
May 6, 1999 Do.
Do. Reviewers: Guidance on Immunotoxicity Testing §§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§ WITHDRAWN GUIDANCES
Medical Devices Made With
September 6, N/A
N/A Polyvinylchloride (PVC) Using the 2002 Plasticizer di-(2- Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA
[[Page 890]]
Draft Guidance on Evidence Models for September 1, Do.
Do. the Least Burdensome Means to Market 1999
Modifications to Devices Subject to August 6, 1998 Do.
Do. Premarket Approval--The PMA Supplement Decision Making Process; Draft
Guidance for Industry; Contents of a July 27, 1998 Do.
Do. Product Development Protocol; Draft
New Model Medical Device Development July 21, 1998 Do.
Do. Process; Final
Document Review by the Office of the June 6, 1999 Do.
Do. Chief Counsel (blue book memo G96-1)
Letter: Vascular Graft Industry
November 22, Do.
Do. (Philip Phillips)
1995
Color Additives for Medical Devices November 15, Do.
Do. (Snesko)
1995
PMA/510(k) Triage Review Procedures May 20, 1994 Do.
Do. (blue book memo G94-1)
Proposal for Establishing Mechanisms June 30, 1993 Do.
Do. for Setting Review Priorities Using Risk Assessment and Allocating Review Resources
4-of-a-Kind PMAs
October 1, 1999 Do.
Do.
Review of 510(k)s for Computer
August 29, 1991 Do.
Do. Controlled Medical Devices (blue book memo K91-1)
Review of Final Draft Medical Device August 29, 1991 Do.
Do. Labeling (blue book memo P91- 4)
Clinical Utility and Premarket
May 3, 1991 Do.
Do. Approval (blue book memo P91- 1)
Review and Approval of PMAs of
October 22, Do.
Do. Licensees (blue book memo P86-4)
PMA Supplements: ODEs Letter to
April 24, 1990 Do.
Do. Manufacturers; Identifies Situation Which May Require the Submission of a PMA Supplement (blue book memo P90-1)
FDA Policy for the Regulation of
November 13, Do.
Do. Computer Products; Draft
1989
PMA Review Schedules (P87-1) (replaced March 31, 1988 Do.
Do. by P94-2)
Necessary Information for Diagnostic November 24, Do.
Do. Ultrasound 510(k); Draft
1987
Guideline on Sterile Drug Products June 1, 1987 Do.
Do. Produced by Aseptic Processing
ODE Regulatory Information for the May 15, 1987 Do.
Do. Office of Compliance; Information Sharing Procedures (blue book memo G87-2)
Panel Review of ``Me-Too'' Devices July 1, 1986 Do.
Do. (blue book memo P86-6)
Criteria for Panel Review of PMA
January 30, Do.
Do. Supplements (blue book memo P86-3)
[[Page 891]]
PMAs-Early Review and Preparation of January 27, Do.
Do. Summaries of Safety and Effectiveness 1986 (blue book memo P86-1)
Draft Guidance for the Preparation of March 3, 1997 Do.
Do. Premarket Notification 510(k)s for Dental Alloys
Premarket Guidance; Reprocessing and June 1, 2001 Do.
Do. Reuse of Single-Use Devices; Draft
Guidance for Conducting Stability November 16, Do.
Do. Testing to Support an Expiration Date 1999 Labeling Claim for Medical Gloves; Draft
Draft Version Cardiac Ablation
March 1, 1995 Do.
Do. Preliminary Guidance (Data To Be Submitted to the FDA in Support Investigation Device Exemption Application)
Draft Version Electrode Recording March 1, 1995 Do.
Do. Catheter Preliminary Guidance (Data To Be Submitted to the FDA in Support of Premarket Notifications)
Draft Replacement Heart Valve Guidance October 14, Do.
Do. 1994
Draft Guidance on Human Heart Valve June 21, 1991 Do.
Do. Allografts
Draft Intravascular Brachytherapy-- May 24, 1996 Do.
Do. Guidance for Data To Be Submitted to FDA in Support of Investigational Device Exemption (IDE) Applications
Draft Guidance for the Submission of May 1, 1995 Do.
Do. Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents
Draft Percutaneous Transluminal
February 7, Do.
Do. Coronary Angioplasty Package Insert 1995 Template
Draft Guidance for Implantable
June 19, 1996 Do.
Do. Cardioverter-Defibrillators
Draft Guidance for the Preparation of August 1, 1993 Do.
Do. Research and Marketing Applications for Vascular Graft Prostheses
Electroencephalograph Devices Draft November 3, Do.
Do. Guidance for 510(k) Content
1997
Draft 510(k) Guideline for General May 10, 1995 Do.
Do. Surgical Electrosurgical Devices
Galvanic Skin Response Measurement August 23, 1994 Do.
Do. Devices; Draft Guidance for 510(k) Content
Draft Version 1; Biofeedback Devices; August 1, 1994 Do.
Do. Draft Guidance for 510(k) Content
Draft Version Cranial Perforator
July 13, 1994 Do.
Do. Guidance
Draft Version Neuro Endoscope Guidance July 7, 1994 Do.
Do.
Draft Premarket Notification Review June 1, 1994 Do.
Do. Guidance for Evoked Response Somatosensory Stimulators
Draft Guidance for Arthroscope and May 1, 1994 Do.
Do. Accessory 510(k)s
[[Page 892]]
Guidance Document for Industry and March 18, 1998 Do.
Do. CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Draft
Draft Guidance for Preparation of July 16, 1997 Do.
Do. Premarket Notification (510(k)) Applications for Orthopedic Devices: The Basic Elements
Calcium Phosphate (Ca-P) Coating Draft February 21, Do.
Do. Guidance for Preparation of FDA
1997 Submission for Orthopedic and Dental Endosseous Implants
Draft Guidance Document for Femoral August 1, 1995 Do.
Do. Stem Prostheses
Draft Guidance Document for Testing May 1, 1995 Do.
Do. Acetabular Cup Prostheses
Draft Data Requirements for Ultrahigh March 23, 1995 Do.
Do. Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices
Draft Guidance for the Preparation of April 1, 1993 Do.
Do. Premarket Notifications (510(k)s) for Cemented, Semiconstrained Total Knee Prostheses
Draft Guidance for the Preparation of April 4, 1995 Do.
Do. IDE Submission for Interactive Wound and Burn Dressing
Draft Guidance for the Preparation of March 31, 1995 Do.
Do. a Premarket Notification for a Non- Interactive Wound and Burn Dressing
Draft Version; Guidance on
September 12, Do.
Do. Biocompatibility Requirements for 1994 Long Term Neurological Implants: Part 3--Implant Model
Protocol for Dermal Toxicity Testing January 1, 1985 Do.
Do. for Devices in Contact with Skin; Draft
Guide for TENS 510(k) Content; Draft August 1, 1994 Do.
Do.
Draft Version Guidance for Clinical August 20, 1992 Do.
Do. Data To Be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators
Draft Guidance for Cortical Electrode August 10, 1999 Do.
Do. 510(k) Content
Accountability Analysis for Clinical August 4, 1999 Do.
Do. Studies for Ophthalmic Devices; Draft
Refractive Implants: Guidance for August 1, 2000 Do.
Do. Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; Draft
Intraocular Lens Guidance Document; October 14, Do.
Do. Draft
1999
Draft Guidance for Hemodialyzer Reuse October 6, 1995 Do.
Do. Labeling
Draft Guidance for Industry: Electro- August 25, 1999 Do.
Do. Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors; Submission Guidance for an IDE/PMA
Devices Used for In Vitro
September 10, Do.
Do. Fertilization and Related Assisted 1988 Reproduction Procedures; Draft
[[Page 893]]
Intrapartum Continuous Monitors for June 14, 1997 Do.
Do. Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft Document
Draft Guidance for the Content of May 25, 1995 Do.
Do. Premarket Notifications for Menstrual Tampons
Information for a Latex Condom 510(k) April 13, 1994 Do.
Do. Submission for Obstetrics-Gynecology Devices Branch; Draft
Premarket Testing Guidelines for
November 20, Do.
Do. Falloscopes
1992
Draft Guidance for the Content of July 29, 1991 Do.
Do. Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions
Draft Guidance for Review of Bone November 9, Do.
Do. Densitometer 510(k) Submissions
1992
Draft Guidance for Preclinical and November 29, Do.
Do. Clinical Investigations of Urethral 1995 Bulking Agents Used in the Treatment of Urinary Incontinence
Draft Guidance for Clinical
November 2, Do.
Do. Investigation of Urethral Stents
1995
Draft 510(k) Checklist for Endoscopic August 16, 1995 Do.
Do. Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology
Draft 510(k) Checklist for Urological August 1, 1995 Do.
Do. Irrigation System and Tubing Set
Draft 510(k) Checklist for Endoscopic June 22, 1995 Do.
Do. Light Sources Used in Gastroenterology and Urology
Draft 510(k) Checklist for Non-
June 6, 1995 Do.
Do. Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence
Draft Guidance for Preparation of PMA May 1, 1995 Do.
Do. Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)
Draft Guidance for the Content of March 17, 1995 Do.
Do. Premarket Notifications for Endoscopes Used in Gastroenterology and Urology
Draft 510(k) Checklist for Condom February 23, Do.
Do. Catheters
1995
Draft Guidance for Clinical
November 11, Do.
Do. Investigations of Devices Used for 1994 the Treatment of Benign Prostatic Hyperplasia (BPH)
Draft Guidance Outline; PTC for
November 30, Do.
Do. Clinical Studies for Vasovasostomy 1993 Devices
Draft Guidance for Preparation of PMA March 16, 1993 Do.
Do. Applications for Penile Inflatable Implants
Draft Guidance for Preparation of PMA March 16, 1993 Do.
Do. Applications for Testicular Prostheses
Draft Guidance for the Content of January 24, Do.
Do. Premarket Notifications for
1992 Urological Balloon Dilatation Catheters
Draft of Suggested Information for January 18, Do.
Do. Reporting Extracorporeal Shock Wave 1991 Lithotripsy Device Shock Wave Measurements
[[Page 894]]
Draft Guidance to Firms on Biliary August 2, 1990 Do.
Do. Lithotripsy Studies
Statistical Aspects of Submissions to June 1, 1984 Do.
Do. FDA: A Medical Device Perspective (also includes as appendix the article ``Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions'')
Guidance to Sponsors on the
June 9, 1993 Do.
Do. Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads)
Amendment to Guidance on Discretionary March 30, 1994 Do.
Do. Postmarket Surveillance on Pacemaker Leads; Final
Premarketing Approval Review Criteria September 10, Do.
Do. for Premarket Approval of Estrogen 1992 (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) With Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bind; Draft
Premarket Approval Applications for In April 27, 2001 Do.
Do. Vitro diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, Other HCV-Associated Disease; Draft Guidance for Industry and FDA
Premarket Approval (PMA) Manual
January 1998 Do.
Do.
SMDA Changes--PMA Manual Insert
April 17, 1992 Do.
Do.
Investigational Device Exemptions June 1, 1996 Do.
Do. (IDE) Manual (FDA 96-4159)
510(k) Manual--Premarket Notification: August 1, 1995 Do.
Do. 510(k)--Regulatory Requirements for Medical Devices
Guidance Document for the Preparation July 26, 1995 Do.
Do. of Premarket Notification [510(k)] Applications for Beds
\1\See Internet address for Facts-on-Demand number.
Guidance Documents Issued by CFSAN
Intended User Date of
or
How to Obtain Name of Document
Issuance Regulatory a Copy of the Activity Document
Compliance Policy Guides August General
http:// Manual
2000;
publications www.cfsan.fda
updated in
.gov/ April 2001
guidance.html
Compliance Programs Guidance March 1995 Do.
Do. Manual
FDA Recall Policy
2002
Do.
Do.
Guidance for FDA Staff; The 2003
Do.
Do. Leveraging Handbook; An Agency Resource for Effective Collaborations
Guidance for Small
2002
Do.
Do. Businesses; Submission of Comments for CFSAN Rulemaking
Investigations Operations May 1996 Do.
Do. Manual
Regulatory Procedures Manual August 1997 Do.
Do.
[[Page 895]]
Draft Guidance: Channels of July 2003 Chemical and Do. Trade Policy for
pesticide Commodities With Residues
contaminants of Pesticide Chemicals, For
publications Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency
Channels of Trade Policy for June 2002 Do.
Do. Commodities With Vinclozolin Residues
FDA Recommendations for January Do.
Do. Sampling and Testing Yellow 2001 Corn and Dry-Milled Yellow Corn Shipments for Cry9C Protein Residues
Channels of Trade Policy for December Do.
Do. Commodities With Methyl 2000 Parathion Residues
Action Levels for Poisonous 2000
Do.
Do. or Deleterious Substances in Human Food and Animal Feed
Pesticides Analytical Manual 1999
Do.
Do.
FDA Advisory for
September Do.
Do. Deoxynivanol (DON) in
1993 Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal Feed
FDA's Cosmetic Labeling October Cosmetic Do. Manual
1991
publications
Draft Guidance: Labeling for December 2, Do.
Do. Topically Applied Cosmetic 2002 Products Containing Alpha Hydroxy Acids as Ingredients
Interim Procedures for
July 10, Dietary
Do. Qualified Health Claims in 2003
supplements the Labeling of
publications Conventional Human Food and Human Dietary Supplements
Interim Evidence-Based
July 10, Do.
Do. Ranking System for
2003 Scientific Data
Structure/Function Claims: January 9, Do.
Do. Small Entity Compliance 2002 Guide
Statement of Identity,
January Do.
Do. Nutrition Labeling, and 1999 Ingredient Labeling of Dietary Supplements Small Entity Compliance Guide
Significant Scientific
December Do.
Do. Agreement in the Review of 1999 Health Claims for Conventional Foods and Dietary Supplements
Notification of a Health July 1998 Do.
Do. Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
Iron-Containing Supplements October 17, Do.
Do. and Drugs: Label Warning 2003 Statements: Small Entity Compliance Guide
Providing Regulatory
July 2001 Food and Do. Submissions in Electronic
color Format; General
additives Considerations
publications
Providing Food and Color July 2001 Do.
Do. Additive Petitions in Electronic Format
Electronic Submission Forms July 2001 Do.
Do.
FDA's Policy for Foods
1995
Do.
Do. Developed by Biotechnology
Partial List of Enzyme
2001
Do.
Do. Preparations That Are Used in Foods
Partial List of
2001
Do.
Do. Microorganisms and Microbial-Derived Ingredients That Are Used in Food
Use of Antibiotic Resistance September Do.
Do. Marker Genes in Transgenic 1998 Plants
Enzyme Preparations:
January Do.
Do. Chemistry Recommendations 1993 for Food Additive and GRAS Affirmation Petitions
[[Page 896]]
Guidance for Submitting 1996
Do.
Do. Requests Under 21 CFR 170.39; Threshold of Regulation for Substances Used in Food Contact Articles
PTC for the Use of Recycled December Do.
Do. Plastics in Food Packaging: 1992 Chemistry Considerations
How to Submit a GRAS Notice April 17, Do.
Do. 1997
Recommendations for
May 1993 Do.
Do. Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient Petitions
Statement of Policy; Foods May 1992 Do.
Do. Derived from New Plant Varieties; Notice
Guidelines for the
1996
Do.
Do. Preparation of Petition Submissions
Guidelines for Approval of 1996
Do.
Do. Color Additives in Contact Lenses Intended as Colors
FDA Recommendations for January Do.
Do. Submission of Chemical and 1997 Technological Data on Color Additives for Food, Drug, or Cosmetic Use
Estimating Exposure to
September Do.
Do. Direct Food Additive and 1995 Chemical Contaminants in the Diet
Toxicological Principles for 1982
Do.
Do. the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as redbook I)
Toxicological Principles for April 2004 Do.
Do. the Safety of Food Ingredients (redbook 2000)
Draft Guidance; Preparing a September Do.
Do. Claim of Categorical
17, 2003 Exclusion or an Environmental Assessment for Submission to CFSAN
Environmental Assessment March 1987 Do.
Do. Technical Handbook
Toxicological Testing of 1983
Do.
Do. Food Additives
Guidance on Consultation October Do.
Do. Procedures Foods Derived 1997 From New Plant Varieties
Bovine Spongiform
1997
Do.
Do. Encephalopathy (BSE) in Products for Human Use
Food Additive Petition
January Do.
Do. Expedited Review; Guidance 1999 for Industry and CFSAN
Antimicrobial Food Additives July 1999 Do.
Do. Guidance
Preparation of Premarket May 2002 Do.
Do. Notifications for Food Contact Substances (Food Contact Notifications (FCN)): Administrative Recommendations
Preparation of Food Contact April 2002 Do.
Do. Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations
Preparation of Premarket April 2002 Do.
Do. Notifications for Food Contact Substances: Toxicology Recommendations
A Food Labeling Guide
May 1997 Food labeling Do. publications
Food Labeling: Trans Fatty August 20, Do.
Do. Acids in Nutrition
2003 Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance Guide
[[Page 897]]
Qualified Health Claims in December Do.
Do. the Labeling of
18, 2002 Conventional Foods and Dietary Supplements
Draft Guidance; Voluntary January Do.
Do. Labeling Indicating Whether 2001 Foods Have or Have Not Been Developed Using Bioengineering
Small Business Food Labeling June 1996 Do.
Do. Exemption
Food Labeling: Questions and August 1994 Do.
Do. Answers (volume I)
Food Labeling: Questions and February Do.
Do. Answers (volume II)
1996
Fair Packaging and Labeling June 1978 Do.
Do. Act Manual
Implementation of Section 2002
Do.
Do. 10809 of the Farm Security and Investment Act of 2002, Public Law No. 107-171, Sec. 10809 (2002), Regarding the Petition Process to Request Approval of Labeling for Foods That Have Been Treated by Irradiation
FDA Nutrition Labeling
March 1998 Do.
Do. Manual--A Guide for Developing and Using Databases
Guidelines for Determining October 1, Do.
Do. Metric Equivalents of
1993 Household Measures
Food Labeling--Safe Handling July 2001 Do.
Do. Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution; Small Entity Compliance Guide
Exemptions From the Warning October 7, Do.
Do. Label Requirement for
2002 Juice--Recommendations for Effectively Achieving a 5- Log Pathogen Reduction
Food Labeling--Serving Sizes July 2001 Do.
Do. Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide
Bacteriological Analytical 1992
Food
Do. Manual (7th ed.)
processing publicatons
Bacteriological Analytical 2001
Do.
Do. Manual Online
Questions and Answers
August 6, Food and Do. Regarding Registration of 2004
cosmetic Food Facilities (4th ed.)
security publications
Cosmetics Processors and December Do.
Do. Transporters: Cosmetics 17, 2003 Security Preventive Measures Guidance
Retail Food Stores and Food December Do.
Do. Service Establishments: 17, 2003 Food Security Preventive Measures Guidance
What You Need to Know About November Do.
Do. Registration of Food
25, 2003 Facilities
What You Need to Know About November Do.
Do. Prior Notice of Imported 25, 2003 Food Shipments
Necessity of the Use of Food July 17, Do.
Do. Product Categories in
2003 Registration of Food Facilities
Dairy Farms, Bulk Milk
July 11, Do.
Do. Transporters, Bulk Milk 2003 Transfer Stations, and Fluid Milk Processors: Food Security Preventive Measures Guidance
Food Producers, Processors, March 21, Do.
Do. and Transporters: Food
2003 Security Preventive Measures Guidance
Importers and Filers: Food March 21, Do.
Do. Security Preventive
2003 Measures Guidance
[[Page 898]]
Compliance Policy Guide; 2003
Do.
Do. Guidance for FDA Staff on Registration of Food Facilities
Compliance Policy Guide; 2003
Do.
Do. Guidance for FDA Staff on Prior Notice of Imported Foods
Prior Notice of Imported May 2004 Imports and Do. Food Questions and Answers
exports (2nd ed.)
publications
Prior Notice of Imported August 2004 Do.
Do. Food: Harmonized Tariff Schedule Codes Flagged With Prior Notice Indicators
Guidance for Industry and May 23, Do.
Do. FDA; Establishing and
2003 Maintaining a List of U.S. Dairy Product Manufacturers/ Processors With Interest in Exporting to Chile
FDA Food Importer's Guide 1985
Do.
Do. for Low-Acid Canned and Acidified Foods
Guidance for Industry; FDA 2002
Do.
Do. Export Certificates
Draft Guidance; Regulatory November 5, Do.
Do. Procedures Manual, chapter 2002 9, subchapter: Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned
Guidelines Concerning
1985
Infant
Do. Notification and Testing of
formula Infant Formula
publications
Guidelines for Evaluation of 1988
Do.
Do. the Safety and Suitability of New Infant Formulas for Feeding Preterm Infants
Clinical Testing of Infant 1988
Do.
Do. Formulas With Respect to Nutritional Suitability for Term Infants
Guidelines for Evaluation of 1990
Do.
Do. the Safety and Suitability of Infant Formulas for Feeding Infants With Allergic Diseases
Guidelines for the Clinical 1987
Do.
Do. Evaluation of New Products Used in the Dietary Management of Infants, Children, and Pregnant Women With Metabolic Disorders
The Juice HACCP Regulation: September Juice
Do. Questions and Answers
4, 2003 publications
Standardized Training
June 2003 Do.
Do. Curriculum for Application of HACCP Principles to Juice Processing
Bulk Transport of Juice April 24, Do.
Do. Concentrates and Certain 2002 Shelf Stable Juices
Juice HACCP Small Entity April 4, Do.
Do. Compliance Guide
2003
Draft Guidance; Juice HACCP March 3, Do.
Do. Hazards and Control
2004 Guidance (1st ed.)
Apple Juice, Apple Juice October Do.
Do. Concentrates, and Apple 2001 Juice Products-- Adulteration With Patulin
The Juice HACCP Regulation: August 31, Do.
Do. Questions and Answers
2001
FDA Food Importer's Guide 1985
Low-acid and Do. for Low-Acid Canned and
acidified Acidified Foods
foods publications
Grade ``A'' Pasteurized Milk May 15, Milk
Do. Ordinance (2001 revision) 2002
sanitation publications
Importation of PMO Defined April 11, Do.
Do. Dairy Products (M-I-00-4) 2000
Evaluation of Milk
1995
Do.
Do. Laboratories
[[Page 899]]
Methods of Making Sanitation 1999
Do.
Do. Ratings of Milk Supplies
Procedures Governing the 1999
Do.
Do. Cooperative State-Public Health Service/FDA Program for Certification of Interstate Milk Shippers
Frozen Dessert Processing 1989
Do.
Do. Guidelines
Dry Milk Ordinance
1995
Do.
Do.
Pasteurized Milk Ordinance 1999
Do.
Do.
Fumonisin Levels in Human November 9, Natural
Do. Foods and Animal Feeds
2001
toxins publications
List of Products for Each October 8, Nutrition and Do. Product Category
1992
food science publications
Label Declaration of
June 10, Do.
Do. Allergenic Substances in 1996 Foods; Notice to Manufacturers
Guidance on Labeling of February Do.
Do. Foods That Need
24, 1997 Refrigeration by Consumers
Interim Guidance on the February Do.
Do. Voluntary Labeling of Milk 10, 1994 and Milk Products That Have Not Been Treated With Recombinant Bovine Somatropin
Guide to Minimize Microbial October 26, Produce
Do. Food Safety Hazards for 1998
publications Fresh Fruits and Vegetables
Reducing Microbial Food October Do.
Do. Safety Hazards for Sprouted 1999 Seeds
Sampling and Microbial
October Do.
Do. Testing of Spent Irrigation 1999 Water During Sprout Production
Retail Food Stores and Food December Retail food Do. Service Establishments: 17, 2003 protection Food Security Preventive
publications Measures Guidance
Foods--Adulteration
February Sanitation Do. Involving Hard or Sharp 1999
publications Foreign Objects
Defect Action Levels (DALs) May 1998 Do.
Do.
Action Levels for Poisonous 2000
Do.
Do. or Deleterious Substances in Human Food and Feed
Refusal of Inspection or July 2001 Seafood
Do. Access to HACCP Records
publications Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products
Seafood HACCP Transition December Do.
Do. Policy
1999
Seafood List
1993
Do.
Do.
Fish and Fisheries Products 2001
Do.
Do. Hazards and Control Guide (3rd ed.)
HACCP Regulation for Fish 1998
Do.
Do. and Fishery Products: Questions and Answers
Implementation of Section December Do.
Do. 403(t) of the Federal Food, 2002 Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term ``Catfish''
Letter to Various Seafood February Do.
Do. Trade Associations
28, 2003 Regarding the Labeling of Catfish §§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§ WITHDRAWN GUIDANCES
[[Page 900]]
Guidance for Industry:
June 2000 N/A
N/A Fumonisin Levels in Human Foods and Animal Feeds, Draft (replaced by Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Final (November 2001)
Guidance for Industry
December Do.
Do. Qualified Health Claims in 2002 the Labeling of Conventional Foods and Dietary Supplements (replaced by Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements and Interim Evidence-Based Ranking System for Scientific Data (July 2003))
Guidance for Industry
June 2000 Do.
Do. Preparation of Premarket Notifications for Food Contact Substances: Administrative; Draft (replaced by Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Administrative; Final (May 2002))
Guidance for Industry
May 2000 Do.
Do. Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations, Draft (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Chemistry Recommendations; Final (April 2002))
Recommendations for
June 1995 Do.
Do. Chemistry Data for Indirect Food Additive Petitions (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Chemistry Recommendations; Final (April 2002))
Guidance for Industry
September Do.
Do. Preparation of Premarket 1999 Notifications for Food Contact Substances: Toxicology Recommendations (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations; Final (April 2002))
Iron-Containing Supplements November Do.
Do. and Drugs: Label Warning 1997 and Unit Dose Packaging Small Entity Compliance Guide (replaced by Guidance for Industry; Iron- Containing Supplements and Drugs: Label Warning Statements; Small Entity Compliance Guide (October 2003))
Guidance for Industry
July 2001 Do.
Do. Channels of Trade Policy for Commodities With Vinclozolin Residues; Draft (replaced by Guidance for Industry Channels of Trade Policy for Commodities With Vinclozolin Residues; Final (June 2002))
Guidance for Industry
November Do.
Do. Refusal of Inspection or 2000 Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Draft (replaced by Guidance for Industry Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Final (July 2001))
Guidance Document for
1993
Do.
Do. Arsenic
Guidance Document for
1993
Do.
Do. Cadmium
Guidance Document for
1993
Do.
Do. Chromium
Guidance Document for Lead 1993
Do.
Do.
Guidance Document for Nickel 1993
Do.
Do.
[[Page 901]]
Guidance Documents Issued by CVM
Intended User Date of
or
How to Obtain Name of Document
Issuance Regulatory a Copy of the Activity Document
159 Studies to November FDA personnel Internet via Evaluate the Safety of
12, 2003 and
http:// Residues of Veterinary
regulated www.fda.gov/
Drugs in Human Food:
industry cvm/guidance/ General Approach to
published.htm Establish a Microbiological
, or ADI (VICH GL36)
Communication s Staff (HFV- 12), FDA/CVM, 7519 Standish Pl., Rockville, MD, 301-827- 3800, FAX: 301-827-4065
158 Use of Material September Regulated Do. From Deer and Elk in Animal 15, 2003 industry Feed; Final
156 Comparability February Do.
Do. Protocols; Chemistry,
2003 Manufacturing, and Controls Information; Draft
153 Drugs,
September Do.
Do. Biologics, and Medical
2002 Devices Derived From Bioengineered Plants for Use in Humans and Animals; Draft
152 Evaluating the October 23, Do.
Do. Safety of Antimicrobial New 2003 Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern
151 FDA Export July 2004 Do.
Do. Certificates
150 Status of Clove June 11, Do.
Do. Oil and Eugenol for
2002 Anesthesia of Fish
149 Studies to May 18, Do.
Do. Evaluate the Safety of
2004 Residues of Veterinary Drugs in Human Food: General Approach to Testing (VICH GL33)
148 Studies to March 19, Do.
Do. Evaluate the Safety of
2004 Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (VICH GL32); Final Guidance
147 Studies to November Do.
Do. Evaluate the Safety of
12, 2003 Residues of Veterinary Drugs in Human Food; Repeat Dose (90-day) Toxicity Testing (VICH GL31)
145 Bioanalytical May 2001 Do.
Do. Method Validation
144 Pre-Approval April 27, Do.
Do. Information for
2004 Registration of New Veterinary Medicinal Products for Food-producing Animals with Respect to Antimicrobial Resistance (VICH GL27); Final Guidance
143
February 1, Do.
Do. Pharmacovigilance of
2002 Veterinary Medicinal Products: Controlled List of Terms (VICH GL30); Draft Guidance
142
December Do.
Do. Pharmacovigilance of
12, 2001 Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (VICH GL29); Draft Guidance
141 Studies to May 24, Do.
Do. Evaluate the Safety of
2004 Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (VICH GL28); Final Guidance
132 The
November 6, Do.
Do. Administrative New Animal 2002 Drug Application Process; Draft
126 BACPAC I:
February Do.
Do. Intermediates in Drug
2001 Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
124 Voluntary
January Do.
Do. Labeling Indicating Whether 2001 Foods Have or Have Not Been Developed Using Bioengineering; Draft
122 Manufacture and November 9, Do.
Do. Labeling of Raw Meat Foods 2004 for Companion and Captive Noncompanion Carnivores and Omnivores
[[Page 902]]
121 Expedited
March 6, Do.
Do. Review for New Animal Drug 2001 Applications for Human Pathogen Reduction Claims
120 Veterinary March 1, Do.
Do. Feed Directive Regulation 2001
119 How CVM
August 29, Do.
Do. Intends to Handle Deficient 2002 Submissions Filed During the Investigation of a New Animal Drug; Final Guidance
118 Mass
May 1, 2003 Do.
Do. Spectrometry for Confirmation of the Identity of Animal Drug Residues; Final Guidance
117
December Do.
Do. Pharmacovigilance of
12, 2000 Veterinary Medical Products: Management of Adverse Event Reports (AERs) (VICH GL24); Draft Guidance
116 Studies to January 3, Do.
Do. Evaluate the Safety of
2002 Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (VICH GL23); Final Guidance
115 Safety Studies January 3, Do.
Do. for Veterinary Drug
2002 Residues in Human Food; Reproduction Toxicity Testing (VICH GL22); Final Guidance
114 Effectiveness June 19, Do.
Do. of Anthelmintics: Specific 2002 Recommendations for Poultry- Gallus Gallus (VICH GL21); Final Guidance
113 Effectiveness June 19, Do.
Do. of Anthelmintics: Specific 2002 Recommendations for Feline (VICH GL20); Final Guidance
112 Fumonisin
November 9, Do.
Do. Levels in Human Foods and 2001 Animal Feeds; Final Guidance
111 Effectiveness June 27, Do.
Do. of Anthelmintics: Specific 2002 Recommendations for Canine (VICH GL19); Final Guidance
110 Effectiveness June 27, Do.
Do. of Anthelmintics: Specific 2002 Recommendations for Porcine (VICH GL16); Final Guidance
109 Effectiveness June 27, Do.
Do. of Anthelmintics: Specific 2002 Recommendations for Equine (VICH GL15); Final Guidance
108 How to Submit May 21, Do.
Do. Information in Electronic 2004 Format by E-mail
107 How to Submit a May 21, Do.
Do. Protocol in Electronic
2004 Format by E-mail
106 The Use of August 31, Do.
Do. Published Literature in 2000 Support of New Animal Drug Approval
105 Computerized September Do.
Do. Systems Used in Clinical 2004 Trials
104 Content and July 10, Do.
Do. Format of Effectiveness and 2001 Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Nonfood Animals
103 Possible Dioxin/ August 1999 Do.
Do. PCB Contamination of Drug and Biological Products
102 Manufacture and August 27, Do.
Do. Distribution of Unapproved 1999 Piperazine Products; Revised
100 Impurities: May 15, Do.
Do. Residual Solvents in New 2001 Veterinary Medicinal Products, Active Substances and Excipients (VICH GL18); Final Guidance
99 Stability
March 26, Do.
Do. Testing of New
2001 Biotechnological/Biological Veterinary Medicinal Products (VICH GL17); Final Guidance
[[Page 903]]
98 Dioxin in
April 14, Do.
Do. Anticaking Agents Used in 2000 Animal Feed and Feed Ingredients; Revised
97 Effectiveness of March 26, Do.
Do. Anthelmintics: Specific 2001 Recommendations for Caprine (VICH GL14); Final Guidance
96 Effectiveness of March 26, Do.
Do. Anthelmintics: Specific 2001 Recommendations for Ovine (VICH GL13); Final Guidance
95 Efficacy of March 26, Do.
Do. Anthelmintics: Specific 2001 Recommendations for Bovines; (VICH GL12); Final Guidance
93 Impurities in May 1, 2000 Do.
Do. New Veterinary Medical Products (VICH GL11)
92 Impurities in May 1, 2000 Do.
Do. New Veterinary Drug Substances (VICH GL10)
91 Stability
March 2000 Do.
Do. Testing for Medicated Premixes (VICH GL8); Final Guidance
90 Effectiveness of October 11, Do.
Do. Anthelmintics: General
2001 Recommendations (VICH GL7); Final Guidance (replaces March 26, 2001)
89 Environmental March 7, Do.
Do. Impact Assessments (EIAs) 2001 for Veterinary Medicinal Products (VMPs)--Phase I (VICH GL6); Final Guidance
88 How to Submit a May 21, Do.
Do. Request for a Meeting or 2004 Teleconference in Electronic Format by E-mail
87 How to Submit a May 21, Do.
Do. Notice of Intent to
2004 Slaughter for Human Food Purposes in Electronic Format by E-mail
86 How to Submit a May 21, Do.
Do. Notice of Final Disposition 2004 of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format by E-mail
85 Good Clinical May 9, 2001 Do.
Do. Practice (VICH GL9); Final Guidance
84 Product Name January Do.
Do. Placement, Size and
1999 Prominence in Advertising and Promotional Labeling; Draft Guidance
83 Chemistry,
June 1999 Do.
Do. Manufacturing, and Controls Changes to an Approved NADA or ANADA; Draft Guidance
82 Development of October 28, Do.
Do. Supplemental Applications 2002 for Approved New Animal Drugs; Final Guidance
80 Studies to
November Do.
Do. Evaluate the Utility of 21, 2002 Anti-Salmonella Chemical Food Additives in Feeds
79 Dispute
May 16, Do.
Do. Resolution Procedures for 2003 Science-Based Decisions on Products Regulated by CVM; Draft Guidance
78 Consideration of December Do.
Do. the Human Health Impact of 13, 1999 the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals
76 Questions and July 1998 Do.
Do. Answers: BSE Feed Regulation
75 Stability
September Do.
Do. Testing: Photostability 1999 Testing of New Veterinary Drug Substances and Medicinal Products; Final Guidance
74 Stability
September Do.
Do. Testing of New Veterinary 1999 Dosage Forms (VICH GL4); Final Guidance
73 Stability
September Do.
Do. Testing of New Veterinary 1999 Drug Substances and Medicinal Products (VICH GL3); Final Guidance
[[Page 904]]
72 GMPs for
May 1998 Do.
Do. Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDA
70 Para
February Do.
Do. Alimentadores de Animales 1998 Rumiantes Sin Operaciones de Mezclado de Alimentos en la Granja
70 Small Entities February Do.
Do. Compliance Guide for
1998 Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations
69 Para
February Do.
Do. Alimentadores de Animales 1998 Rumiantes Con Operaciones de Mezclado de Alimentos en la Granja
69 Small Entities February Do.
Do. Compliance Guide for
1998 Feeders of Ruminant Animals With On-Farm Feed Mixing Operations
68 Para Mezcladores February Do.
Do. de Prote[Iacute]nas,
1999 Fabricantes de Alimentos para Animales y Distribuidores
68 Small Entities February Do.
Do. Compliance Guide for
1998 Protein Blenders, Feed Manufacturers, and Distributors
67 Para Extractores February Do.
Do. de Grasa por Fusion
1998
67 Small Entities February Do.
Do. Compliance Guide for
1998 Renderers
65 Industry-
November Do.
Do. Supported Scientific and 1997 Educational Activities
64 Validation of July 1999 Do.
Do. Analytical Procedures: Methodology; Final Guidance
63 Validation of July 1999 Do.
Do. Analytical Procedures: Definition and Terminology
62 Consumer-
August 1999 Do.
Do. Directed Broadcast Advertisements; Final Guidance
61 FDA Approval of April 1999 Do.
Do. New Animal Drugs for Minor Uses and for Minor Species
59 How to Submit a May 21, Do.
Do. Notice of Claimed
2004 Investigational Exemption in Electronic Format by E- mail
57 Guidance for 1995
Do.
Do. Industry for the Preparation and Submission of Veterinary Master Files
56 Protocol
July 10, Do.
Do. Development Guideline for 2001 Clinical Effectiveness and Target Animal Safety Trials
55 Supportive Data June 1994 Do.
Do. for Cat Food Labels Bearing ``Reduces Urinary pH'' Claims: Guideline in Protocol Development
54 Draft Guideline June 22, Do.
Do. for Utility Studies for 1994 Anti-Salmonella Chemical Food Additives in Animal Feeds (see final guidance 80)
53 Guideline for May 1994 Do.
Do. the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic Animals
52 Assessment of February Do.
Do. the Effects of
18, 2004 Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal Flora
50 Draft Guideline February 1, Do.
Do. for Target Animal and Human 1993 Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic Products
49 Guidance
April 4, Do.
Do. Document for Target Animal 1996 Safety and Drug Effectiveness Studies for Antimicrobial Bovine Mastitis Products (Lactating and Nonlactating Cow Products)
[[Page 905]]
48 Guidance for November Do.
Do. Industry for the Submission 1994 Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
45 Guideline for August 1993 Do.
Do. Uniform Labeling of Drugs for Dairy and Beef Cattle
43 Guidance on October Do.
Do. Generic Animal Drug
1995 Products Containing Fermentation-Derived Drug Substances
42 Animal Drug 1994
Do.
Do. Manufacturing Guidelines
41 Draft Guideline June 1992 Do.
Do. for Formatting, Assembling, and Submitting New Animal Drug Applications
40 Draft Guideline April 1992 Do.
Do. for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry
38 Guideline for August 21, Do.
Do. Effectiveness Evaluation of 1984 Topical/OTIC Animal Drugs
37 Guidelines for March 1984 Do.
Do. Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feeds for Pigmentation
36 Guideline for July 18, Do.
Do. Efficacy Evaluation of
1985 Canine/Feline Anthelmintics
35 Bioequivalence Revised Do.
Do. Guideline
October 9, 2002
33 Target Animal June 1989 Do.
Do. Safety Guidelines for New Animal Drugs
31 Guidelines for July 1981 Do.
Do. the Evaluation of Bovine Anthelmintics
29 Guidelines for September Do.
Do. the Effectiveness
30, 1980 Evaluation of Swine Anthelmintics
28 Animal Drug December 3, Do.
Do. Applications Expedited
1997 Review Guideline (see Policy and Procedures Guide 1240.3135)
27 New Animal Drug July 1989 Do.
Do. Determination (see Policy and Procedures Guide 1240.3500)
24 Guideline for October Do.
Do. Drug Combinations for Use 1983 in Animals
23 Medicated Free- July 1, Do.
Do. Choice Feeds-Manufacturing 1985 Controls
22 Labeling of ........... Do.
Do. Arecoline Base Drugs Intended for Animal Use
21 Nutritional March 1993 Do.
Do. Ingredients in Animal Drugs and Feeds (see Policy and Procedures Guide 1240.3420)
16 Freedom of
May 10, Do.
Do. Information Summary
1985 Guidelines
13 Guidelines for January Do.
Do. Evaluation and
1985 Effectiveness of New Animal Drugs for Use in Free- Choice Feeds (revision of The Cattle Medicated Block Guideline)
10 Amendment of October Do.
Do. Section II(G)(1)(b)(4) of 1975 the Preclearance Guidelines
9 Preclearance Withdrawn Do.
Do. Guidelines for Production pending Drugs
revisions
6 Guideline for October 20, Do.
Do. Submitting NADAs for
1971; Generic Drugs Reviewed by revised NAS/NRC
March 19, 1976
5 Drug Stability December 1, Do.
Do. Guidelines
1990
[[Page 906]]
3 General
July 1994 Do.
Do. Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (revised) (see guidance 118 for update to Section V.B.1) §§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§§ WITHDRAWN DOCUMENTS
58 Guidance for May 1997 N/A
N/A Industry; Good Target Animal Study Practices: Clinical Investigators and Monitors
155 Guidance for March 1997/ Do.
Do. Industry; 21 CFR Part 11; February Electronic Records;
2003 Electronic Signatures, Electronic Copies of Electronic Records
154 Draft Guidance March 1997/ Do.
Do. for Industry on Part 11; February Electronic Records,
2003 Electronic Signatures-- Scope and Application
77 Interpretation September Do.
Do. of On-Farm Feed
1998/June Manufacturing and Mixing 2003 Operations
66 Professional August 1998/ Do.
Do. Flexible Labeling of
January Antimicrobial Drugs
2002 20 Antibacterial December Do.
Do. Drugs in Animal Feeds:
2004 Antibacterial Effectiveness Criteria
19 Antibacterial December Do.
Do. Drugs in Animal Feeds:
2004 Animal Health Safety Criteria
18 Antibacterial December Do.
Do. Drugs in Animal Feeds:
2004 Human Health Safety Criteria
15 Guideline for February Do.
Do. Reporting the Details of 1977/ Clinical Trials Using an December Investigational New Animal 2004 Drug in Non-Food Producing Animals
14 Guideline for December Do.
Do. Reporting the Details of 2004 Clinical Trials Using an Investigational New Animal Drug in Food-Producing Animals
4 Guideline for December Do.
Do. Efficacy Studies for
2004 Systemic Sustained Release Sulfonamide Boluses for Cattle
2 Anthelmintics December Do.
Do. 2004
Guidance Documents Issued by the Office of the Commissioner and the Office of Policy
Intended Date of User or How to Obtain a Copy Name of Document
Issuance Regulatory of the Document Activity
FDA Information Sheets for September Regulated Internet via http:// Institutional Review
1998 industry www.fda.gov/oc/ohrt/
Boards and Clinical
irbs/default.htm or Investigators
Good Clinical Practice Programs (HF-34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C-24, Rockville, MD 20857, 301-827- 3340, http://www.fda.gov/oc/gcp/ for Industry; April Do.
Internet via http://
Computerized Systems Used 1999
http://www.fda.gov/ora/ in Clinical Trials
compliance--ref/
bimo/ffinalcct.pdf or Good Clinical Practice Programs (HF-34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C-24, Rockville, MD 20857, 301-827- 3340, http://www.fda.gov/oc/gcp/ Guidance for
March 30, Do.
Internet via http://
Institutional Review
2000
http://www.fda.gov/ora/ Boards, Clinical
compliance--ref/
Investigators, and
bimo/err--guide.htm Sponsors: Exceptions From
or Good Clinical Informed Consent
Practice Programs Requirements for
(HF-34), Food and Emergency Research
Drug Administration, 5600 Fishers Lane, rm. 9C-24, Rockville, MD 20857, 301-827-3340
[[Page 907]]
Draft Guidance for
February Do.
Internet via http:// Industry on Exports and 1998
www.fda.gov/opacom/
Imports Under the FDA
fedregister/ Export Reform and
frexport.html Enhancement Act of 1996
Guidance for FDA and
November FDA
Internet via http:// Industry: Direct Final 21, 1997 personnel www.fda.gov/opacom/
Rule Procedures
morechoices/ industry/ guidance.htm, or Office of Policy, 301-827-3360
International
October Regulated 60 FR 53078, October Harmonization; Policy on 11, 1995 industry 11, 1995; or Office Standards
and FDA of International personnel Programs, 301-827- 4480
Guidance Documents Issued by ORA
Intended User or How to Obtain a Copy of the Document Name of Document
Date of Issuance Regulatory --------------------------------------------- Activity
Mailing Address
Internet Address
Compliance Policy Guides Updated December FDA staff
National Technical http://www.fda.gov/ora/ Manual (replaces Compliance 12, 2003
Information
cpgm
Policy Guide--January 1996)
Service, 5285 Port Royal Rd., Springfield, VA 22161
Compliance Policy Guide, April 2001
Do.
Division of
http://www.fda.gov/ora/ Section 615.115: Extra-
Compliance Policy compliance--ref/
Label Use of Medicated
(HFC-230), Office revisions.htm Feeds for Minor Species
of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0420
Compliance Policy Guide, July 2003
Do.
Do.
Do. Section 608.400: Compounding of Drugs for Use in Animals
Compliance Policy Guide, November 14, Do.
Do.
Do. Section 555.600: Filth From 2002 Insects, Rodents, and Other Pests in Foods
Compliance Policy Guide, May 29, 2002 Do.
Do.
Do. Section 460.200: Pharmacy Compounding
Compliance Policy Guide, May 16, 2002 Do.
Do.
Do. Section 575.100: Pesticide Residues in Food and Feed-- Enforcement Criteria (CPG 7141.01) (revised)
Compliance Policy Guide, May 7, 2002 Do.
Do.
Do. Section 230.150: Blood Donor Classification Statement, Paid or Volunteer Donor
Compliance Policy Guide, October 2001 Do.
Do.
Do. Section 510.150: Apple Juice, Apple Juice Concentrates, and Apple Juice Products-- Adulteration With Patulin
Compliance Policy Guide, April 2001
Do.
Do.
Do. Section 555.250: Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens
Compliance Policy Guide, Reformatted Do.
Do.
http://www.fda.gov/ora/ Section 220.100: Interstate March 2001
compliance--ref/cpg/
Shipment of Biological Products for Use in Medical Emergencies
[[Page 908]]
Compliance Policy Guide, Reformatted Do.
Do.
Do. Section 270.100: Final
March 2001 Container Labels-- Allergenic Extracts Containing Glycerin; Reporting Changes
Compliance Policy Guide, December 2000 Do.
Do.
Do. Section 230.150: Blood Donor Incentives; Draft
Compliance Policy Guide, July 1991
FDA staff and Do.
http://www.fda.gov/ora/ Section 7150.09: Fraud,
regulated
compliance--ref/cpg/
Untrue Statements of
industry
cpggenl/cpg120- Material Facts, Bribery,
100.html and Illegal Gratuities
Glossary of Computerized August 1995 Do.
National Technical http://www.fda.gov/ora/ System and Software
Information
inspect--ref/igs/
Development Terminology
Service, 5285 Port gloss.html Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-127352)
Guidelines for Entry Review March 12, 1999 FDA staff
Division of Import N/A of Radiation-Emitting
Operations and Electronic Devices
Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594- 1218
Laboratory Procedures Manual June 1994
Do.
Division of Field http://www.fda.gov/ora/ Science (HFC-141), science--ref/
Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857
Laboratory Procedures
May 1999
Do.
Do.
Do. Manual; ch. 10: Method Validation Samples
Memorandum: ORA
May 15, 2000 Do.
Division of Field N/A Investigational Strategy on
Investigations, Gamma-Butyrolactone (GBL)
Office of Regional and Related Products
Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
IOM: Investigations
March 2004
Do.
National Technical http://www.fda.gov/ora/ Operations Manual
Information
inspect--ref/
Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001-913399)
Regulatory Procedures Manual March 2004
Do.
Do (NTIS Order No. http://www.fda.gov/ora/ PB97-196182)
compliance--ref/rpm/
default.htm
Regulatory Procedures
March 2004
Do.
Division of
Do. Manual; ch. 5-7-10: Civil
Compliance Policy Money Penalty Reduction
(HFC-230), Office Policy for Small Entities
of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0420
Regulatory Procedures
March 2004
Do.
Do.
Do. Manual; ch. 10-9: Application Integrity Policy
[[Page 909]]
Regulatory Procedures
September 2002 Do.
Do.
Do. Manual; ch. 9: Import Operations/Actions
Regulatory Procedures
March 2004
Do.
Do.
Do. Manual; ch. 6-1: Seizure
Regulatory Procedures
March 2004
Do.
Do.
Do. Manual; ch. 6-6: Civil Penalties--Electronic Product Radiation Control
Regulatory Procedures
March 2004
Do.
Do.
http://www.fda.gov/ora/ Manual; ch. 4-1: Warning
compliance--ref/rpm--
Letters
new2/ch4.html
Guide to Inspections of Bulk May 1994
Do.
National Technical http://www.fda.gov/ora/ Pharmaceutical Chemicals
Information
inspect--ref/igs/
Service, 5285 Port iglist.html Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-127154)
Guide to Inspections of July 1993
Do.
Do (NTIS Order No. Do. Pharmaceutical Quality
PB96-127279) Control Laboratories
Guide to Inspections of July 1993
Do.
Do (NTIS Order No. Do. Microbiological
PB96-127287) Pharmaceutical Quality Control Laboratories
Guide to Inspections of July 1993
Do.
Do (NTIS Order No. Do. Validation of Cleaning
PB96-127246) Processes
Guide to Inspections of July 1993
Do.
Do (NTIS Order No. Do. Lyophilization of
PB96-127253) Parenterals
Guide to Inspections of High July 1993
Do.
Do (NTIS Order No. Do. Purity Water Systems
PB96-127261)
Guide to Inspections of October 1993 Do.
Do (NTIS Order No. Do. Dosage Form Drug
PB96-127212) Manufacturers--CGMPs
Guide to Inspections of Oral January 1994 Do.
Do (NTIS Order No. Do. Solid Dosage Forms Pre/Post
PB96-127345) Approval Issues for Development and Validation
Guide to Inspections of July 1994
Do.
Do (NTIS Order No. Do. Topical Drug Products
PB96-127394)
Guide to Inspections of July 1994
Do.
Do (NTIS Order No. Do. Sterile Drug Substance
PB96-127295) Manufacturers
Guide to Inspections of Oral August 1994 Do.
Do (NTIS Order No. Do. Solutions and Suspensions
PB96-127147)
Guide to Nutritional
February 1995 Do.
Do (NTIS Order No. Do. Labeling and Education Act
PB96-127378) (NLEA) Requirements
Guide to Inspections of April 1995
Do.
Do (NTIS Order No. Do. Interstate Carriers and
PB96-127386) Support Facilities
Guide to Inspections of April 1995
Do.
Do (NTIS Order No. Do. Dairy Product Manufacturers
PB96-127329)
Guide to Inspections of May 1995
Do.
Do (NTIS Order No. Do. Manufacturers of
PB97-127220) Miscellaneous Foods--vol. 1
Guide to Inspections of September 1996 Do.
Do (NTIS Order No. Do. Manufacturers of
PB97-196133) Miscellaneous Food Products--vol. 2
[[Page 910]]
Guide to Inspections of February 1995 Do.
Do (NTIS Order No. Do. Cosmetic Product
PB96-127238) Manufacturers
Guide to Inspections of Low November 1996 Do.
Do (NTIS Order No. Do. Acid Canned Food
PB97-196141) Manufacturers, Part 1-- Administrative Procedures/ Scheduled Processes
Guide to Inspections of Low April 1997
Do.
Do (NTIS Order No. Do. Acid Canned Food
PB97-196158) Manufacturers, Part 2-- Manufacturing Processes/ Procedures
Guide to Inspections of Low November 1998 FDA staff
Do (NTIS Order No. N/A Acid Canned Food
PB00-133795) Manufacturers, Part 3-- Container/Closures
Guide to Inspections of September 1994 Do.
Do (NTIS Order No. http://www.fda.gov/ora/ Blood Banks
PB96-127303)
inspect--ref/igs/
iglist.html
Guide to Inspections of Revised April Do.
N/A
Do. Source Plasma
2001 Establishments
Guide to Inspections of October 1996 Do.
National Technical Do. Infectious Disease Marker
Information Testing Facilities
Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-199476)
Biotechnology Inspection November 1991 Do.
Do (NTIS Order No. Do. Guide Reference Materials
PB96-127402) and Training Aids
Guide to Inspection of
February 1983 Do.
Do (NTIS Order No. Do. Computerized Systems in
PB96-127337) Drug Processing
Guide to Inspections of September 1995 Do.
Do (NTIS Order No. Do. Foreign Medical Device
PB96-127311) Manufacturers
Guide to Inspections of May 1996
Do.
Do (NTIS Order No. Do. Foreign Pharmaceutical
PB96-199468) Manufacturers
Guide to Inspections of December 1997 Do.
Do (NTIS Order No. Do. Medical Device
PB 98-127145 ) Manufacturers
Mammography Quality
January 1998 Do.
Do (NTIS Order No. Do. Standards Act (MQSA)
PB98-127178) Auditor's Guide
Guide to Inspections of December 1997 Do.
Do (NTIS Order No. Do. Electromagnetic
PB98-127152) Compatibility Aspects of Medical Device Quality Systems
Guide to Inspections of May 1998
Do.
N/A
Do. Acidified Food Manufacturers
Guide to Inspection of
February 2001 Do.
Division of Field N/A Aseptic Processing and
Investigations, Packaging for the Food
Office of Regional Industry
Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
Guide to Inspections of July 2003
Do.
Do (NTIS Order No. Do. Grain Product Manufacturers
PB98-137128)
Guide to Bioresearch
February 1998 Do.
Do (NTIS Order No. Do. Monitoring Inspections of
PB98-137151) In Vitro Diagnostic Devices
Guide to Inspections of March 1998
Do.
Do (NTIS Order No. Do. Viral Clearance Processes
PB-98137144) for Plasma Derivatives
[[Page 911]]
Guide to Traceback of Fresh April 2001
Do.
N/A
Do. Fruits and Vegetables Implicated in Epidemiological Investigations
Guide to Inspections of August 1998 Do.
National Technical Do. Computerized Systems in the
Information Food Processing Industry
Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB98-137136)
Guide to International
November 2002 Do.
N/A
http://www.fda.gov/ora/ Inspections and Travel
inspect--ref/giit/
(revision) (formerly FDA/
default.htm ORA International Inspection Manual and Travel Guide)
Guide to Inspections of August 1999 Do.
N/A
http://www.fda.gov/ora/ Quality Systems
inspect--ref/igs/qsit/
QSITGUIDE.PDF
Guide to Inspection of Firms August 2001 Do.
N/A
http://www.fda.gov/ora/ Producing Food Products
inspect--ref/igs/
Susceptible to
iglist.html Contamination With Allergenic Ingredients
Computerized Systems Used in April 1999
Do.
N/A
http://www.fda.gov/ora/ Clinical Trials
compliance--ref/bimo/
Compliance Program 7348.001: October 1, 1999 Do.
Division of
Do. Bioresearch Monitoring,
Compliance Policy Human Drugs, In Vivo
(HFC-230), Office Bioequivalence
of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0420
Guide for Detecting Fraud in April 2003
Do.
Division of Freedom N/A Bioresearch Monitoring
of Information Inspections
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
Good Laboratory Practice October 1, 2000 Do.
Division of
http://www.fda.gov/ora/ Program 7348.808A
Compliance Policy compliance--ref/bimo/
(Nonclinical Laboratories);
(HFC-230), Office EPA Data Audit Inspections
of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0420
Guideline for the Monitoring January 1988 FDA regulated Do.
Do. of Clinical Investigations
industry
Small Business Guide to FDA Revised March Do.
Federal-State
http://www.fda.gov/ora/ 31, 2004
Relations (HFC- fed--state/small--
150), Office of business/sb--guide/ Regulatory
default.htm Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 2905
Compliance Program 7348.808; Revised February FDA staff
Division of
http://www.fda.gov/ora/ Bioresearch Monitoring, 21, 2001
Compliance Policy compliance--ref/bimo/
Good Laboratory Practice
(HFC-230), Office (Nonclinical Laboratories)
of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0420
[[Page 912]]
Compliance Program 7348.809; October 1, 1994 Do.
Do.
Do. Bioresearch Monitoring; Institutional Review Board
Compliance Program 7348.811; October 1, 1997 Do.
Do.
Do. Bioresearch Monitoring, Clinical Investigators
Good Laboratory Practice August 1979 Do.
Do.
Do. Regulations; Management Briefings; Post Conference Report
Good Laboratory Practices; June 1981
Do.
Do.
Do. Questions and Answers
Guidance for FDA Staff on April 4, 2003 FDA staff
N/A
http://www.fda.gov/ Sampling or Detention
ohrms/dockets/98fr/03-
Without Physical
8315.pdf Examination of Decorative Contact Lenses (Import Alert 86-10)
Compliance Policy Guide; March 29, 2002 FDA staff and Division of
http://www.fda.gov/ora/ Section 345.100: Male
industry
Compliance Policy compliance--ref/cpg/
Condom Defects (CPG
(HFC-230), Office 7124.21); Draft
of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0420
PTC for Internal Reviews and June 1991
Do.
N/A
http://www.fda.gov/ora/ Corrective Action Operating
compliance--ref/aip--
Plans
points.html
WITHDRAWALS
Compliance Policy Guide-- June 15, 1976 FDA staff and
N/A Section 305.100:
industry Acupuncture Devices and Accessories (CPG 7124.11)
Compliance Policy Guide-- October 1, 1980 Do.
Do. Section 396.100: Applicability of the Sunlamp Performance Standard to UVA Tanning Products (CPG 7133.16)
Compliance Policy Guide-- October 1, 1980 Do.
Do. Section 391.100: Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13)
Compliance Policy Guide-- April 26, 1976 Do.
Do. Section 315.200: Status of Dental Supplies Such As Denture Cleaners, Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG 7124.05)
Compliance Policy Guide-- October 1, 1980 Do.
Do. Section 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)
Medical Device Warning
March 8, 1999 Do.
Do. Letter Pilot Termination
Compliance Policy Guide-- May 13, 1999 Do.
Do. Section 160.850: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17)
Draft Guidance--21 CFR Part August 2002 Do.
Do. 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
[[Page 913]]
Draft Guidance--21 CFR Part August 2001 Do.
Do. 11; Electronic Records; Electronic Signatures Validation
Draft Guidance--21 CFR Part August 2001 Do.
Do. 11; Electronic Records; Electronic Signatures, Glossary of Terms
Draft Guidance--21 CFR Part February 2002 Do.
Do. 11; Electronic Records; Electronic Signatures, Time Stamps
Draft Guidance--21 CFR Part July 2002
Do.
Do. 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records
Compliance Policy Guide-- February 26, Do.
Do. Section 300.700: Direct 1991 Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (CPG 7124.30)
Compliance Policy Guide-- October 1, 1980 Do.
Do. Section 405.100: Prescriptions Prepared From Certified Antibiotics (CPG 7122.01)
Compliance Policy Guide-- October 1, 1980 Do.
Do. Section 405.200: Export of Uncertified Antibiotics (CPG 7122.02)
Compliance Policy Guide-- July 1, 1981 Do.
Do. Section 405.210: Returned Antibiotics Exported Under 801(d) of the Act (CPG 7122.03)
Draft Compliance Policy August 28, 1997 Do.
Do. Guide--Distributor Medical Device Reporting
Dated: December 22, 2004. Jeffrey Shuren, Assistant Commissioner for Policy.
[FR Doc. 05-155 Filed 1-4-05; 8:45 am]
BILLING CODE 4160-01-S
