Document ID: FDA-1998-N-0050-0007
Agency: fda
Document Type: Notice
Title: Comprehensive List of Guidance Documents at Food and Drug Administration; Notice
Posted Date: 2010-08-09T04:00Z

[Federal Register: August 9, 2010 (Volume 75, Number 152)]
[Notices]               
[Page 48179-48233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au10-122]                         

[[Page 48179]]

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Part III

Department of Health and Human Services

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Food and Drug Administration

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Comprehensive List of Guidance Documents at the Food and Drug 
Administration; Notice

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-N-0050] (formerly Docket No. 1998N-0046)

 
Comprehensive List of Guidance Documents at the Food and Drug 
Administration

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is publishing a 
comprehensive list of all guidance documents currently in use at the 
agency. This list is being published under FDA's Good Guidance 
Practices (GGPs). 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withdrawn in the past 5 years.

DATES:  We welcome general comments on this list and on agency guidance 
documents at any time.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    For information on a specific guidance or to obtain a paper copy, 
please refer to each Center's section of this document.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's GGPs were published in the Federal Register of September 19, 
2000 (65 FR 56468), and became effective October 19, 2000. GGPs (21 CFR 
10.115) are intended to ensure involvement of the public in the 
development of guidance documents, and to enhance understanding of the 
availability, nature, and legal effect of such guidance.
    FDA has adopted a new format for the publication of its 
comprehensive guidance list. This new format is intended to increase 
the timeliness of the comprehensive list. For information on a specific 
guidance or to obtain a paper copy, please refer to each Center's 
section of this document. The lists of guidance documents are either a 
printout of FDA's Web site as of April 2010 or a list compiled by the 
issuing office. You should note that some guidance documents pertain to 
more than one product area (e.g., drugs and biologics), and are, 
therefore, listed under both Centers involved or pertain to more than 
one subject matter (e.g., ``Food Defense and Emergency Response'' and 
``Imports''), and are, therefore, listed under more than one category 
within a Center. So there may be some duplication in the guidance 
lists. You are encouraged to use FDA's Web site as the most up-to-date 
source for all current guidance documents in use by the agency, as the 
Web site is updated on a daily basis.
    In accordance with the agency's general policy on guidances, you 
may comment on this list and on any FDA guidance document at any time.
    We have organized the guidance documents by the issuing Center or 
Office within FDA. The dates in the list refer to the date we issued 
the guidances or, where applicable, the last date we revised a 
document. Because each issuing Center or Office maintains its own 
database, there are slight variations in the way in which they provide 
the information.

II. Center for Biologics Evaluation and Research (CBER)

    For information a specific guidance document or to obtain a paper 
copy, contact:
    Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-
1800, e-mail: ocod@fda.hhs.gov, http://www.fda.gov/
BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm.
    The following is a list of CBER guidance documents that have been 
withdrawn:

------------------------------------------------------------------------
                                              Date of         Date of
            Title of Document                 Issuance      Withdrawal
------------------------------------------------------------------------
Guidance for Industry: Gamma Irradiation   3/15/2000      4/10/2006
 of Blood and Blood Components: A Pilot
 Program for Licensing
------------------------------------------------------------------------
Draft Guidance for Industry: CBER Pilot    7/11/2001      4/11/2006
 Licensing Program for Immunization of
 Source Plasma Donors Using Immunogen Red
 Blood Cells Obtained from an Outside
 Supplier
------------------------------------------------------------------------
Draft Guidance for Industry: Submitting    8/23/2001      August 9,
 Type V Drug Master Files to the Center                    2010.
 for Biologics Evaluation and Research
------------------------------------------------------------------------

    The following list of current CBER guidance documents was obtained 
from FDA's Web site on April 20, 2010:

Administrative
   Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments,
   and Proposed REMS Modifications (PDF - 316KB)
   9/2009
   Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)
   5/2009
   Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific
   Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
   1/2009
   Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of
   the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section
   228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
   9/15/2005

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   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria
   10/4/2004
   Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions
   (510(k)s)
   5/28/2004
   FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock
   and Performance Assessment
   5/21/2004
   Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
   11/24/2003
   Premarket Approval Application Modular Review
   11/3/2003
Adverse Events and Product Deviation Guidances
   Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
   Human Subject Protection (PDF - 61KB)
   1/2009
   Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an
   Influenza Pandemic (PDF - 246KB)
   12/2008
   Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
   (PDF - 107KB)
   6/2008
   Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of
   Biological Products Other than Blood and Blood Components
   10/2006
   Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
   and Format (PDF - 52KB)
   1/2006
   Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF -
   375KB)
   3/2001
   Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products:
   Clarification of What to Report (PDF - 95KB)
   8/1997
Allergenic Guidance Documents
   Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
   11/20/2008
   Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
   Revised Protocol
   11/20/2000
   Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information
   and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
   4/23/1999
Application Submissions
   Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
   2/2010
   SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
   10/2009
   Investigator Responsibilities--Protecting the Rights, Safety, and Welfare of Study Subjects (PDF -
   163KB)
   10/2009
   Providing Regulatory Submissions in Electronic Format--(PDF - 123KB)
   5/2009
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   12/2008
   Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
   11/2008
   Tropical Disease Priority Review Vouchers (PDF - 112KB)
   10/2008
   Integrated Summary of Effectiveness (PDF - 95KB)
   8/2008
   Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA
   Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 121KB)
   8/2008
   Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
   (PDF - 107KB)
   6/2008
   Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and
   Related Submissions Using the eCTD Specifications (PDF - 133KB)
   6/2008
   Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
   (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
   6/2008
   Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
   Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
   2/2008
   Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
   Version) (PDF - 127KB)
   2/2008
   Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and
   Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
   11/2007

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   In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
   10/2007
   Pharmacogenomic Data Submissions--Companion Guidance (PDF - 211KB)
   8/2007
   Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
   Submission (PDF Version) (PDF - 145KB)
   6/2007
   Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59KB)
   6/2007
   Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
   Applications (PMA) (PDF Version) (PDF - 127KB)
   10/2006
   Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
   Version) (PDF - 82KB)
   4/2006
   Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
   and Drug Administration Modernization Act of 1997 (PDF - 456KB)
   2/2006
   Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
   - 295KB)
   2/2006
   Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
   110KB)
   2/2006
   Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
   2/2006
   How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
   9/2005
   Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
   5/2005
   Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
   Contained in Medical Devices (PDF version) (PDF - 342KB)
   5/2005
   Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
   4/2005
   Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
   4/2005
   Pharmacogenomic Data Submissions (PDF - 96KB)
   3/2005
   Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
   - 211KB)
   12/2004
   Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
   Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
   11/2004
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
   10/2004
   Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
   (510(k)s) (PDF Version) (PDF - 109KB)
   5/2004
   Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
   Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
   5/2004
   Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF
   Version) (PDF - 87KB)
   11/2003
   Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
   - 159KB)
   11/2003
   Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
   10/2003
   Part 11, Electronic Records; Electronic Signatures--Scope and Application (PDF - 215KB)
   8/2003
   Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
    529KB)
   5/2003
   Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
   2/2003
   Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
   2/2003
   Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
   Staff - PDF (PDF - 548KB)
   2/2003
   Special Protocol Assessment (PDF - 36KB)
   5/2002
   Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational
   New Drug Applications (INDs) (PDF) (PDF - 80KB)
   3/2002
   Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
   10/2001
   Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics
   Evaluation and Research
   9/2001

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   Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF -
   50KB)
   8/2001
   Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF -
   32KB)
   4/2001
   Acceptance of Foreign Clinical Studies (PDF - 12KB)
   3/2001
   Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
   11/2000
   Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
   10/2000
   Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
   Biotechnology-Derived Products (PDF - 14KB)
   10/2000
   Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)
   2/2000
   Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
   2/2000
   Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
   (PDF - 57KB)
   9/1999
   Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
   8/1999
   Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in
   Electronic Format - Biologics Marketing Applications (PDF - 582KB)
   11/1999
   Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory
   Committees (PDF - 62KB)
   10/1998
   Submitting Debarment Certification Statements (PDF - 144KB)
   9/1998
   Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)
   5/1998
   Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
   4/1998
   Pediatric Use Supplements--Content and Format (PDF - 24KB)
   5/1996
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF
    41KB)
   11/1995
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
   Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
   11/1995
   FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and
   Manufacture of Biological Products; Availability (PDF - 34KB)
   7/1995
   Submission Documentation for Sterilization Process Validation in Applications for Human and
   Veterinary Drug Products (PDF - 57KB)
   11/1994
   Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
   3/1991
   Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance
   with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration
   Amendments Act of 2007
Blood Guidance Documents
   Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood
   Components, October 2009 (PDF - 858KB)
   10/2009, Updated: 12/2009
   Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood
   Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 80KB)
   11/13/2009
   Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
   Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (PDF - 68KB)
   11/6/2009
   Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
   Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
   Reconstitution for Specified Indications (PDF - 91KB)
   10/2009
   Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
   Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
   10/2009
   Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human
   Immunodeficiency Virus Type 1 (HIV-1) Group O Infection
   8/2009
   Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19
   Transmission by Plasma-Derived Products
   7/28/2009
   Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
   Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
   Cellular and Tissue-Based Products
   3/2009
   Assay Migration Studies for In Vitro Diagnostic Devices
   1/5/2009

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   Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
   Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
   7/17/2008
   Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of
   Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
   5/20/2008
   Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
   Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
   Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   4/25/2008
   Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
   12/17/2007
   Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood
   Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
   11/29/2007
   Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B
   Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source
   Plasma and Source Leukocytes
   11/21/2007
   Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
   10/26/2007
   Guidance for Industry: ``Lookback'' for Hepatitis C Virus (HCV): Product Quarantine, Consignee
   Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor
   Test Results Indicating Infection with HCV
   8/24/2007
   Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance
   Genotype Assay
   8/08/2007
   Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in
   Plasmapheresis and Immunization Programs
   6/20/2007
   Draft Guidance for Industry: ``Computer Crossmatch'' (Electronic Based Testing for the Compatibility
   between the Donor's Cell Type and the Recipient's Serum or Plasma Type)
   6/20/2007
   Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and
   Accompanying Materials for Use in Screening Donors of Blood and Blood Components
   10/27/2006
   Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
   10/18/2006
   Guidance for Industry: Bar Code Label Requirements - Questions and Answers
   10/5/2006
   Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component
   Container Labels
   9/22/2006
   United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components
   Using ISBT 128 (PDF - 1665KB)
   9/22/2006
   Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-
   Associated and Other Immunoglobulin (IgG) Antibodies
   8/08/2006
   Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to
   ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
   Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''
   8/08/2006
   Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-
   1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
   7/19/2005
   Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of
   Known or Suspected West Nile Virus Infection
   6/23/2005
   Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
   Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
   Based Products (HCT[sol]Ps)
   11/24/2004
   Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
   11/30/2004
   Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as
   Red Blood Cell Substitutes
   10/28/2004
   Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
   Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and
   Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
   10/21/2004
   Questions and Answers on ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible
   Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood
   and Blood Products''
   1/22/2004
   Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of
   West Nile Virus - Guidance for Industry and FDA Staff
   10/30/2003
   Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
   9/22/2003
   Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood
   Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
   9/16/2003

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   Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-
   Administered Questionnaires
   7/3/2003
   Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on
   Screening Tests for Syphilis
   6/25/2003
   Question and Answer on FDA Guidance Entitled ``Recommendations for the Assessment of Donor
   Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory
   Syndrome (SARS) or Exposure to SARS''
   4/25/2003
   Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product
   Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
   4/17/2003
   Questions and Answers on FDA Guidance Entitled ``Recommendations for Deferral of Donors and
   Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia
   Virus) and Certain Contacts of Smallpox Vaccine Recipients''
   1/15/2003
   Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood
   and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox
   Vaccine Recipients
   12/30/2002
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
   2/1/2002
   General Principles of Software Validation; Final Guidance for Industry and FDA Staff
   1/11/2002
   Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
   Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
   1/9/2002
   Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
   11/22/2001
   Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood
   Product Safety in Cases of Possible Exposure to Anthrax
   10/17/2001
   Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary
   Hemochromatosis
   8/22/2001
   Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood
   Components Intended for Transfusion or for Further Manufacture
   8/07/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
   7/19/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile
   Connecting Devices)
   7/19/2001
   Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the
   Collection and Processing of Blood and Blood Components
   7/19/2001
   Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and
   510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
   7/11/2001
   Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
   3/29/2001
   Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
    Technical Correction February 2001
   2/13/2001
   Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components
   Intended for Transfusion
   1/23/2001
   Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
   Blood Specimens
   6/23/2000
   Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to
   Malaria
   6/8/2000
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
   12/23/1999
   Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic
   Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
   12/14/1999
   Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
   Regulations (PDF - 26KB)
   7/15/1999
   Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured
   for Commercial Use
   5/20/1999
   Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products
   5/20/1999
   Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment
   Description Information for Human Blood and Blood Components Intended for Transfusion or for Further
   Manufacture and For the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an
   Antibiotic Drug for Human Use''
   5/10/1999
   Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
   Establishment Description Information for a Biological In Vitro Diagnostic Product
   3/8/1999

[[Page 48186]]

   Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment
   Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products
   2/17/1999
   Withdrawal of ``Guidance for Industry: Supplemental Testing and the Notification of Consignees of
   Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)''
   9/8/1998
   Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral
   Marker Testing
   6/11/1998
   Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results
   for Antibody to Hepatitis C Virus (Anti-HCV)
   3/20/1998
   Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in
   the Manufacture of Blood Products
   1/08/1998
   Guidance for Industry: Donor Screening for Antibodies to HTLV-II
   8/15/1997
   Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB)
   7/1997
   Guideline for Quality Assurance in Blood Establishments (PDF - 77KB)
   7/11/1995
   Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB)
   3/1992
   Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin
   (PDF - 1161KB)
   3/1992
   Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents
   and Anti-Human Globulin (PDF - 211KB)
   1992
   Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious
   Disease Markers (``High Risk'' Donors) (PDF - 176KB)
   10/26/1989
   Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect
   Antibodies to the Human Immunodeficiency Virus Type 1 (PDF - 1784KB)
   8/08/1989
   Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
   Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
   12/1987
   Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1189KB)
   8/1985
   Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB)
   6/1980
Cellular & Gene Therapy Guidance Documents
   Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
   Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
   Reconstitution for Specified Indications (PDF - 91KB)
   10/2009
   Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
   Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
   10/2009
   Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
   9/2009
   Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
   09/2009
   Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease
   03/2009
   Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
   10/9/2008
   Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
   (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
   4/9/2008
   Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
   (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
   4/9/2008
   Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility
   Testing of Cellular and Gene Therapy Products
   2/11/2008
   Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
   Tissue-Based Products
   8/8/2007
   Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
   Knee Cartilage
   7/6/2007
   Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
   11/28/2006
   Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in
   Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using
   Retroviral Vectors
   11/28/2006
   Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
   3/30/1998

[[Page 48187]]

   Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment
   Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)
   01/1997
CMC & GMP
   Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
   Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
   2/2010
   Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
   11/2008
   Process Validation: General Principles and Practices (PDF - 194KB)
   11/2008
   Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
   7/2008
   Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using
   Spore-Forming Microorganisms (PDF - 184KB)
   9/6/2007
   Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF -
   443KB)
   9/2006
   Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
    253KB)
   9/2006
   Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
   110KB)
   1/2006
   Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
   5/2005
   Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice (PDF -
   734KB)
   9/2004
   Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing,
   and Controls Information (PDF - 82KB)
   9/2003
   Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
   2/2003
   CVM GFI 153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use
   in Humans and Animals (PDF - 88KB)
   9/2002
   Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers (PDF - 15KB)
   5/2002
   IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF -
   30KB)
   5/2001
   Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB)
   3/2001
   Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation
   (PDF - 91KB)
   8/2000
   Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
   8/1999
   Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
   5/1999
   Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
   7/1998
   Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
   3/1998
   Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a
   Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (PDF - 44KB)
   8/1996
   Submission Documentation for Sterilization Process Validation in Applications for Human and
   Veterinary Drug Products (PDF - 57KB)
   11/1994
   Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
   Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
   12/1987
   Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB)
   7/14/1993
Clinical
   Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)
   7/2009
   Postmarketing Studies and Clinical Trials--Implementation of Section 505(o) of the Federal Food,
   Drug, and Cosmetic Act (PDF - 173KB)
   7/2009
   The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug
   Application (PDF - 421KB)
   6/2009
   Animal Models--Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
   2/2009
   Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
   Human Subject Protection (PDF - 61KB)
   1/2009
   Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB)
   5/2007
   Computerized Systems Used in Clinical Trials (PDF - 53KB)
   5/2007

[[Page 48188]]

   Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
    253KB)
   9/2006
   Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment (PDF - 205KB)
   6/2006
   Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
   that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
   4/25/2006
   The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial
   Sponsors
   3/2006
   Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)
   3/2006
   Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
   and Drug Administration Modernization Act of 1997 (PDF - 456KB)
   2/2006
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   2/2006
   Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
   9/2005
   Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult
   Healthy Volunteers (PDF - 702KB)
   7/2005
   Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3151KB)
   4/2005
   Premarketing Risk Assessment (PDF - 88KB)
   3/2005
   Development and Use of Risk Minimization Action Plans (PDF - 225KB)
   3/2005
   Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
   3/2005
   Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
   363KB)
   2/2005
   Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
   - 211KB)
   12/2004
   Available Therapy (PDF - 176KB)
   7/2004
   Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
   3/2004
   Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF -
   40KB)
   1/2004
   IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of
   Cancer (PDF - 188KB)
   1/2004
   Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
   (PDF - 389KB)
   7/2003
   Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
   on Dosing and Labeling (PDF - 222KB)
   5/2003
   Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications (PDF -
   221KB)
   4/2003
   Establishing Pregnancy Exposure Registries (PDF - 268KB)
   8/2002
   Special Protocol Assessment (PDF - 36KB)
   5/2002
   FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)
   11/2001
   Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
   10/2001
   IDE Financial Disclosure
   Acceptance of Foreign Clinical Studies (PDF - 12KB)
   3/2001
   Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
   11/2000
   Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
   10/2000
   Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB)
   6/2000
   In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
   for Dosing and Labeling (PDF - 44KB)
   11/2009
   Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment
   of Osteoarthritis (PDF - 40KB)
   7/1999
   Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of
   Rheumatoid Arthritis (RA) (PDF - 369KB)
   2/1999
   Population Pharmacokinetics (PDF - 135KB)
   2/1999
   FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (PDF - 58KB)
   12/1998

[[Page 48189]]

   General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF -
   37KB)
   11/1998
   Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (PDF - 129KB)
   5/1998
   Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128KB)
   5/1998
   Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
   Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
   11/1995
Devices
   Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (PDF -
   388KB)
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
   Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
   (510(k)s) (PDF Version) (PDF - 109KB)
   Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and
   Biological Products (PDF - 112KB)
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
   The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
   Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
   (PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
   Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and
   Answers (PDF Version) (PDF - 196KB)
   Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
   Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
   Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
   Version) (PDF - 127KB)
   In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
   Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version)
   (PDF - 139KB)
   In Vitro Diagnostic Multivariate Index Assays (PDF version) (PDF - 72KB)
   Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
   Submission (PDF Version) (PDF - 145KB)
   Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
   Applications (PMA) (PDF Version) (PDF - 127KB)
   Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
   Contained in Medical Devices (PDF version) (PDF - 342KB)
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
   that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
   Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
   Version) (PDF - 82KB)
   Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
   Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
   Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
   Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
   (PDF - 389KB)
   Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
   Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
   Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
   - 159KB)
   Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
    529KB)
   Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
   Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
   Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
   Staff - PDF (PDF - 548KB)
   Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
   Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
   Criteria (PDF Version) (PDF - 175KB)
Labeling & Promotion
   Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug
   and Biological Products (PDF - 163KB)
   Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
   Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
   - 295KB)
   Labeling for Human Prescription Drug and Biological Products--Determining Established Pharmacologic
   Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
   Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 387KB)
   Indexing Structured Product Labeling (PDF - 59KB)
   Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF Version)
   (PDF - 139KB)
   Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
   and Format (PDF - 52KB)
   Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
   Format (PDF - 127KB)
   Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human
   Prescription Drug and Biological Products--Content and Format (PDF - 58KB)
   Labeling for Human Prescription Drug and Biological Products--Implementing the New Content and Format
   Requirements (PDF - 213KB)
   Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
   Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
   363KB)
   Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic
   Devices Intended for Professional Use (PDF Version) (PDF - 1385KB)
   Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (PDF - 192KB)
   ``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms
   (PDF - 188KB)
   Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
   on Dosing and Labeling (PDF - 222KB)

[[Page 48190]]

   Content and Format for Geriatric Labeling (PDF - 38KB)
   Prescription Drug Advertising and Promotional Labeling (PDF - 28KB)
   In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
   for Dosing and Labeling (PDF - 44KB)
   Consumer-Directed Broadcast Advertisements (PDF - 36KB)
   Accelerated Approval Products--Submission of Promotional Materials (PDF - 17KB)
   Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 86KB)
   Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 -
   Elimination of Certain Labeling Requirements (PDF - 979KB)
Tissue Guidance Documents
   Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
   Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
   Cellular and Tissue-Based Products
   3/2009
   Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for
   Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   1/16/2009
   Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps) - Small Entity Compliance Guide
   8/24/2007
   Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
   Knee Cartilage
   7/6/2007
   Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
   9/20/2006
   Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for
   Transplantation
   3/8/2002
   Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
   Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
   Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   4/25/2008
   Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or
   Diagnostic Tests
   4/16/2008
   Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
   Tissue-Based Products
   8/8/2007
   Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
   Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
   Based Products (HCT[sol]Ps)
   11/12/2004
   Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
   Blood Specimens
   6/23/2000
   Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1)--Manufacturing Arrangements
   9/8/2006
   Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to
   Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
   11/30/2005
   Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally
   Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)
   7/23/2007
   Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and
   Storage Container
   1/31/2007
   Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord
   Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies
   1/16/2007
   Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation
   (PDF - 59KB)
Vaccine Guidance Documents
   Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological
   Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (PDF - 406KB)
   3/2010
   Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
   09/2009
   Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global
   Infectious Diseases
   9/8/2008
   Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
   10/29/2007
   Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
   Preventive Vaccine Clinical Trials
   9/27/2007
   Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
   5/31/2007
   Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated
   Influenza Vaccines
   5/31/2007
   Draft Guidance for Industry: Characterization and Qualification of Cell Substrates and Other
   Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of
   Infectious Diseases
   9/28/2006
   Guidance for Industry: Development of Preventive HIV Vaccines for Use in Pediatric Populations
   5/4/2006
   Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and
   Therapeutic Vaccines for Infectious Disease Indications
   2/13/2006

[[Page 48191]]

   Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease
   Indications
   2/17/2005
   Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions,
   and Precautionary Information
   10/1/2004
   Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products
   Including Vaccines
   3/12/2001
   Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
   Revised Protocol
   11/20/2000
   Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines
   for Infectious Disease Indications
   9/8/2000
   Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
   Establishment Description Information for a Vaccine or Related Product
   1/5/1999
   Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) (PDF
   - 63KB)
   9/8/1998
   Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases:
   Production, Testing and Clinical Studies (PDF - 49KB)
   4/10/1997
Xenotransplantation Guidance Documents
   Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of
   Xenotransplantation Products in Humans
   4/3/2003
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
   2/1/2002
   Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
   Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
   12/23/1999
   PHS Guideline on Infectious Disease Issues in Xenotransplantation
   1/19/2001
   Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in
   Humans
   4/6/1999

III. Center for Drug Evaluation and Research (CDER)

    For information on a specific guidance document or to obtain a 
paper copy, contact:
    Division of Drug Information, Office of Training and 
Communications, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver 
Spring, MD 20993, 1-888-463-6332 or 301-796-3400, e-mail: 
druginfo@fda.hhs.gov, http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/default.htm.
    The following list of withdrawn CDER guidance documents was 
obtained from FDA's Web site on April 21, 2010:

----------------------------------------------------------------------------------------------------------------
                                                               Level at Date     Publication/
                  Title                         Subject          of Issue       Withdrawal Date       Status
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 1--Reviewable Units for Fast Track
 Products under PDUFA
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 2--Scientific Feedback and Interactions
 during Development of Fast Track
 Products under PDUFA
----------------------------------------------------------------------------------------------------------------
Continuous Marketing Applications: Pilot  Procedural          Level 1         04/09/2010          Withdrawn
 2--Scientific Feedback and Interactions
 during Development of Fast Track
 Products under PDUFA; Paperwork
 Reduction Act Burden Statement
----------------------------------------------------------------------------------------------------------------
Clinical Evaluation of Lipid-Altering     Clinical Medical    Level 1         04/16/2010          Withdrawn
 Agents                                    Draft
----------------------------------------------------------------------------------------------------------------

    The following list of current CDER guidance documents was obtained 
from FDA's Web site on April 21, 2010:

------------------------------------------------------------------------
                                                                 Issue
                  Title and Format                      Type      Date
------------------------------------------------------------------------
Advertising
Accelerated Approval Products: Submission of          Draft    3/26/1999
 Promotional Materials (PDF - 17 KB)
Aerosol Steroid Product Safety Information in         Final    12/1997
 Prescription Drug Advertising and Promotional
 Labeling (PDF - 84 KB)
Brief Summary: Disclosing Risk Information in         Draft    2/4/2004
 Consumer-Directed Print Advertisements (PDF - 192
 KB)
   Labeling Example (PDF - 105 KB)            .......  .........
   Labeling Example; Consumer-Friendly        .......  .........
   Version (PDF - 95KB)

[[Page 48192]]

Consumer-Directed Broadcast Advertisements (PDF -     Final    8/1999
 36KB)
Questions and Answers (PDF - 83 KB)
Consumer-Directed Broadcast Advertising of            Draft    1/26/2004
 Restricted Devices (PDF - 41 KB)
``Help-Seeking'' and Other Disease Awareness          Draft    1/26/2004
 Communications by or on Behalf of Drug and Device
 Firms (PDF - 188 KB)
Industry-Supported Scientific and Educational         Final    12/3/1997
 Activities (PDF - 429 KB)
Presenting Risk Information in Prescription Drug and  Draft    5/26/2009
 Medical Device Promotion (PDF - 387 KB)
Product Name Placement, Size, and Prominence in       Draft    1/1999
 Advertising and Promotional Labeling (PDF - 86KB)
Biopharmaceutics
Bioanalytical Method Validation (PDF - 63 KB)         Final    5/2001
Bioavailability and Bioequivalence Studies for Nasal  Draft    4/2/2003
 Aerosols and Nasal Sprays for Local Action (PDF -             4/11/2003
 519 KB)
   Statistical Information from the June      .......  .........
   1999 Draft Guidance and Statistical Information
   for In Vitro Bioequivalence Data (PDF - 186 KB)
Bioavailability and Bioequivalence Studies for        Final    3/2003
 Orally Administered Drug Products - General
 Considerations (PDF - 268 KB)
Cholestyramine Powder in Vitro Bioequivalence (PDF -  Final    7/15/93
 35 KB) (Intermin Guidance)
Clozapine Tablets: In Vivo Bioequivalence and In      Final    6/17/2005
 Vitro Dissolution Testing (PDF - 78 KB)
Conjugated Estrogens, USP-LC-MS Method for Both       Draft    8/12/2005
 Qualitative Chemical Characterization and            Withdra
 Documentation of Qualitative Pharmaceutical           wn
 Equivalence.                                         FR
                                                       Notice
Corticosteroids, Dermatologic (topical) In Vivo (PDF  Final    6/2/1995
 - 3 MB) (Issued 6/2/1995, Posted 3/6/1998)
Dissolution Testing of Immediate Release Solid Oral   Final    8/1997
 Dosage Forms (PDF - 130 KB) (Issued 8/1997, Posted
 8/25/1997)
Extended Release Oral Dosage Forms: Development,      Final    9/1997
 Evaluation, and Application of In Vitro/In Vivo
 Correlations (PDF - 170 KB)
Food-Effect Bioavailability and Fed Bioequivalence    Final    12/2002
 Studies(PDF - 166 KB)
Metaproterenol Sulfate and Albuterol Metered Dose     Final    6/27/1989
 Inhalers In Vitro (PDF - 744 KB)
Potassium Chloride (slow-release tablets and          Final    6/6/1994
 capsules) In Vivo Bioequivalence and In Vitro
 Dissolution Testing (PDF - 718 KB)
Statistical Approaches to Establishing                Final    2/2001
 Bioequivalence (PDF - 130 KB)
Waiver of In Vivo Bioavailability and Bioequivalence  Final    8/2000
 Studies for Immediate-Release Solid Oral Dosage
 Forms Based on a Biopharmaceutics Classification
 System.(PDF - 143 KB).
CMC - Microbiology (Chemistry, Manufacturing, and Controls)
Submission Documentation for Sterilization Process    Final    11/1994
 Validation in Applications for Human and Veterinary
 Drug Products (PDF - 57 KB)
Submission of Documentation in Applications for       Final    2/25/2010
 Parametric Release of Human and Veterinary Drug
 Products Terminally Sterilized by Moist Heat
 Processes (PDF - 76 KB)
Chemistry, Manufacturing, and Controls (CMC)
Analytical Procedures and Methods Validation.(PDF -   Draft    8/2000
 91 KB)
Assay Development for Immunogenicity Testing of       Draft    12/3/2009
 Therapeutic Proteins (PDF - 161 KB)
BACPAC I: Intermediates in Drug Substance Synthesis;  Final    Withdrawn
 Bulk Actives Postapproval Changes: Chemistry,                  as per
 Manufacturing, and Controls Documentation 2/2001               FR
                                                                notice
                                                                June 1,
                                                                2006
Botanical Drug Products (PDF - 437 KB)                Final    6/2004
Changes to an Approved Application for Specified      Final    7/1997
 Biotechnology and Specified Synthetic Biological
 Products (PDF - 33 KB)
Changes to an Approved NDA or ANDA (PDF - 108 KB)     Final    4/2004
Changes to an Approved NDA or ANDA: Questions and     Final    1/2001
 Answers (PDF - 35 KB)
Changes to an Approved NDA or ANDA; Specifications--  Final    11/19/
 Use of Enforcement Discretion for Compendial                   2004
 Changes (PDF - 18 KB)
Comparability Protocols--Chemistry, Manufacturing,    Draft    2/2003
 and Controls Information (PDF - 240 KB)
Container Closure Systems for Packaging Human Drugs   Final    5/1999
 and Biologics (PDF - 164 KB)
   [Container Closure Systems for Packaging   .......  5/2002
   Human Drugs and Biologics--Questions and Answers
   (PDF - 15 KB)
Demonstration of Comparability of Human Biological    Final    4/1996
 Products, Including Therapeutic Biotechnology-
 derived Products
Development of New Stereoisomeric Drugs               Final    5/1/1992
Drug Master Files                                     Final    9/1/1989
 Current DMF Information(e.g. lists, addresses,
 guidances, etc.)
Drug Master Files for Bulk Antibiotic Drug            Final    11/1999
 Substances (PDF - 23 KB)
Drug Product: Chemistry, Manufacturing, and Controls  Draft    Withdrawn
 Information 1/2003                                             as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Drug Substance: Chemistry, Manufacturing, and         Draft    Withdrawn
 Controls Information 1/2004                                    as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Drugs, Biologics, and Medical Devices Derived from    Draft    9/11/2003
 Bioengineered Plants for Use in Humans and Animals
 (PDF - 88 KB)
Environmental Assessment of Human Drug and Biologics  Final    7/1998
 Applications (PDF - 188 KB)
Format and Content of the Chemistry, Manufacturing    Final    Withdrawn
 and Controls Section of an Application* 2/1987                 as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Format and Content for the CMC Section of an Annual   Final    9/1/1994
 Report (PDF - 29 KB)

[[Page 48193]]

Incorporation of Physical-Chemical Identifiers into   Draft    7/13/2009
 Solid Oral Dosage Form Drug Products for
 Anticounterfeiting (PDF - 79 KB)
INDs for Phase 2 and Phase 3 Studies Chemistry,       Final    5/20/2003
 Manufacturing, and Controls Information (PDF - 193
 KB)
IND Meetings for Human Drugs and Biologics            Final    5/2001
 Chemistry, Manufacturing, and Controls Information
 (PDF - 30 KB)
Interpreting Sameness of Monoclonal Antibody          Draft    7/24/1999
 Products Under the Orphan Drug Regulations (PDF -
 26 KB)
Liposome Drug Products: Chemistry, Manufacturing,     Draft    7/2002
 and Controls; Human Pharmacokinetics and
 Bioavailability; and Labeling Documentation.(PDF -
 45 KB)
Monoclonal Antibodies Used as Reagents in Drug        Final    3/2001
 Manufacturing (PDF - 29 KB)
Metered Dose Inhaler (MDI) and Dry Powder Inhaler     Draft    11/13/
 (DPI) Drug Products (PDF - 361 KB)                             1998
Nasal Spray and Inhalation Solution, Suspension, and  Final    7/2002
 Drug Products (PDF - 116 KB)
NDAs: Impurities in Drug Substances (PDF - 11 KB)     Final    2/2000
Orally Disintegrating Tablets (PDF - 52 KB)           Final    12/17/
                                                                2008
PAC-ATLS: Postapproval Changes - Analytical Testing   Final    4/28/1998
 Laboratory Sites (PDF - 76 KB)
Residual Solvents in Drug Products Marketed in the    Final    11/24/
 United States (PDF - 52 KB)                                    2009
Reviewer Guidance, Validation of Chromatographic      Final    11/1994
 Methods (PDF - 703 KB) (revised to include
 graphics, 5/14/2007)
The Sourcing and Processing of Gelatin to Reduce the  Final    12/20/
 Potential Risk Posed by Bovine Spongiform                      2000
 Encephalopathy (BSE)(PDF - 790 KB)
Stability Testing of Drug Substances and Drug         Draft    Withdrawn
 Products 6/5/1998                                              as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Submission of Chemistry, Manufacturing, and Controls  Final    Withdrawn
 Information for Synthetic Peptide Substances 11/               as per
 1994                                                           FR
                                                                notice
                                                                June 1,
                                                                2006
Submitting Documentation for the Manufacturing of     Final    2/1987
 and Controls for Drug Products*(PDF - 1.02 MB)
Submitting Documentation for the Stability of Human   Final    Withdrawn
 Drugs and Biologics* (Issued , Posted 3/2/1998)                as per
                                                                FR
                                                                notice
                                                                June 1,
                                                                2006
Submitting Samples and Analytical Data for Methods    Final    2/1987
 Validation
Submitting Supporting Documentation in Drug           Final    2/1987
 Applications for the Manufacture of Drug Substances
 (PDF - 94 KB)
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms:  Final    11/1995
 Scale-Up and Post-Approval Changes: Chemistry,
 Manufacturing and Controls, In Vitro Dissolution
 Testing, and In Vivo Bioequivalence Documentation
 (PDF - 60 KB)
SUPAC-IR Questions and Answers about SUPAC-IR         Final    2/18/1997
 Guidance
SUPAC-IR/MR: Immediate Release and Modified Release   Final    1/1999
 Solid Oral Dosage Forms Manufacturing Equipment
 Addendum (PDF - 117 KB)
SUPAC-MR: Modified Release Solid Oral Dosage Forms    Final    Issued 10/
 Scale-Up and Postapproval Changes: Chemistry,                  6/1997
 Manufacturing, and Controls; In Vitro Dissolution
 Testing and In Vivo Bioequivalence Documentation
 (PDF - 215 KB)
SUPAC-SS: Nonsterile Semisolid Dosage Forms           Draft    12/1998
 Manufacturing Equipment Addendum (PDF - 61 KB)
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-   Final    5/1997
 Up and Post-Approval Changes: Chemistry,
 Manufacturing and Controls; In Vitro Release
 Testing and In Vivo Bioequivalence Documentation
 (PDF - 118 KB)
Clinical / Antimicrobial
Acute Bacterial Exacerbations of Chronic Bronchitis   Draft    8/21/2008
 in Patients with Chronic Obstructive Pulmonary
 Disease: Developing Antimicrobial Drugs for
 Treatment(PDF - 422 KB)
Acute Bacterial Meningitis--Developing Antimicrobial  Draft    7/22/1998
 Drugs for Treatment(PDF - 42 KB)
Acute Bacterial Sinusitis--Developing Antimicrobial   Draft    10/29/
 Drugs for Treatment (PDF - 155 KB)                             2007
Acute or Chronic Bacterial Prostatitis--Developing    Draft    7/22/1998
 Antimicrobial Drugs for Treatment (PDF - 42 KB)
Acute Bacterial Otitis Media: Developing Drugs for    Draft    1/17/2008
 Treatment (PDF - 173 KB)
Antibacterial Drug Products: Use of Noninferiority    Draft    10/12/
 Studies to Support Approval (PDF - 41 KB)                      2007
Antiviral Product Development--Conducting and         Final    6/2/2006
 Submitting Virology Studies to the Agency (PDF -
 208 KB)
   Guidance for Submitting HIV Resistance     .......  .........
   Data (PDF - 293 KB)
   Guidance for Submitting Influenza          .......  .........
   Resistance Data (PDF - 385 KB)
   Guidance for Submitting HBV Resistance     .......  .........
   Data (PDF - 123 KB)
   Guidance for Submitting HCV Resistance     .......  .........
   Data (PDF - 122 KB)
Antiretroviral Drugs Using Plasma HIV RNA             Final    10/2002
 Measurements--Clinical Considerations for
 Accelerated and Traditional Approval (PDF - 254 KB)
Bacterial Vaginosis--Developing Antimicrobial Drugs   Draft    7/22/1998
 for Treatment (PDF - 53 KB)
Catheter-Related Bloodstream Infections - Developing  Draft    10/1999
 Antimicrobial Drugs for Treatment (PDF - 54 KB)
Clinical Development and Labeling of Anti-Infective   Final    10/1992
 Drug Products (PDF - 5 MB)                                     Revised
                                                                2/12/
                                                                2001
Clinical Evaluation of Anti-Infective Drugs           Final    9/77
 (Systemic)(PDF - 1 MB)
Community-Acquired Bacterial Pneumonia: Developing    Draft    3/19/2009
 Drugs for Treatment (PDF - 418 KB)
Complicated Urinary Tract Infections and              Draft    7/22/1998
 Pyelonephritis--Developing Antimicrobial Drugs for
 Treatment (PDF - 35 KB)
Developing Antimicrobial Drugs--General               Draft    7/22/1998
 Considerations for Clinical Trials (PDF - 134 KB)
 [Main Document]
Developing Antimicrobial Drugs to Treat Inhalational  Draft    3/15/2002
 Anthrax (Post Exposure)--(PDF - 51 KB)
Empiric Therapy of Febrile Neutropenia--Developing    Draft    7/22/1998
 Antimicrobial Drugs for Treatment (PDF - 33 KB)
Evaluating Clinical Studies Of Antimicrobials In The  Draft    2/18/1997
 Division Of Anti-Infective Drug Products (PDF - 267
 KB)

[[Page 48194]]

Helicobacter pylori-Associated Duodenal Ulcer         Draft    10/2/2009
 Disease in Adults: Developing Drugs for Treatment
 (PDF - 145 KB)
Influenza: Developing Drugs for Treatment and/or      Draft    2/19/2009
 Prophylaxis(PDF - 225 KB)
Lyme Disease--Developing Antimicrobial Drugs for      Draft    7/22/1998
 Treatment (PDF - 42 KB)
Microbiological Data for Systemic Antibacterial Drug  Draft    9/16/2009
 Products--Development, Analysis, and Presentation
 (PDF - 272 KB)
Nosocomial Pneumonia--Developing Antimicrobial Drugs  Draft    7/22/1998
 for Treatment (PDF - 49 KB)
Role of HIV Drug Resistance Testing in                Final    10/30/
 Antiretroviral Drug Development (PDF - 244 KB)                 2007
Secondary Bacterial Infections of Acute Bronchitis--  Draft    7/22/1998
 Developing Antimicrobial Drugs for Treatment (PDF -
 10 KB)
Smallpox (Variola) Infection: Developing Drugs for    Draft    11/21/
 Treatment or Prevention (PDF - 257 KB)                         2007
Streptococcal Pharyngitis and Tonsillitis--           Draft    7/22/1998
 Developing Antimicrobial Drugs for Treatment (PDF -
 29 KB)
Uncomplicated and Complicated Skin and Skin           Draft    7/22/1998
 Structure Infections--Developing Antimicrobial
 Drugs for Treatment (PDF - 49 KB)
Uncomplicated Gonorrhea--Developing Antimicrobial     Draft    7/22/
 Drugs for Treatment (PDF - 30 KB)                              1998,
Uncomplicated Urinary Tract Infections--Developing    Draft    7/22/1998
 Antimicrobial Drugs for Treatment (PDF - 42 KB)
Vaccinia Virus--Developing Drugs to Mitigate          Draft    3/8/2004
 Complications from Smallpox Vaccination (PDF - 139
 KB)
Vulvovaginal Candidiasis--Developing Antimicrobial    Draft    7/22/1998
 Drugs for Treatment (PDF - 42 KB)
Clinical / Medical
Acceptance of Foreign Clinical Studies (PDF - 12 KB)  Final    3/12/2001
Acne Vulgaris: Developing Drugs for Treatment (PDF -  Draft    9/16/2005
 284 KB)
Adaptive Design Clinical Trials for Drugs and         Draft    2/25/2010
 Biologics (PDF - 424 KB)
Allergic Rhinitis: Clinical Development Programs for  Draft    6/2000
 Drug Products (PDF - 68 KB)
Antianxiety Drugs--Clinical Evaluation (PDF - 2 MB)   Final    9/1977
Antidepressant Drugs--Clinical Evaluation (PDF - 2    Final    9/1977
 MB)
Assessment of Abuse Potential of Drugs (PDF - 138     Draft    1/26/2010
 KB)
Available Therapy (PDF - 176 KB)                      Final    7/22/2004
Calcium DTPA and Zinc DTPA Drug Products -            Final    8/13/2004
 Submitting a New Drug Application (PDF - 157 KB)
Cancer Drug and Biological Products - Clinical Data   Final    10/11/
 in Marketing Applications (PDF - 39 KB)                        2001
Chronic Cutaneous Ulcer and Burn Wounds--Developing   Final    6/1/2006
 Products for Treatment(PDF - 205 KB)
Chronic Obstructive Pulmonary Disease: Developing     Draft    11/8/2007
 Drugs for Treatment (PDF - 153 KB)
Clinical Development Programs for Drugs, Devices,     Draft    7/07/1999
 and Biological Products Intended for the Treatment
 of Osteoarthritis (PDF - 40 KB)
Clinical Development Programs for Drugs, Devices,     Final    1/1999
 and Biological Products for the Treatment of
 Rheumatoid Arthritis (RA) (PDF - 369 KB)
Clinical Evaluation of Analgesic Drugs (Withdrawn     Final    Withdrawn
 per August 5, 2003, Federal Register Notice)                  8/5/2003
Clinical Evaluation of Antacid Drugs (Withdrawn per   Final    Withdrawn
 July 20, 2004, Federal Register notice.)                      7/20/2004
Clinical Evaluation of Anti-Inflammatory and          Final    Withdrawn
 Antirheumatic Drugs (adults and children)                     5/29/2008
Clinical Evaluation of Antidiarrheal Drugs            Final    Withdrawn
 (Withdrawn per July 20, 2004, Federal Register       Withdra  7/20/2004
 notice.)                                              wn
Clinical Evaluation of Antiepileptic Drugs (adults    Final    1/1981
 and children) (PDF - 1,007 KB)
Clinical Evaluation of Gastric Secretory Depressant   Final    Withdrawn
 (GSD) Drugs (Withdrawn per July 20, 2004, Federal    Withdra  7/20/2004
 Register notice.)                                     wn
Clinical Evaluation of General Anesthetics (PDF -     Final    5/1982
 890 KB)
Clinical Evaluation of Laxative Drugs (Withdrawn per  Final    Withdrawn
 July 20, 2004, Federal Register notice.)             Withdra  7/20/2004
                                                       wn
Clinical Evaluation of Lipid-Altering Agents (PDF -   Draft    Withdrawn
 36 KB)                                                        4/19/2010
Clinical Evaluation of Radiopharmaceutical Drugs      Final    Withdrawn
 (Withdrawn per July 20, 2004, Federal Register       Withdra  7/20/2004
 notice.)                                              wn
Clinical Trial Endpoints for the Approval of Cancer   Final    5/15/2007
 Drugs and Biologics (PDF - 145 KB)
Collection of Race and Ethnicity Data in Clinical     Final    9/16/2005
 Trials (PDF - 70 KB)
Content and Format of Investigational New Drug        Final    11/1995
 Applications (INDs) for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-derived Products (PDF - 42 KB)
    [cir] Questions and Answers: Content and Format   .......  .........
     of INDs for Phase 1 Studies of Drugs, Including
     Well-Characterized, Therapeutic, Biotechnology-
     Derived Products (PDF - 14 KB) (10/2000)
Developing Medical Imaging Drug and Biological        Final    6/17/2004
 Products
   Part 1: Conducting Safety Assessments      .......  .........
   (PDF - 271 KB)
   Part 2: Clinical Indications (PDF - 231    .......  .........
   KB)
   Part 3: Design, Analysis, and              .......  .........
   Interpretation of Clinical Studies(PDF - 307 KB)
Developing Products for Weight Management Revision 1  Draft    2/14/2007
 (PDF - 150 KB)
Development and Use of Risk Minimization Action       Final    3/24/2005
 Plans (PDF - 225 KB)
Development of Parathyroid Hormone for the            Draft    5/2000
 Prevention and Treatment of Osteoporosis (PDF - 20
 KB)
Diabetes Mellitus: Developing Drugs and Therapeutic   Draft    2/29/2008
 Biologics for Treatment and Prevention (PDF - 265
 KB)
Diabetes Mellitus--Evaluating Cardiovascular Risk in  Final    12/17/
 New Antidiabetic Therapies to Treat Type 2 Diabetes            2008
 (PDF - 51 KB)
Drugs, Biologics, and Medical Devices Derived from    Draft    9/6/2002
 Bioengineered Plants for Use in Humans and Animals
 (PDF - 88 KB)
Establishing Pregnancy Exposure Registries (PDF -     Final    8/2002
 268 KB)
Establishment and Operation of Clinical Trial Data    Final    3/27/2006
 Monitoring Committees (PDF - 333 KB)

[[Page 48195]]

Estrogen and Estrogen/Progestin Drug Products to      Draft    1/2003
 Treat Vasomotor Symptoms and Vulvar and Vaginal
 Atrophy Symptoms--Recommendations for Clinical
 Evaluation (PDF - 198 KB)
Evaluating the Risks of Drug Exposure in Human        Final    4/27/2005
 Pregnancies (PDF - 3 MB)
Exercise-Induced Bronchospasm (EIB)--Development of   Draft    2/2002
 Drugs to Prevent EIB (PDF - 27 KB)
Exocrine Pancreatic Insufficiency Drug Products--     Final    4/13/2006
 Submitting New Drug Applications(PDF - 149 KB)
Female Sexual Dysfunction: Clinical Development of    Draft    5/2000
 Drug Products for Treatment (PDF - 23 KB)
FDA Approval of New Cancer Treatment Uses for         Final    12/1998
 Marketed Drug and Biological Products (PDF - 58 KB)
FDA Requirements for Approval of Drugs to Treat Non-  Final    Posted 3/
 Small Cell Lung Cancer (PDF - 2 MB)                            2/1998
FDA Requirements for Approval of Drugs to Treat       Final    Withdrawn
 Superficial Bladder Cancer (Withdrawn per July 20,   Withdra  7/20/2004
 2004, Federal Register notice.)                       wn
Format and Content of the Clinical and Statistical    Final    7/1988
 Sections of an Application (PDF - 1 MB)
Formatting, Assembling and Submitting New Drug and    Final    2/1987
 Antibiotic Applications* (PDF - 2 MB)
General Considerations for the Clinical Evaluation    Final    .........
 of Drugs (PDF - 1 MB)
General Considerations for the Clinical Evaluation    Final    9/77
 of Drugs in Infants and Children (PDF 2 MB)
Gingivitis: Development and Evaluation of Drugs for   Draft    6/24/
 Treatment or Prevention (PDF -91KB)                            2005
Good Pharmacovigilance Practices and                  Final    3/24/2005
 Pharmacoepidemiologic Assessment (PDF - 220 KB)
Guidance for Clinical Trial Sponsors On the           Final    3/27/2006
 Establishment and Operation of Clinical Trial Data
 Monitoring Committees (PDF - 333KB)
Guidance for Institutional Review Boards, Clinical    Draft    8/29/2006
 Investigators, and Sponsors: Exception from
 Informed Consent Requirements for Emergency
 Research (PDF - 2 MB)
Guidance for the Development of Vaginal               Final    3/2/1998
 Contraceptive Drugs (NDA)(PDF - 465 KB)
Hypnotic Drugs--Clinical Evaluation (PDF - 2MB)       Final    9/77
IND Exemptions for Studies of Lawfully Marketed Drug  Final    Revised
 or Biological Products for the Treatment of Cancer            1/15/2004
 (PDF - 188 KB)
Inhalation Drug Products Packaged in Semipermeable    Draft    7/2002
 Container Closure Systems (PDF - 27 KB)
Integration of Dose-Counting Mechanisms into MDI      Final    3/2003
 Drug Products (PDF - 126 KB)
Internal Radioactive Contamination--Development of    Final    3/1/2006
 Decorporation Agents (PDF - 177 KB)
Irritable Bowel Syndrome--Clinical Evaluation of      Draft    3/22/2010
 Products for Treatment (PDF 221 KB)
Levothyroxine Sodium Tablets - In Vivo                Final    2/2001
 Pharmacokinetic and Bioavailability Studies and In
 Vitro Dissolution Testing (PDF - 27 KB)
Local Anesthetics--Clinical Evaluation (PDF - 1 MB    Final    3/2/1998
Malaria: Developing Drug and Nonvaccine Biological    Draft    6/6/2007
 Products for Treatment and Prophylaxis (PDF - 344
 KB)
MDI and DPI Drug Products--Clinical Development       Final    9/19/1994
 Programs for (PDF - 699 KB)
Non-Inferiority Clinical Trials (PDF - 565 KB)        Draft    2/26/2010
Pediatric Use Supplements--Content and Format (PDF -  Final    5/1996
 24 KB)
Oncologic Drugs Advisory Committee Discussion on FDA  Final    Posted
 Requirements or Approval of New Drugs for Treatment           3/2/1998
 of Colon and Rectal Cancer (PDF - 2 MB)
Orally Inhaled and Intranasal Corticosteroids:        Final    3/5/2007
 Evaluation of the Effects on Growth in Children
 (PDF - 247 KB)
OTC Treatment of Herpes Labialis with Antiviral       Draft    Withdrawn
 Agents (PDF - 15 KB)                                          3/18/2010
Patient-Reported Outcome Measures: Use in Medical     Final    12/8/2009
 Product Development to Support Labeling Claims (PDF
 -295 KB)
Pediatric Oncology Studies In Response to a Written   Draft    6/2000
 Request (PDF - 30 KB)
Postmarketing Adverse Experience Reporting for Human  Final    8/27/1997
 Drug and Licensed Biological Products:
 Clarification of What to Report (PDF - 95 KB)
Postmarketing Reporting of Adverse Drug Experiences   Final    3/1992
 (PDF - 7 MB)
Preclinical and Clinical Evaluation of Agents Used    Draft    Withdrawn
 in the Prevention or Treatment of Postmenopausal     Withdra  12/2009
 Osteoporosis (PDF - 50 KB) Withdrawn                  wn
Premarketing Risk Assessment(PDF - 88 KB)             Final    3/24/2005
Providing Clinical Evidence of Effectiveness for      Final    5/14/1998
 Human Drug and Biological Products (PDF - 129 KB)
Prussian Blue Drug Products--Submitting a New Drug    Final    1/2003
 Application (PDF - 178 KB)
Psychoactive Drugs in Infants and Children--Clinical  Final    3/2/1998
 Evaluation (PDF - 18 MB)
The Radioactive Drug Research Committee: Human        Draft    6/2/2009
 Research Without An Investigational New Drug
 Application (PDF - 421 KB)
Recommendations for Complying with the Pediatric      Draft    Posted
 Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56 KB)           12/1/2000
Sinusitis: Designing Clinical Development Programs    Draft    Posted
 of Nonantimicrobial Drugs for Treatment (PDF - 113            11/21/
 KB)                                                            2006
Study and Evaluation of Gender Differences in the     Final    7/22/1993
 Clinical Evaluation of Drugs (PDF - 2 MB)
Study of Drugs Likely to be used in the Elderly (PDF  Final    11/1989
 - 1MB)
Submission of Abbreviated Reports and Synopses in     Final    8/1999
 Support of Marketing Applications (PDF - 43 KB)
Summary for New Drug and Antibiotic Applications--    Final    2/1987
 Format and Content of the Summary for New Drug and
 Antibiotic Applications (PDF - 1 MB)
Systemic Lupus Erythematosus--Developing Drugs for    Draft    3/28/2005
 Treatment (PDF - 403 KB)
The Use of Clinical Holds Following Clinical          Final    9/2004
 Investigator Misconduct (PDF - 33 KB)
Waiver of IRB Requirements for Drug and Biological    Final    1/2006
 Product Studies (PDF - 33 KB)
Clinical Pharmacology
Clinical Lactation Studies--Study Design, Data        Draft    Issued
 Analysis, and Recommendations for Labeling (PDF -             2/7/05
 363 KB)
Drug Interaction Studies--Study Design, Data          Draft    Issued
 Analysis, and Implications for Dosing and Labeling            9/11/2006
 (PDF - 253 KB)

[[Page 48196]]

Drug Metabolism/Drug Interaction Studies in the Drug  Final    4/1997
 Development Process: Studies In Vitro (PDF - 109
 KB)
Exposure-Response Relationships--Study Design, Data   Final    5/5/2003
 Analysis, and Regulatory Applications (PDF - 221
 KB)
Format and Content of the Human Pharmacokinetics and  Final    2/1987
 Bioavailability Section of an Application (PDF -
 519 KB)
General Considerations for Pediatric Pharmacokinetic  Draft    11/1998
 Studies for Drugs and Biological Products (PDF - 37
 KB)
In Vivo Drug Metabolism/Drug Interaction Studies -    Final    11/24/
 Study Design, Data Analysis, and Recommendations               1999
 for Dosing and Labeling (PDF - 44 KB)
Pharmacokinetics in Patients with Impaired Renal      Draft    3/17/2010
 Function--Study Design, Data Analysis, and Impact
 on Dosing and Labeling (PDF - 151 KB)
Pharmacokinetics in Patients with Impaired Hepatic    Final    Posted
 Function: Study Design, Data Analysis, and Impact             5/30/2003
 on Dosing and Labeling (PDF - 222 KB)
Pharmacokinetics in Patients with Impaired Renal      Final    5/14/1998
 Function (PDF - 128 KB)
Pharmacokinetics in Pregnancy--Study Design, Data     Draft    10/29/
 Analysis, and Impact on Dosing and Labeling (PDF -             2004
 324 KB)
Population Pharmacokinetics (PDF - 135 KB)            Final    2/1999
Combination Products
Coronary Drug-Eluting Stents-Nonclinical and          .......  .........
 Clinical Studies (PDF - 120 KB)
   Coronary Drug-Eluting Stents--Nonclinical  .......  .........
   and Clinical Studies -Companion Document (PDF -
   295 KB)
Current Good Manufacturing Practices (CGMPs)/Compliance
Bar Code Label Requirements--Questions and Answers    Final    10/5/2006
 (PDF - 101 KB)
Comparability Protocols - Protein Drug Products and   Draft    9/3/2003
 Biological Products - Chemistry, Manufacturing, and
 Controls Information (PDF - 82 KB)
Compressed Medical Gases                              Final    2/1989
Computerized Systems Used in Clinical Investigations  Final    5/10/2007
 (PDF - 53 KB)
Current Good Manufacturing Practice for Combination   Draft    9/29/2004
 Products (PDF - 350 KB)
Current Good Manufacturing Practice for Medical       Draft    5/6/2003
 Gases (PDF - 437 KB)
Current Good Manufacturing Practice for Phase 1       Final    7/14/2008
 Investigational Drugs (PDF - 132 KB)
Dosage Delivery Devices for OTC Liquid Drug Products  Draft    11/04/
 (PDF -93 KB)                                                   2009
Expiration Dating and Stability Testing of Solid      Final    6/27/1997
 Oral Dosage Form Drugs Containing Iron (PDF - 88
 KB)
Expiration Dating of Unit-Dose Repackaged Drugs:      Draft    5/27/2005
 Compliance Policy Guide (PDF - 19 KB)
Formal Dispute Resolution: Scientific and Technical   Final    1/11/2006
 Issues Related to Pharmaceutical CGMP (PDF - 110
 KB)
General Principles of Process Validation              Final    5/1987
Good Laboratory Practice Regulations Questions and    Final    3/2/1998
 Answers (PDF - 2 MB)
Guidance for Hospitals, Nursing Homes, and Other      Final    4/5/2001
 Health Care Facilities - FDA Public Health Advisory
 (PDF - 19 KB)
Guidance for IRBs, Clinical Investigators, and        Draft    8/29/2006
 Sponsors: Exception from Informed Consent
 Requirements for Emergency Research (21 CFR 50.24)
 (PDF - 3 MB)
 Draft released for comment
Guideline for Validation of Limulus Amebocyte Lysate  Final    Posted
 Test as an End-Product Endotoxin Test for Human and           3/2/1998
 Animal Parenteral Drugs, Biological Products, and
 Medical Devices (PDF - 4 MB)
Investigating Out-of-Specification Test Results for   Final    10/11/
 Pharmaceutical Production (PDF - 98 KB)                        2006
Manufacturing, Processing, or Holding Active          Draft    4/17/1998
 Pharmaceutical Ingredients (PDF - 150 KB)
Marketed Unapproved Drugs--Compliance Policy Guide    Final    6/8/2006
 (PDF - 66 KB)
Monitoring of Clinical Investigations (PDF - 433 KB)  Final    Posted
                                                               3/2/1998
Nuclear Pharmacy Guideline Criteria for Determining   Final    Posted
 When to Register as a Drug Establishment (PDF - 3             3/2/1998
 MB)
Part 11, Electronic Records; Electronic Signatures--  Final    9/3/2003
 Scope and Application (PDF - 215 KB)
PAT--A Framework for Innovative Pharmaceutical        Final    9/29/2004
 Development, Manufacturing, and Quality Assurance
 (PDF - 315 KB)
PET Drug Products - Current Good Manufacturing        Final    9/15/2005
 Practice (CGMP) (PDF - 399 KB)
Pharmaceutical Components at Risk for Melamine        Final    8/6/2009
 Contamination (PDF - 137 KB)
Pharmacy Compounding--Compliance Policy Guide (PDF -  Final    5/2002
 793 KB)
Possible Dioxin/PCB Contamination of Drug and         Final    8/23/1999
 Biological Products (PDF - 8 KB)
Powder Blends and Finished Dosage Units--Stratified   Draft    11/2003
 In-Process Dosage Unit Sampling and Assessment (PDF
 - 297 KB)
   Revised Attachments (PDF - 159 KB)         .......  .........
Preparation of Investigational New Drug Products      Final    11/1992
 (Human and Animal)(PDF - 795 KB)
Prescription Drug Marketing Act--Donation of          Final    3/2006
 Prescription Drug Samples to Free Clinics (PDF - 38
 KB)
   Prescription Drug Marketing Act (PDMA)     .......  .........
   Requirements- Questions and Answers (PDF - 112
   KB) (Issued and Posted 11/13/2006)
Process Validation: General Principles and Practices  Draft    11/17/
 (PDF - 194 KB)                                                 2008
Quality Systems Approach to Pharmaceutical Current    Final    9/27/2006
 Good Manufacturing Practice Regulations (PDF - 443
 KB)
Questions and Answers on Current Good Manufacturing   Final    8/4/2004
 Practices (cGMP) for Drugs(updated 6/29/2009
Review of FDA's Implementation of the Drug Export     Final    11/1989
 Amendments of 1986 (PDF - 2 MB)
Sterile Drug Products Produced by Aseptic             Final    9/29/2004
 Processing--Current Good Manufacturing Practice
 (PDF - 734 KB)
Street Drug Alternatives (PDF - 11 KB)                Final    3/2000
Testing of Glycerin for Diethylene Glycol (PDF - 36   Final    5/1/2007
 KB)

[[Page 48197]]

The Use of Mechanical Calibration of Dissolution      Final    1/26/2010
 Apparatus 1 and 2--Current Good Manufacturing
 Practice (CGMP)(PDF - 38 KB)
Drug Safety
Conducting a Clinical Safety Review of a New Product  Final    2/2005
 Application and Preparing a Report on the Review
 (PDF - 1516 KB)
Drug-Induced Liver Injury: Premarketing Clinical      Final    7/29/2009
 Evaluation (PDF - 206 KB)
Drug Safety Information - FDA's Communication to the  Final    3/2/2007
 Public (PDF - 114 KB)
Format and Content of Proposed Risk Evaluation and    Draft    9/30/2009
 Mitigation Strategies (REMS), REMS Assessments, and
 Proposed REMS Modifications (PDF - 316 KB)
Postmarketing Studies and Clinical Trials--           Draft    7/15/2009
 Implementation of Section 505(o) of the Federal
 Food, Drug, and Cosmetic Act (PDF - 173 KB)
Electronic Submissions
Indexing Structured Product Labeling (PDF - 59 KB)    Final    6/2/2008
Part 11, Electronic Records; Electronic Signatures--  Final    9/3/2003
 Scope and Application (PDF - 215 KB)
Providing Regulatory Submissions in Electronic        Final    6/2002
 Format--ANDAs                                        Withdra
Withdrawn FR Notice 10/5/2006                          wn
                                                      FR
                                                       Notice
Providing Regulatory Submissions in Electronic        Draft    Posted
 Format -Annual Reports for NDAs and ANDAs            Withdra  8/27/2003
Withdrawn FR Notice 10/5/2006                          wn
                                                      FR
                                                       Notice
Providing Regulatory Submissions in Electronic        Final    4/20/2005
 Format--Content of Labeling (PDF - 28 KB)
Providing Regulatory Submissions in Electronic        Final    5/28/2009
 Format--Drug Establishment Registration and Drug
 Listing (PDF - 123 KB)
Providing Regulatory Submissions in Electronic        Final    Revised
 Format -Human Pharmaceutical Product Applications             06/11/
 and Related Submissions Using the eCTD                         2008
 Specifications(PDF - 133 KB)
 To ensure that you have the most recent versions of
 the specifications referenced in this document,
 check the appropriate center's Web page. CBER
 Topics page. CDER Topics page.
Providing Regulatory Submissions in Electronic        Draft    10/2003
 Format -General Considerations (PDF - 288 KB)
 (Issued, Posted 10/22/2003)
Providing Regulatory Submissions in Electronic        Draft    6/11/2008
 Format-Postmarketing Individual Case Safety Reports
 (PDF - 107 KB)
 To ensure that you have the most recent versions of
 the specifications referenced in this document,
 check the appropriate center's Web page. CBER
 Topics page. CDER Topics page.
Providing Regulatory Submissions in Electronic        Draft    1/2001
 Format - Prescription Drug Advertising and
 Promotional Labeling (PDF - 28 KB)
Providing Regulatory Submissions in Electronic        Draft    6/4/2007
 Format--Receipt Date (PDF - 59 KB)
Regulatory Submissions in Electronic Format; General  Final    1/1999
 Considerations (PDF - 54 KB)
Regulatory Submissions in Electronic Format; New      Final    1/1999
 Drug Applications                                    Withdra
Withdrawn FR Notice 10/5/2006                          wn
                                                      FR
                                                       Notice
SPL Standard for Content of Labeling Technical Qs &   Draft    10/2009
 As (PDF - 58 KB)
FDAAA (Food and Drug Administration Amendments Act)
Certifications To Accompany Drug, Biological          Draft    4/2008
 Product, and Device Applications/Submissions:
 Compliance with Section 4020) of The Public Health
 Service Act, Added By Title VIII of The Food and
 Drug Administration Amendments Act of 2007 (PDF -
 314 KB)
Generics
180-Day Exclusivity When Multiple ANDAs Are           Final    7/2003
 Submitted on the Same Day (PDF - 162 KB)
Alternate Source of the Active Pharmaceutical         Final    12/2000
 Ingredient in Pending ANDAs (PDF - 14 KB)
ANDAs: Impurities in Drug Products (PDF - 104 KB)     Draft    8/26/2005
ANDAs: Impurities in Drug Substances (PDF - 136 KB)   Final    7/15/2009
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry,   Final    7/6/2007
 Manufacturing, and Controls Information (PDF - 125
 KB)
Court Decisions, ANDA Approvals, and 180-Day          Final    3/2000
 Exclusivity Under the Hatch-Waxman Amendments to
 the Federal Food, Drug, and Cosmetic Act (PDF - 25
 KB)
Handling and Retention of Bioavailability and         Final    5/25/2004
 Bioequivalence Testing Samples (PDF - 166 KB)
Individual Product Bioequivalence Recommendations     Draft    5/30/2007
 (PDF - 45 KB)
List of Product Bioequivalence Recommendations
Letter announcing that the OGD will now accept the    Final    8/1995
 ICH long-term storage conditions as well as the
 stability studies conducted in the past. (PDF - 194
 KB)
Letter describing efforts by the CDER and the ORA to  Final    10/1994
 clarify the responsibilities of CDER chemistry
 review scientists and ORA field investigators in
 the new and abbreviated drug approval process in
 order to reduce duplication or redundancy in the
 process (PDF - 274 KB)
Letter on incomplete Abbreviated Applications,        Final    4/1994
 Convictions Under GDEA, Multiple Supplements,
 Annual Reports for Bulk Antibiotics, Batch Size for
 Transdermal Drugs, Bioequivalence Protocols,
 Research, Deviations from OGD Policy (PDF - 1915
 KB)
Letter on the Provision of new information            Final    7/1992
 pertaining to new bioequivalence guidelines and
 refuse-to-file letters (PDF - 254 KB)
Letter on the provision of new procedures and         Final    3/1989
 policies affecting the generic drug review process
 (PDF - 608 KB)
Letter on the request for cooperation of regulated    Final    11/1990
 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 (PDF -
 917 KB)
Letter on the response to 12/20/1984 letter from the  Final    3/1985
 Pharmaceutical Manufacturers Association about the
 Drug Price Competition and Patent Term Restoration
 Act(PDF - 392 KB)

[[Page 48198]]

Letter to all ANDA and AADA applicants about the      Final    1/1993
 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 (PDF - 233 KB)
Letter to regulated industry notifying interested     Final    8/1993
 parties about important detailed information
 regarding labeling, scale-up, packaging, minor/
 major amendment criteria and bioequivalence
 requirements (PDF - 908 KB)
Listed Drugs, 30-Month Stays, and Approval of ANDAs   Draft    10/2004
 and 505(b)(2) Applications Under Hatch-Waxman, as
 Amended by the Medicare Prescription Drug,
 Improvement, and Modernization Act of 2003--
 Questions and Answers (PDF - 57 KB)
Major, Minor, and Telephone Amendments to             Final    12/2001
 Abbreviated New Drug Applications (PDF - 24 KB)
Potassium Chloride Modified-Release Tablets and       Final    10/25/
 Capsules: In Vivo Bioequivalence and In Vitro                  2005
 Dissolution Testing (PDF - 48 KB)
Revising ANDA Labeling Following Revision of the RLD  Final    4/26/2000
 Labeling (PDF - 19 KB)
Submission of Summary Bioequivalence Data for         Draft    4/16/2009
 Abbreviated New Drug Applications (PDF - 183 KB)
Variations in Drug Products that May Be Included in   Final    12/1998
 a Single ANDA (PDF - 107 KB)
Good Review Practices
Conducting a Clinical Safety Review of a New Product  Final    2/2005
 Application and Preparing a Report on the Review
 (PDF - 1516 KB)
Guidance for Sponsors, Industry, Researchers,         Final    1/21/2009
 Investigators, and Food and Drug Administration
 Staff : Certifications To Accompany Drug,
 Biological Product, and Device Applications/
 Submissions: Compliance with Section 402(j) of The
 Public Health Service Act, Added By Title VIII of
 The Food and Drug Administration Amendments Act of
 2007
Pharmacology/Toxicology Review Format (PDF - 55 KB)   Final    5/2001
International Conference on Harmonisation - Efficacy
E1A The Extent of Population Exposure to Assess       Final    3/1995
 Clinical Safety: For Drugs Intended for Long-term
 Treatment of Non-Life-Threatening Conditions (PDF -
 17 KB)
E2A Clinical Safety Data Management: Definitions and  Final    3/1995
 Standards for Expedited Reporting (PDF - 49 KB)
E2B International Conference on Harmonisation;        Final    1/15/1998
 Guidance on Data Elements for Transmission of
 Individual Case Safety Reports (PDF - 69 KB)
   E2BM Data Elements for Transmission Of     .......  .........
   Individual Case Safety Reports (PDF - 74 KB)
   (Issued 4/2002, Posted 4/4/2002)
    [cir] E2B(M) Questions and Answers (PDF - 55 KB)  .......  .........
     (Revised 3/09/2005, Posted, 3/16/2005)
E2B(R) Clinical Safety Data Management: Data          Draft    9/30/2005
 Elements for Transmission of Individual Case Safety
 Reports (PDF - 269 KB) (Issued , Posted 9/30/2005)
E2C(R1) Clinical Safety Data Management: Periodic     .......  .........
 Safety Update Reports for Marketed Drugs
 Note: In November 2005, the ICH incorporated the
 E2C addendum with the E2C parent guidance and
 retitled the combined document E2C(R1). The
 contents of the two guidances were not revised.
   E2C Clinical Safety Data Management:       Final    5/19/1997
   Periodic Safety Update Reports for Marketed Drugs
   (PDF - 169 KB)
   E2C Addendum to ICH E2C Clinical Safety    Final    2/5/2004
   Data Management: Periodic Safety Update Reports
   for Marketed Drugs (PDF - 35 KB)
E2D Postapproval Safety Data Management: Definitions  Draft    9/12/2003
 and Standards for Expedited Reporting (PDF - 184
 KB)
E2E Pharmacovigilance Planning (PDF - 73 KB)          Final    3/31/05
E2F Development Safety Update Report (PDF - 118 KB)   Draft    8/4/2008
E3 Structure and Content of Clinical Study Reports    Final    7/1996
 (PDF - 240 KB)
E4 Dose-Response Information to Support Drug          Final    7/1996
 Registration (PDF - 49 KB)
E5 Ethnic Factors in the Acceptability of Foreign     .......  .........
 Clinical Data
   E5 Questions and Answers (PDF - 48 KB)     Final    6/2004
   [Issued 9/27/2006; Posted 9/28/2006]
E6 Good Clinical Practice: Consolidated Guideline     Final    5/9/1997
 (PDF - 262 KB)
Spanish Version (PDF - 151 kb)
E7 Studies in Support of Special Populations:         Final    8/1994
 Geriatrics (PDF - 25 KB)
E7 Studies in Support of Special Populations;         Draft    11/9/2009
 Geriatrics; Questions and Answers (PDF - 125 KB)
E8 General Considerations for Clinical Trials (PDF -  Final    12/1997
 67 KB)
E9 Statistical Principles for Clinical Trials (PDF -  Final    9/1/1998
 110 KB)
E10 Choice of Control Group and Related Issues in     Final    5/2001
 Clinical Trials (PDF - 93 KB)
E11 Clinical Investigation of Medicinal Products in   Final    12/2000
 the Pediatric Population (PDF - 60 KB)
E12A Principles for Clinical Evaluation of New        Draft    8/2000
 Antihypertensive Drugs. (PDF - 27 KB)
E14 Clinical Evaluation of QT/QTc Interval            Final    10/19/
 Prolongation and Proarrhythmic Potential for Non-              2005
 Antiarrhythmic Drugs (PDF - 67 KB)
Questions and Answers (PDF - 108 KB)                  .......  11/18/
                                                                2008
E15 Pharmacogenomics Definitions and Sample Coding    Final    4/7/2008
 (PDF - 90 KB)
E16 Genomic Biomarkers Related to Drug Response:      Draft    7/30/2009
 Context, Structure, and Format of Qualification
 Submissions (PDF - 135 KB)
International Conference on Harmonisation - Joint Safety/Efficacy
 (Multidisciplinary)
M2 eCTD: Electronic Common Technical Document         Final    4/1/2003
 Specification (PDF - 1,020 KB)
   M2: eCTD Specification Questions and       .......  3/14/05
   Answers and Change Requests (PDF 17 KB)
   Companion Document: Current Q & As and     .......  7/10/2008
   Change Requests
M3(R2) Nonclinical Safety Studies for the Conduct of  Final    1/20/2010
 Human Clinical Trials and Marketing Authorization
 for Pharmaceuticals (PDF - 295 KB)
M4: Common Technical Document for the Registration    Final    Originall
 of Pharmaceuticals for Human Use                               y
                                                               Issued
                                                               10/15/
                                                                2001
   M4: Organization of the CTD (PDF - 31 KB)  .......  .........

[[Page 48199]]

   M4 Granularity Annex (PDF - 124 KB)        .......  .........
   (Issued 10/18/2005, Posted 10/18/2005)
   M4: The CTD--General Questions and         .......  .........
   Answers (PDF - 29 KB) (Issued 12/04, Posted 12/22/
   2004)
   M4: The CTD--Quality (PDF - 79 KB)         .......  .........
   M4: The CTD--Quality Questions and         .......  .........
   Answers /Location Issues (PDF - 49 KB) (Issued 6/
   2004, Posted 6/8/2004)
   M4: The CTD--Efficacy (PDF - 156 KB)       .......  .........
   M4: The CTD--Efficacy Questions and        .......  .........
   Answers (PDF - 34 KB) (Issued 12/2004, Posted 12/
   22/2004)
   Clarification for Q&A 10 on submitting integrated
   summaries of safety and effectiveness (ISS/ISE)
   in the eCTD format [esrs/eCTD page].
   M4: The CTD--Safety (PDF - 60 KB)          .......  .........
   M4: The CTD--Safety Appendices (PDF - 178  .......  .........
   KB)
    [cir] M4: The CTD--Safety Questions and Answers   .......  .........
     (PDF - 16 KB) (Issued 2/2003, Posted 2/4/2003)
M5 International Conference on Harmonisation; Draft   Draft    9/2005
 Guidance on M5 Data Elements and Standards for Drug
 Dictionaries (PDF - 288 KB)
Submitting Marketing Applications According to the    Draft    9/2001
 ICH/CTD Format: General Considerations (PDF - 50
 KB)
International Conference on Harmonisation - Quality
Q1A(R2) Stability Testing of New Drug Substances and  Final    11/2003
 Products (PDF - 58 KB)
Q1B Photostability Testing of New Drug Substances     Final    11/1996
 and Products (PDF - 339 KB)
Q1C Stability Testing for New Dosage Forms (PDF -     Final    5/9/1997
 101 KB)
Q1D Bracketing and Matrixing Designs for Stability    Final    1/2003
 Testing of New Drug Substances and Products (PDF -
 31 KB)
Q1E Evaluation of Stability Data (PDF - 221 KB)       Final    6/2004
Q1F Stability Data Package for Registration           Final    Withdrawn
 Applications in Climatic Zones III and IV, revision           7/6/2006
 1
Q2(R1) Validation of Analytical Procedures: Text and  .......  .........
 Methodology
 Note: In November 2005, the ICH incorporated Q2B on
 methodology with the parent guidance Q2A and
 retitled the combined Q2 document. The contents of
 the two guidances were not revised.
   Q2A Text on Validation of Analytical       Final    3/1995
   Procedures (PDF - 25 KB)
   Q2B Validation of Analytical Procedures:   Final    5/19/1997
   Methodology (PDF - 132 KB)
Q3A(R) Impurities in New Drug Substances (PDF - 55    Final    6/6/2008
 KB)
Q3B(R) Impurities in New Drug Products (Revision      Final    8/4/2006
 2)(PDF - 171 KB)
Q3C Impurities: Residual Solvents (PDF - 41 KB)       Final    12/24/
                                                                1997
Q3C Tables and List (PDF - 33 KB)                     Final    11/12/
                                                                2003
   Appendix 4 (PDF - 120 KB); Appendix 5      Final    2/11/2002
   (PDF - 216 KB); Appendix 6 (PDF - 128 KB)
   (Appendices were issued with the Q3C draft
   guidance documents)
   Maintenance Procedures for Updating
Q4B Evaluation and Recommendation of Pharmacopoeial   Final    2/20/2007
 Texts for Use in the International Conference on
 Harmonisation Regions (PDF - 55 KB)
   Annex I: Residue on Ignition/Sulphated     Final    2/20/2007
   Ash General Chapter (PDF - 36 KB)
   Annex 2: Test for Extractable Volume of    Final    1/8/2009
   Parenteral Preparations General Chapter (PDF - 79
   KB)
   Annex 3: Test for Particulate              Final    1/8/2009
   Contamination: Subvisible Particles General
   Chapter (PDF - 1208 KB)
   Annex 4A: Microbiological Examination of   Final    4/7/2009
   Non-Sterile Products: Microbial Enumeration Tests
   General Chapter (PDF - 81 KB)
   Annex 4B: Microbiological Examination of   .......  .........
   Non-Sterile Products: Tests for Specified Micro-
   organisms General Chapter (PDF - 82 KB)
   Annex 4C: Microbiological Examination of   .......  .........
   Non-Sterile Products: Acceptance Criteria for
   Pharmaceutical Preparations and Substances for
   Pharmaceutical Use General Chapter (PDF - 75 KB)
   Annex 5: Disintegration Test General       Final    12/22/
   Chapter (PDF - 32 KB)                                        2009
   Annex 6:Uniformity of Dosage Units         Final    4/2/2010
   General Chapter (PDF - 87 KB)
   Annex 7:Dissolution Test General Chapter
   (PDF - 93 KB)
   Annex 8: Sterility Test General Chapter    Final    12/22/
   (PDF - 32 KB)                                                2009
   Annex 9: Tablet Friability General         Final    4/2/2010
   Chapter (PDF - 84 KB)
   Annex 10: Polyacrylamide Gel               Final    4/9/2010
   Electrophoresis General Chapter (PDF - 84 KB)
   Annex 11: Capillary Electrophoresis        .......  .........
   General Chapter (PDF - 90 KB)
   Annex 12: Analytical Sieving General       Draft    12/16/
   Chapter (PDF - 313 KB)                                       2009
Q5A Viral Safety Evaluation of Biotechnology          Final    Posted
 Products Derived From Cell Lines of Human or Animal           9/1998
 Origin (PDF - 71 KB)
Q5B Quality of Biotechnological Products: Analysis    Final    2/1996
 of the Expression Construct in Cells Used for
 Production of r-DNA Derived Protein Products (PDF -
 109 KB)
Q5C Quality of Biotechnological Products: Stability   Final    7/1996
 Testing of Biotechnological/Biological Products
 (PDF - 70 KB)
Q5D Quality of Biotechnological/Biological Products:  Final    9/21/1998
 Derivation and Characterization of Cell Substrates
 Used for Production of Biotechnological/Biological
 Products; Availability (PDF - 52 KB)34 (Issued ,
 Posted 9/21/1998)
Q5E Comparability of Biotechnological/Biological      Final    6/2005
 Products Subject to Changes in Their Manufacturing
 Process (PDF - 58 KB)
Q6A International Conference on Harmonisation;        Final    12/29/
 Guidance on Q6A Specifications: Test Procedures and            2000
 Acceptance Criteria for New Drug Substances and New
 Drug Products: Chemical Substances.
Q6B Specifications: Test Procedures and Acceptance    Final    8/1999
 Criteria for Biotechnological/Biological Products
 (PDF - 64 KB)
Q7A Good Manufacturing Practice Guidance for Active   Final    8/2001
 Pharmaceutical Ingredients (PDF - 175 KB)
Note: In November 2005, the ICH redesignated this
 guidance. Q7 The guidance was not revised.
Q8(R2) Pharmaceutical Development (PDF - 402 KB)      Final    11/20/
                                                                2009

[[Page 48200]]

Q9 Quality Risk Management (PDF - 113 KB)             Final    6/1/2006
Q10 Pharmaceutical Quality System (PDF - 274 KB)      Final    4/7/2009
International Conference on Harmonisation - Safety
S1A The Need for Long-term Rodent Carcinogenicity     Final    3/1996
 Studies of Pharmaceuticals (PDF - 100 KB)
S1B Testing for Carcinogenicity of Pharmaceuticals    Final    2/28/1998
 (PDF - 145 KB)
S1C(R2) Dose Selection for Carcinogenicity Studies    Final    9/17/2008
 of Pharmaceuticals (PDF - 185 KB)
S2A Specific Aspects of Regulatory Genotoxicity       Final    4/1996
 Tests for Pharmaceuticals (PDF - 123 KB)
S2B Genotoxicity: A Standard Battery for              Final    11/21/
 Genotoxicity Testing of Pharmaceuticals (PDF - 131             1997
 KB)
S2(R1) Genotoxicity Testing and Data Interpretation   Draft    3/24/2008
 for Pharmaceuticals Intended for Human Use(PDF -
 242 KB)
S3A Toxicokinetics: The Assessment of Systemic        Final    3/1995
 Exposure in Toxicity Studies (PDF - 46 KB)
S3B Pharmacokinetics: Guidance for Repeated Dose      Final    3/1995
 Tissue Distribution Studies (PDF - 14 KB)
S4A Duration of Chronic Toxicity Testing in Animals   Final    Posted
 (Rodent and Nonrodent Toxicity Testing)(PDF - 21              6/25/99
 KB)
S5(R2) Detection of Toxicity to Reproduction for      .......  .........
 Medicinal Products Toxicity to Male Fertility
 Note: In November 2005, the ICH incorporated the
 S5B addendum with S5A and retitled the combined S5
 document. The contents of the two guidances were
 not revised.
   S5A Detection of Toxicity to Reproduction  Final    9/1994
   for Medicinal Products (PDF - 87 KB)
   S5B Detection of Toxicity to Reproduction  Final    4/1996
   for Medicinal Products: Addendum on Toxicity to
   Male Fertility (PDF - 98 KB)
S6 Preclinical Safety Evaluation of Biotechnology-    Final    11/1997
 Derived Pharmaceuticals (PDF - 137 KB)
   Addendum to ICH S6:(PDF - 160 KB)          Draft    12/16/
   Preclinical Safety Evaluation of Biotechnology -             2009
   Derived Pharmaceuticals S6(R1)
S7A Safety Pharmacology Studies for Human             Final    7/2001
 Pharmaceuticals (PDF - 44 KB)
S7B Nonclinical Evaluation of the Potential for       Final    10/19/
 Delayed Ventricular Repolarization (QT Interval                2005
 Prolongation) by Human Pharmaceuticals (PDF - 52
 KB)
S8 Immunotoxicity Studies for Human Pharmaceuticals   Final    4/12/2006
 (PDF - 72 KB)
S9 Nonclinical Evaluation for Anticancer              Final    3/5/2010
 Pharmaceuticals (PDF - 170 KB)
Investigational New Drug Applications
Content and Format of Investigational New Drug        Final    11/1995
 Applications (INDs) for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-derived Products (PDF - 42 KB)
   Questions and Answers: Content and Format  .......  .........
   of INDs for Phase 1 Studies of Drugs, Including
   Well-Characterized, Therapeutic, Biotechnology-
   Derived Products (PDF - 14 KB) (10/2000)
Exploratory IND Studies (PDF - 220 KB)                Final    1/12/2006
Labeling
Adverse Reactions Section of Labeling for Human       Final    1/18/2006
 Prescription Drug and Biological Products--Content
 and Format (PDF - 52 KB)
Clinical Pharmacology Section of Labeling for Human   Draft    3/3/2009
 Prescription Drug and Biological Products--Content
 and Format (PDF - 144 KB)
Clinical Studies Section of Labeling for Human        Final    1/18/2006
 Prescription Drug and Biological Products--Content
 and Format(PDF - 127 KB)
Content and Format for Geriatric Labeling (PDF - 38   Final    10/2001
 KB)
Contents of a Complete Submission for the Evaluation  Final    2/5/2010
 of Proprietary Names (PDF - 306 KB)
Dosage and Administration Section of Labeling for     Final    3/22/2010
 Human Prescription Drug and Biological Products -
 Content and Format (PDF - 143 KB)
Hypertension Indication: Drug Labeling for            Draft    3/12/2008
 Cardiovascular Outcome Claims (PDF - 53 KB)
Labeling for Combined Oral Contraceptives (PDF - 92   Draft    3/2/2004
 KB)
Labeling for Human Prescription Drugs--Determining    Final    10/16/
 Established Pharmacologic Class for Use in the                 2009
 Highlights of Prescribing Information (PDF - 66 KB)
Labeling for Human Prescription Drug and Biological   Draft    1/18/2006
 Products--Implementing the New Content and Format
 Requirements (PDF - 213 KB)
Labeling Guidance for OTC Topical Drug Products for   Draft    6/1998
 the Treatment of Vaginal Yeast Infections
 (Vulvovaginal Candidiasis) (PDF - 71 KB)
Noncontraceptive Estrogen Drug Products for the       Draft    11/15/
 Treatment of Vasomotor Symptoms and Vulvar and                 2005
 Vaginal Atrophy Symptoms--Recommended Prescribing
 Informtion for Health Care Providers and Patient
 Labeling (PDF - 458 KB)
Public Availability of Labeling Changes in ``Changes  Draft    9/19/2006
 Being Effected'' Supplements (PDF - 26 KB)
Referencing Discontinued Labeling for Listed Drugs    Draft    10/26/
 in Abbreviated New Drug Applications (PDF - 32 KB)             2000
Updating Labeling for Susceptibility Test             Final    6/26/2009
 Information in Systemic Antibacterial Drug Products
 and Antimicrobial Susceptibility Testing Devices
 (PDF - 188 KB)
Warnings and Precautions, Contraindications, and      Draft    1/18/2006
 Boxed Warning Sections of Labeling for Human
 Prescription Drug and Biological Products--Content
 and Format (PDF - 58 KB)
Microbiology
Format and Content of the Microbiology Section of an  Final    1990
 Application* (PDF - 546 KB)
Modernization Act
Changes to an Approved NDA or ANDA (PDF - 108 KB)     Final    4/2004
Classifying Resubmissions in Response to Action       Final    5/14/1998
 Letters (PDF - 76 KB)
Enforcement Policy During Implementation of Section   Final    Withdrawn
 503A of the Federal Food, Drug, and Cosmetic Act              9/2008
Fast Track Drug Development Programs - Designation,   Final    11/17/
 Development, and Application Review (PDF - 311 KB)             1998
 (Posted 7/22/2004)
 Appendix 2 [(PDF - 3930 KB)] [Appendices are
 scanned copies, which will be replaced by final
 versions]
Formal Dispute Resolution: Appeals Above the          Final    2/2000
 Division Level(PDF - 30 KB)
Formal Meetings With Sponsors and Applicants for      Final    5/19/2009
 PDUFA Products (PDF - 89 KB)

[[Page 48201]]

Implementation of Section 120 of the Food and Drug    Final    10/1998
 Administration Modernization Act of 1997-Advisory
 Committees (PDF - 62 KB)
Implementation of Section 126 of the Food and Drug    Final    7/1998
 Administration Modernization Act of 1997 -
 Elimination of Certain Labeling Requirements (PDF -
 979 KB)
Information Program on Clinical Trials for Serious    Final    3/2002
 or Life-Threatening Diseases and Conditions(PDF -
 34 KB)
Information Program on Clinical Trials for Serious    Draft    1/2004
 or Life-Threatening Diseases and Conditions (PDF -
 40 KB)
National Uniformity for Nonpresciption Drugs -        Final    4/1998
 Ingredient Listing for OTC Drugs (PDF - 74 KB)
PET Drug Applications - Content and Format for NDAs   Draft    3/7/2000
 and ANDAs (PDF - 153 KB)
   Sample formats for chemistry,              .......  .........
   manufacturing, and controls sections (PDF - 125
   KB)
   Sample formats for labeling (PDF - 94 KB)  .......  .........
   Sample formats for Form FDA 356h (PDF -    .......  .........
   51 KB)
   Sample formats for user fee Form FDA       .......  .........
   3397(PDF - 42 KB)
Providing Clinical Evidence of Effectiveness for      Final    5/14/1998
 Human Drug and Biological Products (PDF - 129 KB)
Qualifying for Pediatric Exclusivity Under Section    Final    9/1999
 505A of the Federal Food, Drug, and Cosmetic Act
 (PDF - 57 KB)
   Frequently Asked Questions on Pediatric    .......  Posted
   Exclusivity (505A), The Pediatric ``Rule,'' and             7/27/1999
   Their Interaction
Repeal of Section 507 of the Federal Food, Drug and   Final    Revised
 Cosmetic Act (PDF - 85 KB)                                    5/1998
Reports on the Status of Postmarketing Study          Final    2/15/2006
 Commitments--Implementation of Section 130 of the
 Food and Drug Administration Modernization Act of
 1997 (PDF - 456 KB)
Standards for Prompt Review of Efficacy Supplements   Final    5/15/1998
 (PDF - 76 KB)
Submission of Abbreviated Reports and Synopses in     Final    8/1998
 Support of Marketing Applications (PDF - 43 KB)
Submitting and Reviewing Complete Responses to        Final    10/2000
 Clinical Holds (Revised) (PDF - 26 KB)
Over-the-Counter
Enforcement Policy on Marketing OTC Combination       Final    5/1984
 Products (CPG 7132b.16)(PDF - 294 KB)
General Guidelines for OTC Combination Products (PDF  Final    11/1978
 - 270 KB)
Label Comprehension Studies for Nonprescription Drug  Draft    4/30/2009
 Products (PDF - 204 KB)
Labeling Guidance for OTC Topical Drug Products for   Draft    6/1998
 the Treatment of Vaginal Yeast Infections
 (Vulvovaginal Candidiasis) (PDF - 71 KB)
Labeling OTC Human Drug Products--Questions and       Final    1/2/2009
 Answers (PDF - 599 KB)
Labeling OTC Human Drug Products -Submitting          Draft    12/2000
 Requests for Exemptions and Deferrals (PDF - 34 KB)
Labeling OTC Human Drug Products; Small Entity        Final    5/12/2009
 Compliance Guide (PDF - 270 KB)
Labeling OTC Human Drug Products Updating Labeling    Draft    2/21/2001
 in ANDAs (PDF - 32 KB)
   Additional examples 1 (PDF - 32 KB) (3/19/ .......  .........
   2001)
   Additional examples 2 (PDF - 15 KB) (3/26/ .......  .........
   2001)
   Additional examples 3 (PDF - 17 KB) (3/26/ .......  .........
   2001)
Labeling OTC Human Drug Products Updating Labeling    Final    10/2002
 in RLDs and ANDAs (PDF - 30 KB)
Example Drug Facts Labels
   Acetaminophen 120 mg in a Suppository      .......  .........
   Dosage Form (PDF - 13 KB)
   Acetaminophen 325 mg in a Suppository      .......  .........
   Dosage Form (PDF - 14 KB)
   Acetaminophen 650 mg in a Suppository      .......  .........
   Dosage Form (PDF - 14 KB)
   Cimetidine 200 mg in a Tablet Dosage Form  .......  .........
   (PDF - 13 KB)
   Clemastine Fumerate 1.34 mg in a Tablet    .......  .........
   Dosage Form(PDF - 14 KB)
   Doxylamine Succinate 25 mg Tablet Dosage   .......  .........
   Form (PDF - 12 KB)
   Ibuprofen 200 mg in a Tablet/Capsule       .......  .........
   Dosage Form (PDF - 14 KB)
   Loperamide HCl in a Liquid Dosage Form     .......  .........
   (PDF - 15 KB)
   Loperamide HCl in a Tablet/Caplet Dosage   .......  .........
   Form (PDF - 15 KB)
   Miconazole Nitrate Vaginal Products (PDF - .......  .........
    16 KB)
   Minoxidil Topical Solution 2% for Men and  .......  .........
   Women (PDF - 14 KB)
   Minoxidil Topical Solution 5% for Men      .......  .........
   (PDF - 17 KB)
   Naproxen Sodium 220 mg in a Tablet/Caplet/ .......  .........
   Gelcap Dosage Form (PDF - 14 KB)
   Pseudoephedrine HCl Extended-Release       .......  .........
   Tablets 120 mg (PDF - 15 KB)
Labeling OTC Human Drug Products Using a Column       Final    12/2000
 Format (PDF - 57 KB)
Labeling OTC Skin Protectant Drug Products (PDF -     Draft    Removed
 274 KB)                                                       3/18/2010
Postmarketing Adverse Event Reporting for             Final    7/13/2009
 Nonprescription Human Drug Products Marketed
 Without an Approved Application (PDF - 298 KB)
Labeling of Nonprescription Human Drug Products       Final    8/31/2009
 Marketed Without an Approved Application as
 Required by the Dietary Supplement and
 Nonprescription Drug Consumer Protection Act:
 Questions and Answers (PDF - 83 KB)
Time and Extent Applications (PDF - 46 KB)            Draft    2/2004
Upgrading Category III Antiperspirants to Category I  Final    10/1978
 (43 FR 46728-46731) (PDF - 583 KB)
Pharmacology/Toxicology
Animal Models--Essential Elements to Address          Draft    1/16/2009
 Efficacy Under the Animal Rule (PDF - 135 KB)
Carcinogenicity Study Protocol Submissions (PDF - 29  Final    5/22/2002
 KB)
Content and Format of Investigational New Drug        Final    11/1995
 Applications (INDs) for Phase 1 Studies of Drugs,
 Including Well-Characterized, Therapeutic,
 Biotechnology-derived Products (PDF - 42 KB)
   Questions and Answers: Content and Format  .......  .........
   of INDs for Phase 1 Studies of Drugs, Including
   Well-Characterized, Therapeutic, Biotechnology-
   Derived Products (PDF - 14 KB) (10/2000)
Developing Medical Imaging Drug and Biological        Final    6/17/2004
 Products
   Part 1: Conducting Safety Assessments      .......  .........
   (PDF - 271 KB)

[[Page 48202]]

Estimating the Maximum Safe Starting Dose in Initial  Final    7/21/2005
 Clinical Trials for Therapeutics in Adult Healthy
 Volunteers (PDF - 702 KB)
Exploratory IND Studies (PDF - 220 KB)                Final    1/12/2006
Format and Content of the Nonclinical Pharmacology/   Final    2/1987
 Toxicology Section of an Application* (PDF -1300
 KB)
Genotoxic and Carcinogenic Impurities in Drug         Draft    12/15/
 Substances and Products: Recommended Approaches                2008
 (PDF - 169 KB)
Immunotoxicology Evaluation of Investigational New    Final    10/2002
 Drugs (PDF - 100 KB)
Integration of Study Results to Assess Concerns       Draft    11/2001
 about Human Reproductive and Developmental
 Toxicities (PDF - 142 KB) (Issued , Posted 11/9/
 2001)
Nonclinical Evaluation of Late Radiation Toxicity of  Draft    6/17/2005
 Therapeutic Radiopharmaceuticals (PDF - 233 KB)
Nonclinical Pharmacology/Toxicology Development of    Final    10/96
 Topical Drugs Intended to Prevent the Transmission            Updated
 of Sexually Transmitted Diseases (STD) and/or for             7/2005
 the Development of Drugs Intended to Act as Vaginal
 Contraceptives
Nonclinical Safety Evaluation of Drug or Biologic     Final    3/14/2006
 Combinations (PDF - 100 KB)
Nonclinical Safety Evaluation of Reformulated Drug    Draft    3/7/2008
 Products and Products Intended for Administration
 by an Alternate Route (PDF - 76 KB)
Nonclinical Safety Evaluation of Pediatric Drug       Final    2/14/2006
 Products (PDF - 479 KB)
Nonclinical Studies for the Safety Evaluation of      Final    05/18/
 Pharmaceutical Excipients(PDF - 230 KB)                        2005
Photosafety Testing (PDF - 179 KB)                    Final    5/7/2003
Recommended Approaches to Integration of Genetic      Final    1/3/2006
 Toxicology Study Results (PDF - 190 KB)
Reference Guide for the Nonclinical Toxicity Studies  Final    3/2/1998
 of Antivial Drugs Indicated for the Treatment of N/
 A Non-Life Threatening Disease Evaluation of Drug
 Toxicity Prior to Phase I Clinical Studies (PDF -
 837 KB)
Safety Testing of Drug Metabolites (PDF - 86 KB)      Final    2/14/2008
Single Dose Acute Toxicity Testing for                Final    8/1996
 Pharmaceuticals (PDF - 63 KB)
Statistical Aspects of the Design, Analysis, and      Draft    5/2001
 Interpretation of Chronic Rodent Carcinogenicity
 Studies of Pharmaceuticals (PDF - 135 KB)
Procedural
180-Day Generic Drug Exclusivity Under the Hatch-     Final    6/1998
 Waxman Amendments to the Federal Food, Drug, and
 Cosmetic Act (PDF - 77 KB)
Applications Covered by Section 505(b)(2)(PDF - 41    Draft    10/1999
 KB)
Citizen Petitions and Petitions for Stay of Action    Draft    1/16/2009
 Subject to Section 505(q) of the Federal Food,
 Drug, and Cosmetic Act (PDF - 164 KB)
Complementary and Alternative Medicine Products and   Draft    12/2006
 Their Regulation by the Food and Drug Administation
Container and Closure System Integrity Testing in     Final    2/22/2008
 Lieu of Sterility Testing as a Component of the
 Stability Protocol for Sterile Products (PDF - 64
 KB)
Continuous Marketing Applications: Pilot 1--          Final    Withdrawn
 Reviewable Units for Fast Track Products Under                4/9/2010
 PDUFA (PDF - 195 KB)
Continuous Marketing Applications: Pilot 2--          Final    Withdrawn
 Scientific Feedback and Interactions During                   4/9/2010
 Development of Fast Track Products Under PDUFA (PDF
 - 168 KB)
   Paperwork Reduction Act Burden Statement   .......  .........
   (PDF - 72 KB) (Posted 7/27/2004)
Cooperative Manufacturing Arrangements for Licensed   Final    12/3/2008
 Biologics
Court Decisions, ANDA Approvals, and 180-Day          Final    Posted
 Exclusivity Under the Hatch-Waxman Amendments to              3/27/2000
 the Federal Food, Drug, and Cosmetic Act (PDF - 25
 KB)
Disclosing Information Provided to Advisory           Draft    12/1999
 Committees in Connection with Open Advisory
 Committee Meetings Related to the Testing or
 Approval of New Drugs and Convened by the Center
 for Drug Evaluation and Research, Beginning on
 January 1, 2000 (PDF - 30 KB)
Disclosure of Conflicts of Interest for Special       Draft    2/14/2002
 Government Employees Participating in FDA Product
 Specific Advisory Committees
Disclosure of Materials Provided to Advisory          Final    11/1999
 Committees in Connection with Open Advisory
 Committee Meetings Convened by the Center for Drug
 Evaluation and Research Beginning on January 1,
 2000 (PDF - 10 KB)
Drug Products Containing Ensulizole, Hypromellose,    Final    6/3/2003
 Meradimate, Octinoxate, and Octisalate--Labeling
 Enforcement Policy (PDF - 159 KB)
Emergency Use Authorization of Medical Products;      Draft    7/5/2005
 Availability (PDF - 4070 KB)
End-of-Phase 2A Meetings (PDF - 163 KB)               Final    9/18/2009
Enforcement Policy During Implementation of Section   Withdra  9/2008
 503A of the Federal Food, Drug, and Cosmetic Act      wn
Fast Track Drug Development Programs - Designation,   Final    1/12/2006
 Development, and Application Review (PDF - 83 KB)
 Appendix 2 (PDF - 3930 KB)15 [Appendices are
 scanned copies, which will be replaced by final
 versions] (Issued 11/17/1998, Posted 11/17/1998)
FDA Export Certificates                               Final    7/2004
Financial Disclosure by Clinical Investigators        Final    3/27/2001
Fixed Dose Combinations, Co-Packaged Drug Products,   Final    10/17/
 and Single-Entity Versions of Previously Approved              2006
 Antiretrovirals for the Treatment of HIV (PDF - 343
 KB)
Formal Dispute Resolution: Appeals Above the          Final    2/2000
 Division Level (PDF - 30 KB)
Formal Meetings Between the FDA and Sponsors or       Final    5/19/2009
 Applicants (PDF - 89 KB)
Forms for Registration of Producers of Drugs and      Draft    5/14/2001
 Listing of Drugs in Commercial Distribution (PDF -
 32 KB)
Good Reprint Practices for the Distribution of        Final    1/14/2009
 Medical Journal Articles and Medical or Scientific
 Reference Publications on Unapproved New Uses of
 Approved Drugs and Approved or Cleared Medical
 Devices U.S.
Good Review Management Principles and Practices for   Final    3/2005
 PDUFA Products (PDF - 683 KB)

[[Page 48203]]

Guidance for FDA Staff: The Leveraging Handbook; An   Final    Revised
 Agency Resource for Effective Collaborations (PDF -           6/2003
 143 KB)
Guidance for Clinical Investigators, Sponsors, and    Final    1/14/2009
 IRBs Adverse Event Reporting to IRBs--Improving
 Human Subject Protection (PDF - 61 KB)
Guidance to Pharmacies: Compounding Tamiflu Oral      Draft    1/11/2010
 Suspension in Advance to Provide for Multiple
 Prescriptions (PDF - 114KB)
Guidance for Sponsors, Clinical Investigators, and    Draft    12/2/2008
 IRBs; Data Retention When Subjects Withdraw From
 FDA-Regulated Clinical Trials (PDF - 399 KB)
How to Comply with the Pediatric Research Equity Act  Draft    9/7/2005
 (PDF - 116 KB)
Implementation of Section 120 of the Food and Drug    Final    10/1998
 Administration Modernization Act of 1997-Advisory
 Committees (PDF - 62 KB)
Implementation of Section 126 of the Food and Drug    Final    7/1998
 Administration Modernization Act of 1997 -
 Elimination of Certain Labeling Requirements (PDF -
 979 KB)
Independent Consultants for Biotechnology Clinical    Final    8/18/2004
 Trial Protocols
Information Program on Clinical Trials for Serious    Draft    1/2004
 or Life-Threatening Diseases and Conditions (PDF -
 40 KB) [Revision 1]
Information Program on Clinical Trials for Serious    Final    3/2002
 or Life-Threatening Diseases and Conditions (PDF -
 34 KB)
Information Request and Discipline Review Letters     Final    11/2001
 Under the Prescription Drug User Fee Act (PDF - 27
 KB)
Information Sheet Guidance for Sponsors, Clinical     Draft    7/29/2008
 Investigators, and IRBs Frequently Asked Questions -
  Statement of Investigator (Form FDA 1572) (PDF -
 672 KB)
Integrated Summaries of Effectiveness and Safety:     Final    4/20/2009
 Location Within the Common Technical Document (PDF -
  98 KB)
Integrated Summary of Effectiveness (PDF - 95 KB)     Draft    7/26/2008
Investigator Responsibilities--Protecting the         Final    10/23/
 Rights, Safety, and Welfare of Study Subjects (PDF -           2009
  163 KB)
Levothyroxine Sodium Products Enforcement of August   Final    7/2001
 14, 2001 Compliance Date and Submission of New
 Applications (PDF - 24 KB)
Medication Guides--Adding a Toll-Free Number for      Final    6/8/2009
 Reporting Adverse Events (PDF - 67 KB)
National Uniformity for Nonpresciption Drugs -        Final    4/1998
 Ingredient Listing for OTC Drugs (PDF - 74 KB)
PET Drug Applications - Content and Format for NDAs   Draft    3/7/2000
 and ANDAs (PDF - 153 KB) [(Issued , Posted 3/7/
 2000)
   Sample formats for chemistry,              .......  .........
   manufacturing, and controls sections (PDF - 125
   KB)
   Sample formats for labeling (PDF - 94 KB)  .......  .........
   Sample formats for Form FDA 356h (PDF -    .......  .........
   51 KB)
   Sample formats for user fee Form FDA 3397  .......  .........
   (PDF - 41 KB)
Pharmacogenomic Data Submissions (PDF - 96 KB)        .......  .........
   Examples of Voluntary Submissions or       Final    3/2005
   Submissions Required Under 21 CFR 312, 314, or
   601 (PDF - 63 KB)
Pharmacogenomic Data Submissions--Companion Guidance  Draft    8/28/2007
 (PDF - 211 KB)
Planning for the Effects of High Absenteeism to       Draft    1/7/2010
 Ensure Availability of Medically Necessary Drug
 Products (PDF - 47KB)
Postmarketing Adverse Even Reporting for Medical      Draft    12/15/
 products and Dietary Supplements During an                     2008
 Influenza Pandemic (PDF - 246 KB)
Postmarketing Safety Reporting for Human Drug and     Draft    3/9/2001
 Biological Products Including Vaccines (PDF - 375
 KB)
Potassium Iodide as a Thyroid Blocking Agent in       Final    12/10/
 Radiation Emergencies (PDF - 40 KB)                            2001
   KI in Radiation Emergencies-Questions and  .......  12/23/
   Answers (PDF - 161 KB)                                       2002
Potassium Iodide Tablets - Shelf Life Extension (PDF  Final    3/8/2004
 - 156 KB)
Procedures for Determining Conflict of Interest and   Draft    3/21/2007
 Eligibility for Participation in FDA Advisory
 Committees (PDF - 68 KB)
Process for Handling Referrals to FDA Under 21 CFR    Final    12/22/
 50.54 Additional Safeguards for Children in                    2006
 Clinical Investigations (PDF - 116 KB) [PDF]
Qualifying for Pediatric Exclusivity Under Section    Final    9/1999
 505A of the Federal Food, Drug, and Cosmetic Act
 (PDF - 57 KB)
Refusal to File (PDF - 304KB)                         Final    7/12/1993
Repeal of Section 507 of the Federal Food, Drug and   Final    Revised
 Cosmetic Act (PDF - 85 KB)                                    5/1998
Reports on the Status of Postmarketing Study          Final    2/15/2006
 Commitments--Implementation of Section 130 of the
 Food and Drug Administration Modernization Act of
 1997 (PDF - 456 KB)
Special Protocol Assessment (PDF - 36 KB)             Final    5/2002
Standards for Prompt Review of Efficacy Supplements   Final    5/15/1998
 (PDF - 76 KB)
Standards for Securing the Drug Supply Chain -        Final    3/26/2010
 Standardized Numerical Identification for
 Prescription Drug Packages
Submission of Patent Information for Certain Old      Draft    11/28/
 Antibiotics (PDF - 42 KB)                                      2008
Submitting and Reviewing Complete Responses to        Final    10/2000
 Clinical Holds (Revised)(PDF - 26 KB)
Submitting Debarment Certification Statements (PDF -  Draft    10/2/98
 144 KB)
Submitting Marketing Applications According to the    Draft    9/5/2001
 ICH/CTD Format: General Considerations (PDF - 50
 KB)
Target Product Profile--A Strategic Development       Draft    3/29/2007
 Process Tool (PDF - 454 KB)
Technical Considerations for Pen, Jet, and Related    Draft    6/2/2009
 Injectors Intended for Use With Drugs and
 Biological Products (PDF - 112 KB)
The Use of Clinical Holds Following Clinical          Draft    4/2002
 Investigator Misconduct (PDF - 33 KB)
Tropical Disease Priority Review Vouchers (PDF - 112  Draft    10/21/
 KB)                                                            2008

[[Page 48204]]

Useful Written Consumer Medication Information        Final    7/17/2006
 (CMI)(PDF - 73 KB)
Using a Centralized IRB Review Process in             Final    3/15/2006
 Multicenter Clinical Trials (PDF - 87 KB)
Waiver of IRB Requirements for Drug and Biological    Final    1/2006
 Product Studies (PDF - 35 KB)
Women and Minorities Guidance Requirements (PDF - 30  Final    7/20/1998
 KB)
Small Entity Compliance Guides
Sterility Requirement for Aqueous-Based Drug          Final    11/7/2001
 Products for Oral Inhalation--Small Entity
 Compliance Guide (PDF - 18 KB)
Labeling OTC Human Drug Products (Small Entity        Draft    12/2004
 Compliance Guide)(PDF - 481 KB)
User Fees
Attachment G--Draft Interim Guidance Document for     Draft    7/16/1993
 Waivers of and Reductions in User Fees (PDF - 897
 KB)
Classifying Resubmissions in Response to Action       Final    5/14/1998
 Letters (PDF - 76 KB)
Fees-Exceed-the-Costs Waivers Under the Prescription  Final    6/1999
 Drug User Fee Act (PDF - 48 KB)
Guidance for Industry and FDA Staff: Application      Final    4/2005
 User Fees for Combination Products (PDF - 83 KB)
Information Request and Discipline Review Letters     Final    11/2001
 Under the Prescription Drug User Fee Act (PDF - 27
 KB)
Submitting Separate Marketing Applications and        Final    12/30/
 Clinical Data for Purposes of Assessing User Fees              2004
 (PDF - 211 KB)
User Fee Waivers for FDC and Co-Packaged HIV Drugs    Final    2/7/2007
 for PEPFAR (PDF - 46 KB) (Issued , Posted 2/7/2007)
------------------------------------------------------------------------

IV. Center for Devices and Radiological Health (CDRH)

    For information a specific guidance document or to obtain a paper 
copy, contact:
    Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver 
Spring, MD 20993, 1-800-638-2041, FAX: 301-847-2149, e-mail: 
dsmica@fda.hhs.gov, http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/Default.htm.
    CDRH has no withdrawn guidance documents at this time.
    The following list of current CDRH guidance documents was obtained 
from FDA's Web site on April 22, 2010:

----------------------------------------------------------------------------------------------------------------
                                                                                        Doc           Date
----------------------------------------------------------------------------------------------------------------
Cross-Center Guidance Document List
Guidance for Industry and FDA Staff - User Fees and Refunds    CBER CDRH                       1511     08/27/09
 for Premarket Notification Submissions (510(k)s)
Guidance for Industry, FDA Staff, and Third Parties -          CBER CDRH                       1200     08/06/09
 Inspection by Accredited Persons Under The Medical Device
 User Fee and Modernization Act of 2002 and the FDA
 Amendments Act of 2007; Accreditation Criteria
Presenting Risk Information in Prescription Drug and Medical   .......................  ...........  ...........
 Device Promotion
User Fees and Refunds for Premarket Approval Applications      CBER CDRH                       1681     03/13/09
Guidance for Industry, FDA Staff, and FDA-Accredited Third     CBER CDRH                       1532     03/02/09
 Parties - Manufacturer's Notification of the Intent to Use
 an Accredited Person under the Accredited Persons Inspection
 Program Authorized by Section 228 of the Food and Drug
 Administration Amendments Act of 2007 (FDAAA)
Assay Migration Studies for In Vitro Diagnostic Devices        CBER CDRH/OIVD                  1660     01/05/09
Submission and Review of Sterility Information in Premarket    CBER CDRH/ODE                   1615     12/12/08
 Notification (510(k)) Submissions for Devices Labeled as
 Sterile
Modifications to Devices Subject to Premarket Approval (PMA) - CBER CDRH                       1584     12/11/08
  The PMA Supplement Decision
Draft Guidance for HDE Holders, Institutional Review Boards    CBER CDRH                       1668     08/05/08
 (IRBs), Clinical Investigators, and FDA Staff - Humanitarian
 Device Exemption (HDE) Regulation: Questions and Answers
FY 2009 Medical Device User Fee Small Business Qualification   CBER CDRH                ...........     08/01/08
 and Certification (PDF only)
FDA and Industry Actions on Premarket Approval Applications    CBER CDRH                       1218     06/30/08
 (PMAs): Effect on FDA Review Clock and Goals
Guidance for Industry and FDA Staff: Expedited Review of       CBER CDRH                        108     02/29/08
 Premarket Submissions for Devices
Interactive Review for Medical Device Submissions: 510(k)s,    CBER CDRH                       1655     02/28/08
 Original PMAs, PMA Supplements, Original BLAs, and BLA
 Supplements
Guidance for Industry and FDA Staff: Bundling Multiple         CBER CDRH                       1215     06/22/07
 Devices or Multiple Indications in a Single Submission
Guidance on Pharmacogenetic Tests and Genetic Tests for        CBER CDER CDRH                  1549     02/09/06
 Heritable Markers
Annual Reports for Approved Premarket Approval Applications    CBER CDRH                       1585     10/26/06
 (PMA)
Real-Time Premarket Approval Application (PMA) Supplements     CBER CDRH                        673     04/28/06
Informed Consent for In Vitro Diagnostic Device Studies Using  CBER CDRH                       1588     04/25/06
 Leftover Human Specimens that are Not Individually
 Identifiable
Guidance for the Content of Premarket Submissions for          CBER CDRH/ODE CDRH/OIVD          337     05/11/05
 Software Contained in Medical Devices
Use of Symbols on Labels and in Labeling of In Vitro           CBER CDRH                       4444     11/30/04
 Diagnostic Devices Intended for Professional Use
Resolution of Disputes Concerning Payment or Refund of         CBER CDRH                       1303     11/17/04
 Medical Device User Fees Under MDUFMA

[[Page 48205]]

Guidance for Industry and FDA Staff - User Fees and Refunds    CBER CDRH                       1511     08/27/09
 for Premarket Notification Submissions (510(k)s)
FDA and Industry Actions on Premarket Notification (510(k))    CBER CDRH                       1219     05/21/04
 Submissions: Effect on FDA Review Clock and Performance
 Assessment
Premarket Assessment of Pediatric Medical Devices              CBER CDRH                       1220     05/14/04
Guidance for Industry and FDA: User Fees and Refunds for       CBER CDRH                       1224     11/24/03
 Premarket Approval Applications
Premarket Approval Application Modular Review                  CBER CDRH/ODE                    835     11/03/03
Premarket Approval Application Filing Review                   CBER CDRH/ODE CDRH/OIVD          297     05/01/03
Assessing User Fees: PMA Supplement Definitions, Modular PMA   CBER CDRH                       1201     02/25/03
 Fees, BLA and Efficacy Supplement Definitions, Bundling
 Multiple Devices in a Single Application, and Fees for
 Combination Products
The Least Burdensome Provisions of the FDA Modernization Act   CBER CDRH/ODE                   1332     10/04/02
 of 1997: Concept and Principles; Final Guidance for FDA and
 Industry
General Principles of Software Validation; Final Guidance for  CBER CDRH/OC                     938     01/11/02
 Industry and FDA Staff
OC Guidance Documents
Guidance for Industry and FDA Staff - Implementation of        OC/DRMO/RPSB                    1657     10/08/09
 Medical Device Establishment Registration and Device Listing
 Requirements Established by the Food and Drug Administration
 Amendments Act of 2007
Class II Special Controls Guidance Document: Labeling for      OC/DE2/OBGUB                    1688     12/23/08
 Natural Rubber Latex Condoms Classified Under 21 CFR
 884.5300
Medical Device Tracking; Guidance for Industry and FDA Staff   OC                               169     01/25/10
Surveillance and Detention Without Physical Examination of     OC/DE2                          1141     07/11/08
 Surgeons' and/or Patient Examination Gloves
Surveillance and Detention Without Physical Examination of     OC/DE2                          1139     07/11/08
 Condoms
The Review and Inspection of Premarket Approval Application    OIVD OC                         1566     01/08/08
 Manufacturing Information and Operations
The Review and Inspection of Premarket Approval Applications   OC/DBM                          1602     01/08/08
 under the Bioresearch Monitoring Program
Class II Special Controls Guidance Document: Oxygen Pressure   OC                              1227     02/27/07
 Regulators and Oxygen Conserving Devices
Decorative, Non-corrective Contact Lenses                      OC/DE1                          1613     11/24/06
Inspection of Medical Device Manufacturers                     OC/DPO/FPB               ...........     06/15/06
Compliance with Section 301 of the Medical Device User Fee     OC                              1217     05/01/06
 and Modernization Act of 2002, as amended - Prominent and
 Conspicuous Mark of Manufacturers on Single-Use Devices
Class II Special Controls Guidance Document: Labeling for      OC/DE2/OBGUB                    1548     11/14/05
 Male Condoms Made of Natural Rubber Latex
Draft Guidance for Industry and FDA Staff - Functional         ODE OC                          1304     10/06/05
 Indications for Implantable Cardioverter Defibrillators
Guidance for Industry - Cybersecurity for Networked Medical    ODE OC                          1553     01/14/05
 Devices Containing Off-the-Shelf (OTS) Software
Consumer-Directed Broadcast Advertising of Restricted Devices  OC                              1513     02/10/04
User Labeling for Devices that Contain Natural Rubber (21 CFR  OC                              1212     04/01/03
 801.437); Small Entity Compliance Guide
Quality System Information for Certain Premarket Application   OC/DE3                          1140     02/03/03
 Reviews; Guidance for Industry and FDA Staff
General Principles of Software Validation; Final Guidance for  CBER CDRH/OC                     938     01/11/02
 Industry and FDA Staff
Sterilized Convenience Kits for Clinical and Surgical Use      OC                              1390     01/07/02
Labeling Recommendations for Single-Use Devices Reprocessed     OC/DE3                         1392     07/30/01
 by Third Parties and Hospitals; Final Guidance for Industry
 and FDA
Implementation of the Biomaterials Access Assurance Act of      OC                             1324     04/02/01
 1998
Labeling for Electronic Anti-Theft Systems                     OC/DE3                          1170     08/15/00
Enforcement Priorities for Single-Use Devices Reprocessed by   OC/DE3                          1168     08/14/00
 Third Parties and Hospitals
Alternative to Certain Prescription Device Labeling            OC                              1150     01/21/00
 Requirements
Regulating In Vitro Diagnostic Device (IVD) Studies            OC/DBM                          1132     12/17/99
Guidance on Electrosurgical Devices and the Application of     OC/DE1                          1129     11/15/99
 the Performance Standard for Electrode Lead Wires and
 Patient Cables (PDF version)
Guidance for FDA Staff: Civil Money Penalty Policy             OC                              1124     06/08/99
Preparing Notices of Availability of Investigational Medical   OC/DBM                          2229     03/19/99
 Devices and for Recruiting Study Subjects
Performance Standard for Electrode Lead Wires and Patient      OC                              1197     03/16/98
 Cables
Information about Lasers: An Important Letter to               OC/DE2                          8323     06/27/97
 Ophthalmologists About Lasers for Refractive Surgery
Design Control Guidance For Medical Device Manufacturers       OC/DE3                           994     03/11/97
Prospective Manufacturers of Barrier Devices Used During Oral  OC/DE2                          1394     10/31/96
 Sex for STD Protection
Electromagnetic Compatibility - A Letter to Industry           OC/DE3                          1087     09/18/96
Shielded Trocars and Needles used for Abdominal Access during  OC/DE2                          1122     08/23/96
 Laparoscopy (PDF Version)
Letter to Manufacturers and Initial Distributors of            OC/DE2                          2507     05/23/96
 Hemodialyzers (PDF only)
Reuse of Medical Disposable Devices Policy                     OC/DE3                           961     12/27/95
Letter to Medical Device Manufacturer on Pentium processors    OC                               456     02/14/95
 (PDF only)

[[Page 48206]]

Medical Devices and EMI: The FDA Perspective                   OC/DE3                          1082     01/01/95
Pesticide Regulation Notice 94-4 Interim Measures for the      OC/DE2                           851     06/30/94
 Registration of Antimicrobial Products/Liquid Chemical
 Germicides with Medical Device Use Claims (PDF only)
All Device Manufacturers/Repackers Using Cotton (PDF Version)  OC/DE2                           101     04/22/94
Letter - Condom Manufacturers and Distributors (PDF only)      OC/DE2                            56     04/05/94
Letter - Manufacturers, Distributors and Importers of Condom   OC/DE2                            52     02/23/94
 Products (included in Condom Packet 398) (PDF only)
Manufacturers And Initial Distributors Of Sharps Containers    OC/DE2                           933     02/03/94
 And Destroyers Used By Health Care Professionals (PDF
 Version)
Endoscopy and Laparoscopy Accessories (PDF only)               OC/DE1                           545     05/17/93
Letter to Industry, Powered Wheelchair Manufacturers from      OC/DE2                           869     05/10/93
 RMJohnson (PDF Only)
Latex Labeling Letter (Johnson) (PDF only)                     OC/DE2                           831     03/18/98
Dental Handpiece Sterilization (Dear Doctor Letter) (PDF       OC/DE2                           589     09/28/92
 only)
Computerized Devices/Processes Guidance (PDF Version)          OC/DE3                           247     05/01/92
Commercial Distribution/Exhibit Letter (PDF only)              OC                               246     04/10/92
Quality Assurance Guidelines for Hemodialysis Devices          OC/DE3                           507     02/01/91
Letter - Manufacturers, Importers, and Repackagers of Condoms  OC/DE2                            53     02/13/89
 for Contraception or Sexually-Transmitted Disease Prevention
 (Holt) (PDF only)
Color Additive Status List (PDF Only)                          OC                               268     02/01/89
Color Additive Petitions (PDF Only)                            OC                               296     06/01/87
Condoms: Inspection and Sampling at Domestic Manufacturers     OC/DE2                           293     04/08/87
 and of all Repackers; Sampling from all Importers (Damaska
 Memo to Field on 4/8/87) (PDF only)
All U.S. Condom Manufacturers, Importers and Repackagers (PDF  OC/DE2                          2510     04/07/87
 only)
Standard Specification for Rubber Contraceptives (Condoms)     OC/DE2                           628     10/28/83
 (PDF Only)
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol;    OC/DE2                          1019     06/23/78
 Proposed Maximum Residue Limits and Maximum Levels of
 Exposure (PDF only)
Medical Device Electromagnetic Interference Issues, Problem    OC/DE3                          1086  ...........
 Reports, Standards, and Recommendations (PDF Version)
Office of the Center Director Guidance Documents
Resolving Scientific Disputes Concerning The Regulation Of     OCD                             1121    07/02/01
 Medical Devices, A Guide To Use Of The Medical Devices
 Dispute Resolution Panel; Final Guidance for Industry and
 FDA
OCER Guidance Documents
Guidance for Industry and FDA Staff: Acceptable Media for      OCER/DMQRP/EPB           ...........     03/18/10
 Electronic Product User Manuals
Draft Guidance for Industry, MQSA Inspectors and FDA Staff -   OCER/DMQRP                      1695     10/09/09
 The Mammography Quality Standards Act Final Regulations:
 Modifications and Additions to Policy Guidance Help System
 13
Radiation Safety Considerations for X-Ray Equipment Designed   OCER/DMQRP                      1680     12/24/08
 for Hand-Held Use
Inspection of Domestic and Foreign Manufacturers of            OCER/DMQRP/RPB           ...........     05/15/08
 Diagnostic X Ray Equipment
Medical Glove Guidance Manual                                  OCER/DSMICA                     1661     01/22/08
Inspection and Field Testing of Radiation-Emitting Electronic  OCER/DMQRP               ...........     10/31/07
 Products
Impact-Resistant Lenses: Questions and Answers                 OCER/DSMICA                       23     10/26/07
Procedures for Renewal and Amendment of Certain Laser Light    OCER/DMQRP                      1639     09/25/07
 Show Variances (Laser Notice 55)
Compliance Guide for Cabinet X-Ray Systems                     OCER/DMQRP                      1634     09/19/07
Writing Dear Doctor Letters for Recalls of Implantable         OCER/DHC                        1645     07/19/07
 Cardioverter Defibrillators (ICDs)
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2- OCER/DMQRP                      1346     06/24/07
 22; (Laser Notice No. 50)
Performance Standard for Diagnostic X-Ray Systems and Their    OCER/DMQRP                      1640     06/07/07
 Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33);
 Small Entity Compliance Guide
Application for a Variance From 21 CFR 1040.11(c) for a Laser  .......................  ...........     05/01/07
 Light Show, Display, or Device
Approval of Alternate Means of Labeling for Laser Products     OCER/DMQRP                      1633     03/23/07
 (Laser Notice 53)
The Mammography Quality Standards Act Final Regulations:       OCER/DMQRP                      1623     02/02/07
 Modifications and Additions to Policy Guidance Help System
 12
Exemption from Certain Reporting and Recordkeeping             OCER/DMQRP                      1612     10/20/06
 Requirements for Television Receivers and Computer Monitors
 with Cathode Ray Tubes
Exemption from Certain Reporting and Recordkeeping             OCER/DMQRP                      1611     10/20/06
 Requirements for Microwave Ovens
Provision for Alternate Measure of the Computed Tomography     OCER/DMQRP                      1609     10/20/06
 Dose Index (CTDI) to Assure Compliance with the Dose
 Information Requirements of the Federal Performance Standard
 for Computed Tomography
Hospital Bed System Dimensional and Assessment Guidance to     OSB/DPS OCER/DHC                1537     03/10/06
 Reduce Entrapment
Compliance Program Guidance Manual CP 7386.003 Field           OCER/DMQRP                      1600     02/08/06
 Compliance Testing of Diagnostic (Medical) X-ray Equipment -
 Guidance for FDA Staff
Exemption from Reporting and Recordkeeping Requirements for    OCER/DMQRP OCER/DMQRP/          1592     01/06/06
 Low Power Laser Products (Laser Notice 54)                     EPDB
Applicability of the Performance Standard for High-Intensity   OCER/DMQRP/EPDB                 1565     11/06/05
 Mercury Vapor Discharge Lamps (21 CFR 1040.30)
Mammography Facility Surveys, Mammography Equipment            OCER/DMQRP/ICB                  6409     09/13/05
 Evaluations, and Medical Physicist Qualification
 Requirements under MQSA
Information Disclosure by Manufacturers to Assemblers for      OCER/DMQRP/DDB                  2619     09/05/03
 Diagnostic X-ray Systems

[[Page 48207]]

Frequently-Asked-Questions about the Reprocessing and Reuse    OCER/DHC                        1427     07/16/03
 of Single-Use Devices by Third-Party and Hospital
 Reprocessors; Three Additional Questions
Guidance on the Department of Defense Exemption from the FDA   OCER/DMQRP                      1412     07/12/02
 Performance Standard for Laser Products (Laser Notice No.
 52)
Frequently-Asked-Questions about the Reprocessing and Reuse    OCER/DHC                        1408     07/09/02
 of Single-Use Devices by Third-Party and Hospital
 Reprocessors: Three Additional Questions; Final Guidance for
 Industry and FDA Staff
Compliance Guidance: The Mammography Quality Standards Act     OCER/DMQRP/ICB                  6400     11/05/01
 Final Regulations: Preparing For MQSA Inspections; Final
Frequently-Asked-Questions about the Reprocessing and Reuse    OCER/DHC                        1333     07/06/01
 of Single-Use Devices by Third-Party and Hospital
 Reprocessors; Final Guidance for Industry and FDA Staff
Responsibilities of Laser Light Show Projector Manufacturers,  OCER/DMQRP/EPDB                 1349     05/27/01
 Dealers, and Distributors; (Laser Notice 51)
Guidance on Medical Device Patient Labeling                    OCER/DHC                        1128     04/19/01
CDRH Manual for the Good Guidance Practices (GGP)              OCER/DHC                        1323     02/09/01
 Regulations; Final Guidance for FDA Staff
Implementation of Third Party Programs Under the FDA           OCER/DSMICA                     1160     02/02/01
 Modernization Act of 1997; Final Guidance for Staff,
 Industry and Third Parties
Guidance for Industry - Wireless Medical Telemetry Risks and   .......................         1173     09/27/00
 Recommendations
Medical Device Use-Safety: Incorporating Human Factors         OCER/DHC                        1497     07/18/00
 Engineering into Risk Management
Regulation of Medical Devices: Background Information for      OCER/DSMICA                      610     04/14/99
 International Officials
Accidental Radioactive Contamination of Human Food and Animal  OCER/DMQRP                      1071     08/13/98
 Feeds: Recommendations for State and Local Agencies (PDF
 Only)
Overview of FDA Modernization Act of 1997, Medical Device      OCER/DSMICA                     1174     02/19/98
 Provisions
Medical Device Appeals and Complaints: A Guidance on Dispute   OCER/DSMICA                      396     02/19/98
 Resolution (PDF Only)
FDA Modernization Act of 1997 - Guidance for the Device        OCER                             434     02/06/98
 Industry on Implementation of Highest Priority Provisions
Medical Device Reporting for Manufacturers                     OCER/DSMICA                      987     03/01/97
Human Factors Points to Consider for IDE Devices               OCER/DHC                         839     01/17/97
In Vitro Diagnostic Devices: Guidance for the Preparation of   OCER/DSMICA                      471     01/01/97
 510(k) Submissions
Do It By Design - An Introduction to Human Factors in Medical  OCER/DHC                         995     12/01/96
 Devices
Medical Device Quality Systems Manual                          OCER/DSMICA                     6303     12/01/96
Emitted Laser Beam as Emission Indicator for Class II and      OCER/DMQRP               ...........     09/05/96
 Class IIIa Laser Products (Laser Notice 49) (PDF only)
Identification Labels for Certain Class I Laser Products       OCER/DMQRP               ...........     09/05/96
 (Laser Notice 48) (PDF Only)
Effective Visual Control of Laser Projections (Laser Notice    OCER/DMQRP               ...........     06/06/96
 47) (PDF Only)
Medical Device Reporting for User Facilities (PDF Only)        OCER/DHC                 ...........     04/01/96
A Guide for the Submission of An Abbreviated Radiation Safety  OCER/DMQRP/DDB                   977     03/01/96
 Reports on Cephalometric Devices Intended for Diagnostic Use
A Guide For The Submission Of An Abbreviated Initial Report    OCER/DMQRP/DDB                   978  ...........
 On X-Ray Tables, Cradles, Film Changers Or Cassette Holders
 Intended For Diagnostic Use (PDF Only)
All Holders of Approved Variances For Laser Light Shows and    OCER/DMQRP               ...........     12/11/95
 Displays (Laser Notice 46) (PDF Only)
Guide for Preparing Product Reports for Lasers and Products    OCER/DMQRP/EPDB                  277     09/01/95
 Containing Lasers (PDF Only)
Labeling of Laser Products (Laser Notice 45) (PDF Only)        OCER/DMQRP               ...........     08/15/95
User Instruction for Medical Products (Laser Notice 44) (PDF   OCER/DMQRP               ...........     08/11/95
 Only)
Abbreviated Reports on Radiation Safety for Microwave          OCER/DMQRP/EPDB                  236     08/01/95
 Products (Other Than Microwave Ovens)- E.G. Microwave
 Heating, Microwave Diathermy, RF Sealers, Induction,
 Dielectric Heaters, Security Systems (PDF Only)
Certification Statement for the Impact Resistance Test (PDF    OCER/DSMICA                     1460     10/25/93
 Only)
Manufacturers/Assemblers of Diagnostic X-ray Systems:          OCER/DMQRP/DDB                   116     10/13/93
 Enforcement Policy for Positive-Beam Limitation (PBL)
 Requirements in 21 CFR 1020.31(g) (PDF Only)
Human Factors Principles for Medical Device Labeling (PDF      OCER/DHC                         227     09/01/93
 Only)
Beam Attenuators and Emission Indicators for Class II and      OCER/DMQRP               ...........     06/07/93
 IIIa Laser Systems (Laser Notice 43) (PDF Only)
Compliance Guide for Laser Products (FDA 86-8260) (PDF Only)   OCER/DMQRP/EPDB                  278     06/01/92
Clarification of Compliance Requirements for Certain           OCER/DMQRP               ...........     12/18/89
 Manufacturers Who Incorporate Certified Class I Laser
 Products into Their Products (Laser Notice 42) (PDF Only)
Labeling - Regulatory Requirements for Medical Devices (FDA    OCER/DSMICA                      470     09/01/89
 89-4203) (PDF Only)
Clarification of Radiation Control Regulations for Diagnostic  OCER/DMQRP                       758     03/01/89
 X-Ray Equipment (FDA 89-8221)
Imports Radiation-Producing Electronic Products (FDA 89-8008)  OCER/DMQRP/EPDB                  756     11/01/88
 (PDF Only)
Low Power Laser Reporting Exemption (Laser Notice 40) (PDF     OCER/DMQRP               ...........     08/09/88
 Only)
Guide for Establishing and Maintaining a Calibration           OCER/DMQRP/EPDB                  286     03/01/88
 Constancy Intercomparison System for Microwave Oven
 Compliance Survey Instruments (FDA 88-8264)] (PDF Only)
Impact Resistant Lenses: Questions and Answers (FDA 87-4002)   OCER/DSMICA                       23     09/01/87
 (PDF Only)
User Instructions - Multi Axis Workstations (Laser Notice 39)  OCER/DMQRP               ...........     06/24/87
 (PDF Only)
Importation for Investigation And Evaluation (Laser Notice     OCER/DMQRP               ...........     05/22/87
 38) (PDF Only)
Policy on Lamp Compatibility (sunlamps) (PDF Only)             OCER/DMQRP/EPDB                 2343     09/02/86
Procedures for Laboratory Compliance Testing of Television     OCER/DMQRP/EPDB                  945     05/01/86
 Receivers (PDF Only)

[[Page 48208]]

Guide for the Submission of Initial Reports on Computed        OCER/DMQRP/DDB                   271     12/01/85
 Tomography X-Ray Systems
Walk-In Workstations (Laser Notice 37) (PDF Only)              OCER/DMQRP               ...........     10/21/85
Low Power Laser Exemption (Laser Notice 36) (PDF Only)         OCER/DMQRP               ...........     08/23/85
Policy on Warning Label Required on Sunlamp Products (PDF      OCER/DMQRP/EPDB                 1343     06/25/85
 Only)
User Instruction Hazard Warnings (Laser Notice 35) (PDF Only)  OCER/DMQRP               ...........     02/05/85
Medical Laser Delivery System Interlocks (Laser Notice 34)     OCER/DMQRP               ...........     01/20/85
 (PDF Only)
A Guide for the Submission of Initial Reports on Diagnostic X- OCER/DMQRP/DDB                   257     01/01/82
 Ray Systems and their Major Components
Exemption from Reporting and Record keeping Requirements for   OCER/DMQRP/EPDB                  343     09/16/81
 Certain Sunlamp Product Manufacturers (PDF Only)
Letter to All Manufacturers and Importers of Microwave Ovens:  OCER/DMQRP/EPDB                  880     08/24/81
 Retention of Records Required by 21 CFR 1002 (PDF Only)
Investigational Medical Laser Significant Risk Device (Laser   OCER/DMQRP               ...........     05/18/81
 Notice 31) (PDF Only)
Laser Diodes Used in Fiber Optics Communication Systems        OCER/DMQRP               ...........     10/16/80
 (Laser Notice 27) (PDF Only)
Alternate Wording For Caution Statement (Laser Notice 30)      OCER/DMQRP               ...........     08/25/80
 (PDF Only)
Guide for the filing of Annual Reports for X-Ray Components    OCER/DMQRP/EPDB                  253     07/01/80
 and Systems (PDF Only)
Open Door Operation of Microwave Ovens as a Result of Oven     OCER/DMQRP/EPDB                  646     03/28/80
 Miswiring (PDF Only)
Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept.   OCER/DMQRP               ...........     09/14/79
 of Commerce (Laser Notice 25) (PDF Only)
Laser Light Shows Subject to Laser Product Performance         OCER/DMQRP               ...........     11/23/77
 Standard (Laser Notice 22) (PDF Only)
Emission Delay - Remote Interlock Connector (Laser Notice 21)  OCER/DMQRP               ...........     11/11/77
 (PDF Only)
Optional Interlocks - Labeling (Laser Notice 17) (PDF Only)    OCER/DMQRP               ...........     03/02/77
Warning Labels For Dye And Multiple Wavelength Lasers (Laser   OCER/DMQRP               ...........     03/02/77
 Notice 16) (PDF Only)
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11       OCER/DMQRP               ...........     12/08/76
 (Laser Notice 15) (PDF Only)
Lasers Manufactured and Used In-House (Laser Notice 14) (PDF   OCER/DMQRP               ...........     11/23/76
 Only)
Manufacture and Certification of Laser Kits (Laser Notice 13)  OCER/DMQRP               ...........     10/14/76
 (PDF Only)
Remote Interlock Connectors (Laser Notice 11) (PDF Only)       OCER/DMQRP               ...........     10/07/76
Interlock Design (Laser Notice 12) (PDF Only)                  OCER/DMQRP               ...........     09/09/76
Emission Indicator - Visibility (Laser Notice 10) (PDF Only)   OCER/DMQRP               ...........     08/31/76
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11       OCER/DMQRP               ...........     08/23/76
 (Laser Notice 9) (PDF Only)
Viewing Optics - Sighting Telescope (Laser Notice 8) (PDF      OCER/DMQRP               ...........     08/05/76
 Only)
Components and Repair (Laser Notice 7) (PDF Only)              OCER/DMQRP               ...........     06/23/76
Emission Indicators - Brightness (Laser Notice 6) (PDF Only)   OCER/DMQRP               ...........     06/22/76
Protective Eyewear - Visibility of Emission Indicator (Laser   OCER/DMQRP               ...........     11/21/75
 Notice 4) (PDF Only)
Emission Indicators on Energy Source (Laser Notice 3) (PDF     OCER/DMQRP               ...........     11/21/75
 Only)
Laser Energy Source (Laser Notice 2) (PDF Only)                OCER/DMQRP               ...........     11/21/75
COMPARISON CHART: 1996 QUALITY System Regulation Versus 1978   OCER/DSMICA              ...........  ...........
 GOOD Manufacturing Practices Regulation Versus ANSIIISOIASQC
 Q9001-1994 AND ISO/DIS 13485:1996 (PDF Version)
ODE Guidance Documents 2010
Draft Guidance for Industry and FDA Staff: Heart Valves -      ODE/DCD/CSPDB                   1607     01/20/10
 Investigational Device Exemption (IDE) and Premarket
 Approval (PMA) Applications
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1574     04/05/10
 Controls Guidance Document: Transcutaneous Electrical Nerve
 Stimulator with Limited Output for Pain Relief
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1670     04/05/10
 Controls Guidance Document: Transcutaneous Electrical Nerve
 Stimulator for Pain Relief Intended
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1580     04/05/10
 Controls Guidance Document: Powered Muscle Stimulator with
 Limited Output for Muscle Conditioning
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1577     04/05/10
 Controls Guidance Document: Powered Muscle Stimulator for
 Rehabilitation
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1578     04/05/10
 Controls Guidance Document: Powered Muscle Stimulator with
 Limited Output for Rehabilitation
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1575     04/05/10
 Controls Guidance Document: Transcutaneous Electrical
 Stimulator for Aesthetic Purposes
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1576     04/05/10
 Controls Guidance Document: Transcutaneous Electrical
 Stimulator with Limited Output for Aesthetic Purposes
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1579     04/05/10
 Controls Guidance Document: Powered Muscle Stimulator for
 Muscle Conditioning
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1572     04/05/10
 Controls Guidance Document: Cutaneous Electrode
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1571     04/05/10
 Controls Guidance Document: Electroconductive Media
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DRARD/ULDB                  1573     04/05/10
 Controls Guidance Document: Transcutaneous Electrical Nerve
 Stimulator for Pain Relief
Guidance for Industry and FDA Staff - Total Product Life       ODE/DAGID/GHDB                  1694  ...........
 Cycle: Infusion Pump - Premarket Notification [510(k)]
 Submissions
ODE Guidance Documents 2008 - 2009
Guidance for Industry and FDA Staff - Class II Special         ODE/DGRND/PRSDB                 1684     10/16/09
 Controls Guidance Document: Wound Dressing with Poly(diallyl
 dimethyl ammonium chloride) (pDADMAC) Additive

[[Page 48209]]

Draft Guidance for Industry and FDA Staff - Clinical Study     ODE/DCD/CEMB                    1708     09/14/09
 Designs for Surgical Ablation Devices for Treatment of
 Atrial Fibrillation
Class II Special Controls Guidance Document: Dental Amalgam,   ODE/DAGID/DEDB                  1192     07/28/09
 Mercury, and Amalgam Alloy - Guidance for Industry and FDA
 Staff
Draft Guidance for Industry and FDA Staff: Investigational     ODE/DOED/VEDB                   1651     04/17/09
 Device Exemption (IDE) Guidance for Retinal Prostheses
Guidance for Industry and FDA Staff: Regulatory Requirements   ODE/DOED/ENTB                   1696     02/25/09
 for Hearing Aid Devices and Personal Sound Amplification
 Products
Guidance for Industry: Designation of Special Controls for     ODE/DRARD/OGDB                  1693     01/05/09
 Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300);
 Small Entity Compliance Guide
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DGRND/PRSB                  1628     12/22/08
 Controls Guidance Document: Tissue Expander
Submission and Review of Sterility Information in Premarket    CBER CDRH/ODE                   1615     12/12/08
 Notification (510(k)) Submissions for Devices Labeled as
 Sterile
Draft Guidance for Industry and FDA Staff - Clinical           ODE/DRARD/ULDB                  1636     09/19/08
 Investigations of Devices Indicated for the Treatment of
 Urinary Incontinence
Guidance for Industry and FDA Staff - Information for          OSEL ODE/DRARD                   560     09/09/08
 Manufacturers Seeking Marketing Clearance of Diagnostic
 Ultrasound Systems and Transducers
Guidance for Industry and FDA Staff: Clinical Study Designs    ODE/DCD/CEMB                    1678     08/05/08
 for Catheter Ablation Devices for Treatment of Atrial
 Flutter
Guidance for Industry and FDA Staff - Class II Special         OSEL ODE/DRARD                  1547     07/17/08
 Controls Guidance Document: Bone Sonometers
Guidance for Industry and FDA Staff - Intravascular            ODE/DAGID/GHDB                  1189     07/11/08
 Administration Sets Premarket Notification Submissions
 [510(k)]
Guidance for Industry and FDA Staff: Class II Special          ODE/DGRND/PRSB                  1630     05/30/08
 Controls Guidance Document: Tissue Adhesive for the Topical
 Approximation of Skin
Draft Guidance for Industry and FDA Staff - Class II Special   ODE/DCD/ICDB                    1608     05/30/08
 Controls Guidance Document for Certain Percutaneous
 Transluminal Coronary Angioplasty (PTCA) Catheters
Guidance for Industry and FDA Staff: Display Accessories for   OSEL ODE/DRARD                  1617     05/30/08
 Full-Field Digital Mammography Systems-Premarket
 Notification (510(k)) Submissions
Draft Guidance for Industry and FDA Staff: Class II Special    OSEL ODE/DRARD                  1616     05/30/08
 Controls Guidance Document: Full Field Digital Mammography
 System
Guidance for Industry and FDA Staff: Hemodialysis Blood        ODE/DRARD/GRDB                  1649     04/23/08
 Tubing Sets - Premarket Notification [510(k)] Submissions
Guidance for Industry and FDA Staff: Investigational Device    ODE/DRARD/GRDB                  1650     04/15/08
 Exemptions (IDEs) for Devices Indicated for Nocturnal Home
 Hemodialysis
Guidance for Industry and FDA Staff: Preparation and Review    ODE/DGRND/ORDB                  1637     04/11/08
 of Investigational Device Exemption Applications (IDEs) for
 Total Artificial Discs
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies  .......................  ...........  ...........
Coronary Drug-Eluting Stents--Nonclinical and Clinical         .......................  ...........  ...........
 Studies -Companion Document
Guidance for Industry and FDA Staff: Coronary and Carotid      ODE/DCD/PVDB ODE/DCD/           1658     02/15/08
 Embolic Protection Devices - Premarket Notification [510(k)]   ICDB
 Submissions
ODE Guidance Documents 2006 - 2007
Guidance for Industry and FDA Staff: Class II Special          ODE/DAGID/GHDB                  1621     10/19/07
 Controls Guidance Document: Remote Medication Management
 System
Guidance for Industry and FDA Staff - Biological Indicator     ODE/DGRND/INCB                  1320     10/04/07
 (BI) Premarket Notification [510(k)] Submissions
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DCD/CEMB                    1597     10/04/07
 Controls Guidance Document: Electrocardiograph Electrodes
Guidance for Industry and FDA Staff - Non-clinical             ODE/DGRND/ORDB                  1647     09/17/07
 Information for Femoral Stem Prostheses
Guidance for Industry and FDA Staff: Class II Special          ODE/DGRND/PRSB                  1629     08/03/07
 Controls Guidance Document: Absorbable Poly(hydroxybutyrate)
 Surgical Suture Produced by Recombinant DNA Technology
Draft Guidance for Industry and FDA Staff - Premarket          ODE                             1557     07/19/07
 Notification [510(k)] Submissions for Medical Devices that
 Include Antimicrobial Agents
Draft Guidance for Industry and FDA Staff - Pulse Oximeters -  ODE/DAGID/ARDB                  1605     07/19/07
 Premarket Notification Submissions [510(k)s]
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/INCB                  1626     07/03/07
 Controls Guidance Document: Filtering Facepiece Respirator
 for Use by the General Public in Public Health Medical
 Emergencies
Guidance for Industry and FDA Staff - Pre-Clinical and         ODE/DGRND/GSDB                  1586     06/18/07
 Clinical Studies for Neurothrombectomy Devices
Guidance for Industry and FDA Staff - Class II Special         ODE/DGRND/ORDB                  1540     06/12/07
 Controls Guidance Document: Intervertebral Body Fusion
 Device
Guidance for Industry and FDA Staff: Dental Handpieces -       ODE/DAGID/DEDB                   556     05/02/07
 Premarket Notification [510(k)] Submissions
Guidance for Industry and FDA Staff - Class II Special         ODE/DRARD/OGDB                  1625     04/24/07
 Controls Guidance Document: Computerized Labor Monitoring
 Systems
Guidance for Industry and FDA Staff - Saline, Silicone Gel,    ODE/DGRND/PRSB                  1239     11/17/06
 and Alternative Breast Implants
Draft Guidance for Industry and FDA Staff - Class II Special   ODE/DGRND                       1558     10/31/06
 Controls Guidance Document: Absorbable Hemostatic Device

[[Page 48210]]

Guidance for Industry and FDA Staff - Medical Device User Fee  ODE                             1216     09/25/06
 and Modernization Act of 2002, Validation Data in Premarket
 Notification Submissions (510(k)s) for Reprocessed Single-
 Use Medical Devices
Guidance for Industry and FDA Staff - Keratome and             ODE/DOED/DSDB                   1604     09/18/06
 Replacement Keratome Blades Premarket Notification [510(k)]
 Submissions
Guidance for Industry and FDA Staff - Humanitarian Device      ODE/ODEOD/POS                   1381     07/18/06
 Exemption (HDE) Regulation: Questions and Answers
Guidance for Industry and FDA Staff - Class II Special         ODE/DOED/ENTB                   1595     06/07/06
 Controls Guidance Document: Olfactory Test Device
Topical Oxygen Chamber for Extremities - Class II Special      ODE/DGRND/PRSB                  1582     04/06/06
 Controls Guidance Document - Draft Guidance for Industry and
 FDA Staff
Guidance for Industry and FDA Staff: Tonometers - Premarket    ODE/DOED/DSDB                   1593     03/27/06
 Notification [510(k)] Submissions
Dental Curing Lights - Premarket Notification [510(k)]         OSEL/DPS ODE/DAGID/DEDB         1591     03/27/06
Class II Special Controls Guidance Document: Implantable       ODE/DCD/PVDB                    1589     02/15/06
 Intra-Aneurysm Pressure Measurement System - Guidance for
 Industry and FDA Staff
ODE Guidance Documents 2004 - 2005
Guidance for Industry and FDA Staff: A Pilot Program to        ODE                             1347     11/10/05
 Evaluate a Proposed Globally Harmonized Alternative for
 Premarket Procedures
Draft Guidance for Industry and FDA Staff: Class II Special    ODE/DOED/ENTB                   1555     11/08/05
 Controls Guidance Document: Tinnitus Masker Devices
Guidance for Industry and FDA Staff - Class II Special         ODE/DGRND/PRSB                  1302     11/07/05
 Controls Guidance Document: Low Energy Ultrasound Wound
 Cleaner
Guidance for Industry and FDA Staff: Dental Composite Resin    ODE/DAGID/DEDB                   642     10/26/05
 Devices - Premarket Notification [510(k)] Submissions
Draft Guidance for Industry and FDA Staff - Functional         ODE OC                          1304     10/06/05
 Indications for Implantable Cardioverter Defibrillators
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/DEDB                  1559     09/20/05
 Controls Document: Oral Rinse to Reduce the Adhesion of
 Dental Plaque
Guidance for Industry and FDA Staff: Format for Traditional    OIVD ODE                        1567     08/12/05
 and Abbreviated 510(k)s
Guidance for Industry and FDA Staff: Medical Devices with      ODE/DAGID/GHDB                   934     08/09/05
 Sharps Injury Prevention Features
Guidance for Industry and FDA Staff - Menstrual Tampons and    ODE/DRARD/OGDB                   166     07/27/05
 Pads: Information for Premarket Notification Submissions
 (510(k)s)
Guidance for the Content of Premarket Submissions for          CBER CDRH/ODE CDRH/OIVD          337     05/11/05
 Software Contained in Medical Devices
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/DEDB                  1512     04/28/05
 Controls Guidance Document: Dental Bone Grafting Material
 Devices
Guidance for Industry - Cybersecurity for Networked Medical    ODE OC                          1553     01/14/05
 Devices Containing Off-the-Shelf (OTS) Software
Guidance for Industry and FDA Staff: Non-Clinical Tests and    ODE/DCD/PVDB ODE/DCD/           1545     01/13/05
 Recommended Labeling for Intravascular Stents and Associated   ICDB
 Delivery Systems
Guidance for Industry and FDA Staff - Class II Special         ODE/DRARD/OGDB ODE/             1234     12/29/04
 Controls Guidance Document: Vascular and Neurovascular         DGRND/PRSB ODE/DCD/
 Embolization Devices                                           PVDB
Guidance for Industry and FDA Staff - Class II Special         ODE/DRARD/OGDB                  1539     12/28/04
 Controls Guidance Document: Assisted Reproduction Laser
 Systems
Guidance for Industry and FDA Staff - Class II Special         ODE/DRARD/ULDB                  1231     12/28/04
 Controls Guidance Document: External Penile Rigidity Devices
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/GHDB                  1541     12/10/04
 Controls Guidance Document: Implantable Radiofrequency
 Transponder System for Patient Identification and Health
 Information
Guidance for Industry and FDA Staff: Clinical Data             ODE/DGRND/ORDB                  1542     12/02/04
 Presentations for Orthopedic Device Applications
Guidance for Industry and FDA Staff - Frequently Asked         ODE                             1544     11/08/04
 Questions (FAQs) on the Status of Reprocessed Single Use
 Devices (SUDs) that receive a Not Substantially Equivalent
 (NSE) Letter
Guidance for Industry and FDA Staff - Clinical Trial           ODE/DGRND/REDB ODE/             1543     10/24/04
 Considerations: Vertebral Augmentation Devices to Treat        DGRND/ORDB
 Spinal Insufficiency Fractures
Guidance for Third Parties and FDA Staff; Third Party Review   OIVD ODE                        2237     09/28/04
 of Premarket Notifications
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/DEDB                  1415     08/23/04
 Controls Guidance Document: Dental Noble Metal Alloys
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/DEDB                  1416     08/23/04
 Controls Guidance Document: Dental Base Metal Alloys
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/DEDB                  1389     05/12/04
 Controls Guidance Document: Root-form Endosseous Dental
 Implants and Endosseous Dental Abutments

[[Page 48211]]

Guidance for Industry and FDA Staff: Spinal System 510(k)s     ODE/DGRND/ORDB                   636     05/03/04
Guidance for Industry and FDA Staff: Premarket Approval        ODE/DAGID/INCB                  1230     04/13/04
 Applications (PMA) for Absorbable Powder for Lubricating a
 Surgeon's Glove
Guidance for Industry and FDA Staff: Surgical Masks -          ODE/DAGID/INCB                    94     03/05/04
 Premarket Notification [510(k)] Submissions; Guidance for
 Industry and FDA
Guidance for Industry and FDA Staff: Vocal Fold Medialization  ODE/DOED/ENTB                   1535     02/13/04
 Devices - Premarket Notification [510(k)] Submissions
Guidance for Industry and FDA Staff: Clinical Study Designs    ODE/DCD/CEMB                    1229     01/09/04
 for Percutaneous Catheter Ablation for Treatment of Atrial
 Fibrillation
ODE Guidance Documents 2002 - 2003
Premarket Notification [510(k)] Submissions for Chemical       ODE/DAGID/INCB                  1420     12/19/03
 Indicators: Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Human Dura        ODE/DGRND/PRSB                    54     12/18/03
 Mater; Guidance for Industry and FDA
Guidance for Industry and FDA Staff - Class II Special         ODE/DAGID/DEDB                  1393     12/02/03
 Controls Guidance Document: Dental Sonography and Jaw
 Tracking Devices
Premarket Approval Application Modular Review                  CBER CDRH/ODE                    835     11/03/03
Guidance for Industry and FDA Staff - Class II Special         ODE/DCD/CEMB                    1363     10/28/03
 Controls Guidance Document: Arrhythmia Detector and Alarm
Guidance for Industry and FDA Staff: Implantable Middle Ear    ODE/DOED/ENTB                   1406     08/01/03
 Hearing Device
Guidance for Industry and FDA Staff: Class II Special          ODE/DRARD/OGDB                  1202     07/28/03
 Controls Guidance Document: Breast Lesion Documentation
 System
Guidance for Industry and FDA Staff: Coronary and Peripheral   ODE/DCD/CEMB                    1228     07/15/03
 Arterial Diagnostic Catheters
Guidance for Industry and FDA Staff: Criteria for Significant  ODE/DRARD                        793     07/14/03
 Risk Investigations of Magnetic Resonance Diagnostic Devices
Pediatric Expertise for Advisory Panels; Guidance for          ODE                             1208     06/03/03
 Industry and FDA Staff
Guidance for Industry and FDA Staff - Class II Special         ODE/DGRND/PRSB                  1387     06/03/03
 Controls Guidance Document: Surgical Sutures
Guidance for Industry and FDA Staff - Class II Special         ODE/DGRND/REDB                   855     06/02/03
 Controls Guidance Document: Resorbable Calcium Salt Bone
 Void Filler Device
Premarket Approval Application Filing Review                   CBER CDRH/ODE CDRH/OIVD          297     05/01/03
Class II Special Controls Guidance Document: Optical           ODE/DAGID                       1203     04/22/03
 Impression Systems for Computer Assisted Design and
 Manufacturing (CAD/CAM) of Dental Restorations; Guidance for
 Industry and FDA
Class II Special Controls Guidance Document: Knee Joint        ODE/DGRND/ORDB                  1418     01/16/03
 Patellofemorotibial and Femorotibial Metal/Polymer Porous-
 Coated Uncemented Prostheses; Guidance for Industry and FDA
Class II Special Controls Guidance Document: Cutaneous Carbon  ODE/DAGID/ARDB                  1335     12/13/02
 Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for
 Industry and FDA
Determination of Intended Use for 510(k) Devices; Guidance     OIVD ODE                         857     12/03/02
 for CDRH Staff (Update to K98-1)
Class II Special Controls Guidance Document: Intraoral         ODE/DAGID/DEDB                  1378     11/12/02
 Devices for Snoring and/or Obstructive Sleep Apnea; Guidance
 for Industry and FDA
Class II Special Controls Guidance Document: Transcutaneous    ODE/DOED/ENTB                   1414     11/07/02
 Air Conduction Hearing Aid System (TACHAS); Guidance for
 Industry and FDA
The Least Burdensome Provisions of the FDA Modernization Act   CBER CDRH/ODE                   1332     10/04/02
 of 1997: Concept and Principles; Final Guidance for FDA and
 Industry
Updated 510(k) Sterility Review Guidance K90-1; Final          ODE                              361     08/30/02
 Guidance for Industry and FDA
Regulatory Status of Disinfectants Used to Process Dialysate   ODE/DAGID/INCB                  1419     08/30/02
 Delivery Systems and Water Purification Systems for
 Hemodialysis; Guidance for Industry and FDA
Class II Special Controls Guidance Document:                   ODE/DGRND/ORDB                   668     07/17/02
 Polymethylmethacrylate (PMMA) Bone Cement; Guidance for
 Industry and FDA
Class II Special Controls Guidance Document: Apnea Monitors;   ODE/DAGID                       1178     07/17/02
 Guidance for Industry and FDA
Cardiac Ablation Catheters Generic Arrhythmia Indications for  ODE/DCD/CEMB                    1382     07/01/02
 Use; Guidance for Industry
Guidance for Resorbable Adhesion Barrier Devices for Use in    ODE/DGRND/PRSB ODE/             1356     06/18/02
 Abdominal and/or Pelvic Surgery; Guidance for Industry         DRARD/OGDB
Class II Special Controls Guidance Document: Hip Joint Metal/  ODE/DGRND/ORDB                  1328     04/30/02
 Polymer Constrained Cemented or Uncemented Prosthesis;
 Guidance for Industry and FDA
Class II Special Controls Guidance Document: Endolymphatic     ODE/DOED/ENTB                    791     04/29/02
 Shunt Tube with Valve; Guidance for Industry and FDA
Premarket Notification [510(k)] Submissions for Medical        ODE/DAGID/INCB                  1388     03/07/02
 Sterilization Packaging Systems in Health Care Facilities;
 Draft Guidance for Industry and FDA
Class II Special Controls Guidance Document: Medical Washers   ODE/DAGID/INCB                  1252     02/07/02
 and Medical Washer-Disinfectors; Guidance for the Medical
 Device Industry and FDA Review Staff
ODE Guidance Documents 2000 - 2001
Class II Special Controls Guidance Document: Ingestible        ODE/DRARD/GRDB                  1385     11/28/01
 Telemetric Gastrointestinal Capsule Imaging System; Final
 Guidance for Industry and FDA

[[Page 48212]]

Class II Special Controls Guidance Document: Indwelling Blood  ODE/DAGID/ARDB                  1126     10/05/01
 Gas Analyzers; Final Guidance for Industry and FDA
Availability of Information Given to Advisory Committee        ODE                             1341     07/18/01
 Members in Connection with CDRH Open Public Panel Meetings;
 Draft Guidance for Industry and FDA Staff
Information for Keratome Manufacturers Regarding LASIK; Final  ODE/DOED/DSDB                   1376     06/21/01
 Guidance for Industry
Changes or Modifications During the Conduct of a Clinical      ODE                             1337     05/29/01
 Investigation; Final Guidance for Industry and CDRH Staff
Class II Special Controls Guidance Document: Tissue Culture    ODE/DRARD/GRDB                  1325     05/16/01
 Media for Human ex vivo Tissue and Cell Culture Processing
 Applications; Final Guidance for Industry and FDA Reviewers
Class II Special Controls Guidance Document: Pharmacy          ODE/DAGID/GHDB                  1326     03/12/01
 Compounding Systems; Final Guidance for Industry and FDA
Class II Special Controls Guidance for Home Uterine Activity   ODE/DRARD/OGDB                   820     03/09/01
 Monitors; Final Guidance for Industry and FDA Reviewers (PDF
 Version Only)
Premarket Approval Applications (PMA) for Sharps Needle        ODE/DAGID/INCB                   891     03/02/01
 Destruction Devices; Final Guidance for Industry and FDA
Early Collaboration Meetings Under the FDA Modernization Act   ODE                              310     02/28/01
 (FDAMA); Final Guidance for Industry and for CDRH Staff
Premarket Applications for Digital Mammography Systems; Final  ODE/DRARD                        983     02/16/01
 Guidance for Industry and FDA
Guidance for Annuloplasty Rings 510(k) Submissions; Final      ODE/DCD/CSPB                    1358     01/31/01
 Guidance for Industry and FDA Staff
Guidance for Industry and FDA Reviewers: Content of            ODE/DRARD/GRDB                  1164     01/16/01
 Investigational Device Exemptions for Solutions for
 Hypothermic Flushing, Transport and Storage of Organs for
 Transplantation
Deciding When To Submit A 510(k) For A Change To An Existing   ODE                             1073     11/30/00
 Wireless Telemetry Medical Device: Final Guidance for FDA
 Reviewers and Industry
Guidance for Cardiopulmonary Bypass Arterial Line Blood        ODE/DCD/CSPB                    1622     11/29/00
 Filter 510(k) Submissions; Final Guidance for Industry and
 FDA
Final Guidance for Industry and FDA: Guidance for              ODE/DCD/CSPB                    1632     11/29/00
 Extracorporeal Blood Circuit Defoamer - 510(k) Submissions
Guidance for Cardiopulmonary Bypass Oxygenators 510(k)         ODE/DCD/CSPB                    1361     11/13/00
 Submissions; Final Guidance for Industry and FDA Staff
Guidance Document for Dura Substitute Devices; Guidance for    ODE/DGRND/PRSB                  1152     11/09/00
 Industry
Investigational Device Exemption (IDE) Study Enrollment for    ODE/DCD/CEMB                    1199     11/08/00
 Cardiac Ablation of Typical Atrial Flutter; Final Guidance
 for Industry and FDA Reviewers
Suggested Format for Developing and Responding to              ODE                             1195     11/02/00
 Deficiencies in Accordance with the Least Burdensome
 Provisions of FDAMA; Final Guidance for Industry and FDA
 Staff
Guidance for Industry and FDA Staff: Guidance Document for     ODE/DCD/PVDB                    1357     11/01/00
 Vascular Prostheses 510(k) Submissions
Guidance for Industry: Guidance for the Submission of          ODE/DCD/PDLB                     372     11/01/00
 Research and Marketing Applications for Permanent Pacemaker
 Leads and for Pacemaker Lead Adaptor 510(k) Submissions
Guidance for Industry and FDA Staff - Class II Special         ODE/DGRND/ORDB                  1193     10/31/00
 Controls Guidance: Shoulder Joint Metal/Polymer/Metal
 Nonconstrained or Semi-Constrained Porous-Coated Uncemented
 Prosthesis
Guidance for Industry: A Suggested Approach to Resolving       ODE                             1188     09/11/00
 Least Burdensome
Guidance for Industry and for FDA Reviewers: Guidance on       ODE                             1135     08/09/00
 Section 216 of the Food and Drug Administration
 Modernization Act of 1997
Guidance for Industry and for FDA Reviewers: Guidance for the  ODE/DRARD/ULDB                  1226     08/09/00
 Content of Premarket Notifications (510(k)s) for
 Extracorporeal Shock Wave Lithotripters Indicated for the
 Fragmentation of Kidney and Ureteral Calculi
Guidance for Industry: Guidance for the Submission of          ODE/DRARD                       1177     08/02/00
 Premarket Notifications for Photon-Emitting Brachytherapy
 Sources
Guidance for Industry: Guidance for the Submission Of          ODE/DRARD                        416     07/27/00
 Premarket Notifications for Medical Image Management Devices
Guidance for Industry and FDA Staff: Guidance on Amended       ODE                              413     07/22/00
 Procedures for Advisory Panel Meetings
Guidance for Industry and CDRH Reviewers: 1-Consolidated       ODE/DCD/PDLB                    1167     07/06/00
 Annual Report for a Device product line (1-CARD)
Guidance for Industry and FDA Reviewers - Class II Special     ODE/DRARD/OGDB                  1144     07/03/00
 Controls Guidance Document for Clitoral Engorgement Devices
Guidance for Industry and FDA Reviewers: Class II Special      ODE/DAGID/ARDB                  1138     07/03/00
 Control Guidance Document for Acute Upper Airway Obstruction
 Devices
Guidance for Industry: Guidance for Premarket Submissions of   ODE/DOED/VEDB                   1134     04/10/00
 Orthokeratology Rigid Gas Permeable Contact Lenses
Guidance for Manufacturers Seeking Marketing Clearance of      ODE/DOED/ENTB                    954     03/12/00
 Ear, Nose, and Throat Endoscope Sheaths Used as Protective
 Barriers: Guidance for Industry
Guidance for Industry and for FDA Staff: Use of Standards in   ODE                             1131     03/12/00
 Substantial Equivalence Determinations
Guidance for Industry and FDA Reviewers - Reprocessing and     ODE/DAGID                       1156     02/08/00
 Reuse of Single-Use Devices
Guidance for Industry and for FDA Reviewers - Guidance         ODE/DAGID/ARDB                  1157     01/24/00
 Document for Premarket Notification Submissions for Nitric
 Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen
 Dioxide Analyzer
Guidance for Industry and for FDA Staff: Guidance for the      ODE/DRARD/ULDB                   177     01/16/00
 Content of Premarket Notifications for Penile Rigidity
 Implants

[[Page 48213]]

Guidance for Industry and/or FDA Staff: Guidance Document for  ODE/DGRND/ORDB                  2250     01/13/00
 the Preparation of IDEs for Spinal Systems
Guidance for Industry and FDA Reviewers: Content and Format    ODE/DAGID/INCB                   397     01/03/00
 of Premarket Notification [510(k)] Submissions for Liquid
 Chemical Sterilants/High Level Disinfectants
ODE Guidance Documents 1998 - 1999
Guidance for Industry and FDA Staff: Guidance for              ODE/DCD/PVDB                      24     11/26/99
 Cardiovascular Intravascular Filter 510(k) Submissions
Guidance for Industry, FDA Reviewers and Compliance on Off-    ODE                              585     09/09/99
 The-Shelf Software Use in Medical Devices
Guidance for Industry and/or for FDA Reviewers/Staff and/or    ODE/DRARD                        644     08/06/99
 Compliance: Guidance for the Submission of 510(k)'s for
 Solid State X-ray Imaging Devices
Guidance for Industry, FDA Reviewers/Staff and Compliance -    ODE/DGRND/REDB                  2246     06/09/99
 Guidance Document for Powered Muscle Stimulator 510(k)s
Recommended Clinical Study Design for Ventricular Tachycardia  ODE/DCD/CEMB                    2244     05/07/99
 Ablation (PDF Version)
Guidance for Industry and for FDA Reviewers/Staff - Guidance   ODE/DOED/ICIB                   1351     03/03/99
 on 510(k) Submissions for Keratoprostheses
Guidance for Industry - Guidance for Dermabrasion Devices      ODE/DGRND/PRSB                  2248     03/02/99
Guidance for Industry and/or for FDA Reviewers/Staff and/or    ODE/DGRND/PRSB                  2247     03/02/99
 Compliance - Guidance for the Preparation of a Premarket
 Notification Application for a Surgical Mesh
Guidance for Industry and FDA Reviewers/Staff: Premarket       ODE/DAGID/INCB                   944     01/13/99
 Notification [510(k)] Submissions for Testing for Skin
 Sensitization To Chemicals In Natural Rubber Products
Guidance for Industry - Guidance for the Submission of         ODE/DRARD                       2240     12/03/98
 Premarket Notifications for Emission Computed Tomography
 Devices and Accessories (SPECT and PET) and Nuclear
 Tomography Systems
Guidance for Industry: Guidance for the Content of Premarket   ODE/DRARD/ULDB                  2235     11/30/98
 Notifications for Intracorporeal Lithotripters
Guidance for Industry - Guidance for the Submission of         ODE/DRARD                       2238     11/20/98
 Premarket Notifications For Radionuclide Dose Calibrators
Guidance for Industry: Non-Automated Sphygmomanometer (Blood   ODE/DCD/CEMB                    2239     11/19/98
 Pressure Cuff) Guidance - Version 1
Guidance for Industry and for FDA Reviewers/Staff: Aqueous     ODE/DOED/ICIB                   2236     11/16/98
 Shunts - 510(k) Submissions
Guidance for Industry - Harmonic Imaging with/without          ODE/DRARD                       2234     11/16/98
 Contrast - Premarket Notification Requirements
Guidance for FDA Reviewers and Industry Medical Devices        ODE                             2206     11/06/98
 Containing Materials Derived from Animal Sources (Except for
 In Vitro Diagnostic Devices)
Guidance for Industry: Guidance for the Submission Of          ODE/DRARD                        340     11/14/98
 Premarket Notifications for Magnetic Resonance Diagnostic
 Devices
Guidance for Industry: Cardiac Monitor Guidance (including     ODE/DCD/PDLB                    2233     11/05/98
 Cardiotachometer and Rate Alarm)
Guidance for Industry: Diagnostic ECG Guidance (Including Non- ODE/DCD/PDLB                    2232     11/05/98
 Alarming ST Segment Measurement)
Guidance for Industry: General/Specific Intended Use           ODE                              499     11/04/98
Guidance for Industry: Frequently Asked Questions on the New   ODE                             2230     10/22/98
 510(K) Paradigm
Guidance for Industry - Noise Claims in Hearing Aid Labeling   ODE/DOED                        2210     10/21/98
Guidance for Industry: Guidance Document For Nonprescription   ODE/DOED/DSDB                   2208     10/09/98
 Sunglasses
Guidance for Industry and FDA Reviewers/Staff: Guidance        ODE/DGRND/GSDB                  2207     09/30/98
 Document for Powered Suction Pump 510(k)s
Guidance for Industry and FDA Reviewers/Staff - Neonatal and   ODE/DAGID/GHDB                  2201     09/18/98
 Neonatal Transport Incubators - Premarket Notifications
Guidance for Industry and FDA Staff: Dental Cements -          ODE/DAGID                       2204     08/18/98
 Premarket Notification
Guidance for Industry and FDA Staff - OTC Denture Cushions,    ODE/DAGID                       2205     08/18/98
 Pads, Reliners, Repair Kits, and Partially Fabricated
 Denture Kits
Guidance for Industry and FDA Staff - Dental Impression        ODE/DAGID                       2203     08/17/98
 Materials Premarket Notification
Guidance for Industry and FDA Staff: Revised Procedures for    ODE/DOED/VEDB                   1249     08/11/98
 Adding Lens Finishing Laboratories to Approved Premarket
 Approval Applications for Class III Rigid Gas Permeable
 Contact Lenses for Extended Wear
Guidance for Industry and CDRH Reviewers: Guidance for the     ODE/DRARD/GRDB                  2202     08/07/98
 Content of Premarket Notifications for Hemodialysis Delivery
 Systems
Guidance for Industry and CDRH Reviewers: Guidance for the     ODE/DRARD/GRDB                   421     08/07/98
 Content of Premarket Notifications for Conventional and High
 Permeability Hemodialyzers
Guidance for Industry: Latex Condoms for Men - Information     ODE/DRARD/OGDB                  1250     07/23/98
 for 510(k) Premarket Notifications: Use of Consensus
 Standards for Abbreviated Submissions
Guidance for Industry - Uniform Contraceptive Labeling         ODE/DRARD/OGDB                  1251     07/23/98
Guidance for Industry, FDA Reviewers/Staff and Compliance:     ODE/DGRND/GSDB                  1244     07/13/98
 Guidance Document for Surgical Lamp 510(k)s
Guidance for Industry: Ophthalmoscope Guidance - (Direct and   ODE/DOED/DSDB                   1241     07/08/98
 Indirect)
Guidance for Industry: Slit Lamp Guidance                      ODE/DOED/DSDB                   1242     07/08/98

[[Page 48214]]

Guidance for Industry: Retinoscope Guidance                    ODE/DOED/DSDB                   1240     07/08/98
Guidance Document For Washers And Washer-Disinfectors          ODE/DAGID/INCB                     4     06/02/98
 Intended For Processing Reusable Medical Devices (Text Only)
Guidance for Industry - Supplements to Approved Applications   ODE                              380     05/20/98
 for Class III Medical Devices: Use of Published Literature,
 Use of Previously Submitted Materials, and Priority Review
 (Text Only)
Guidance For Industry - Guidance For The Content Of Premarket  ODE/DGRND/PRSB                     6     04/28/98
 Notifications For Esophageal And Tracheal Prostheses
The New 510(k) Paradigm - Alternate Approaches to              ODE                              905     03/20/98
 Demonstrating Substantial Equivalence in Premarket
 Notifications - Final Guidance
Guidance on PMA Interactive Procedures for Day-100 Meetings    ODE                              322     02/19/98
 and Subsequent Deficiencies - for Use by CDRH and Industry
30-Day Notices and 135-Day PMA Supplements for Manufacturing   ODE                              795     02/19/98
 Method or Process Changes, Guidance for Industry and CDRH
New Section 513(f)(2) - Evaluation of Automatic Class III      ODE                              199     02/19/98
 Designation, Guidance for Industry and CDRH Staff
Procedures for Class II Device Exemptions from Premarket       ODE                              159     02/19/98
 Notification, Guidance for Industry and CDRH Staff
Guidance For The Content Of Premarket Notifications For Metal  ODE/DRARD/GRDB                  2243     02/05/98
 Expandable Biliary Stents
Guidance on IDE Policies and Procedures                        ODE                              882     01/20/98
Tympanostomy Tubes, Submission Guidance for a 510(k)           ODE/DOED/ENTB                    930     01/14/98
 Premarket Notification; Final (PDF only)
ODE Guidance Documents 1996 - 1997
Distribution and Public Availability of Premarket Approval     ODE                              563     10/10/97
 Application Summary of Safety and Effectiveness Data
 Packages - October 10, 1997 (P97-1) (Text Only)
Notice to Manufacturers of Bone Mineral Densitometers          ODE/DRARD                        552     09/25/97
Discussion Points for Expansion of the ``Checklist of          ODE/DOED/DSDB                   7093     09/05/97
 Information Usually Submitted in an Investigational Device
 Exemption (IDE) Application for Refractive Surgery Lasers''
 Draft Document
Testing for Sensitizing Chemicals in Natural Rubber Latex      ODE/DAGID/INCB                  1944     07/28/97
 Medical Devices (Addendum to 944) (PDF Only)
ORDB 510(K) Sterility Review Guidance                          ODE/DGRND/ORDB                   659     07/03/97
Kit Certification for 510(k)s (Text Only)                      ODE                              562     07/01/97
Guidance for the Content of Premarket Notifications for Water  ODE/DRARD/GRDB                   842     05/30/97
 Purification Components and Systems for Hemodialysis
Convenience Kits Interim Regulatory Guidance                   ODE                              562     05/20/97
Premarket Notification 510(k) Guidance for Contact Lens Care   ODE/DOED/VEDB                    674     05/01/97
 Products (PDF Only)
Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Text      ODE/DCD/CEMB                     123     03/10/97
 Only)
Reviewers Guidance Checklist For Intramedullary Rods           ODE/DGRND/ORDB                   956     02/21/97
Reviewers Guidance Checklist For Orthopedic External Fixation  ODE/DGRND/ORDB                   829     02/21/97
 Devices Version 5
510(K) Information Needed for Hydroxyapatite Coated            ODE/DGRND/ORDB                    47     02/20/97
 Orthopedic Implants
Electrocardiograph (ECG) Electrode (PDF Only)                  ODE/DCD/CEMB                      25     02/11/97
Electrocardiograph (ECG) Lead Switching Adapter (PDF Only)     ODE/DCD/CEMB                      26     02/11/97
Electrocardiograph (ECG) Surface Electrode Tester (PDF Only)   ODE/DCD/CEMB                      27     02/11/97
Guidelines for Reviewing Premarket Notifications that Claim    ODE/DGRND/GSDB                   593     02/01/97
 Substantial Equivalence to Evoked Response Stimulators
Third Party Review Guidance For Vitreous Aspiration & Cutting  ODE/DOED/DSDB                   2196     01/31/97
 Device Premarket Notification (510(k))
Third Party Review Guidance for Phacofragmentation System      ODE/DOED/DSDB                   2197     01/31/97
 Device Premarket Notification (510(k)) (PDF Only)
Deciding When to Submit a 510(k) for a Change to an Existing   ODE                              935     01/10/97
 Device (K97-1)
Guidance for Submitting Reclassification Petition (PDF Only)   ODE                              609     01/01/97
Carotid Stent - Suggestions for Content of Submissions to the  ODE/DCD/PVDB                     974     10/26/96
 Food and Drug Administration in Support of Investigational
 Devices Exemption (IDE) Applications (PDF Only)
Checklist of Information Usually Submitted in an               ODE/DOED/DSDB                   2093     10/10/96
 Investigational Device Exemptions (IDE) Application for
 Refractive Surgery Lasers [excimer]
Letter to Manufacturers of Prescription Home Monitors for Non- ODE/DRARD/OGDB                  1342     09/06/96
 Stress Tests
Letter to Manufacturers of Falloposcopes                       ODE/DRARD/OGDB                  1344     09/05/96
Questions and Answers for the FDA Reviewer Guidance: Labeling  ODE                             1198     09/03/96
 Reusable Medical Devices for Reprocessing in Health Care
 Facilities (PDF Only)
Memorandum of Understanding Regarding Patient Labeling Review  ODE                              806     08/09/96
 (Blue Book Memo G96-3) (Text Only)

[[Page 48215]]

Continued Access to Investigational Devices During PMA         ODE                              872     07/15/96
 Preparation and Review July 15, 1996 (Blue Book Memo) (D96-
 1) (Text Only)
Suggested Format For IDE Progress Report (Text Only)           ODE                              311     06/01/96
Guidance for Testing MR Interaction with Aneurysm Clips,       ODE/DGRND/PRSB                   958     05/22/96
 Draft Document
Guidance Document For Testing Bone Anchor Devices              ODE/DGRND/ORDB                   915     04/20/96
Guidance Document for Testing Biodegradable Polymer Implant    ODE/DGRND/ORDB                   914     04/20/96
 Devices (Text Only)
Labeling Reusable Medical Devices for Reprocessing in Health   ODE                              198     04/01/96
 Care Facilities: FDA Reviewer Guidance (PDF Only)
510(k) Quality Review Program (Blue Book Memo I96-1) (Text     ODE                              344     03/29/96
 Only)
Thermal Endometrial Ablation Devices (Submission Guidance for  ODE/DRARD/OGDB                   547     03/14/96
 an IDE)
Hysteroscopes and Gynecologic Laparoscopes - Submission        ODE/DRARD/OGDB                   907     03/07/96
 Guidance for a 510(k)
Suggested Content for Original IDE Application Cover Letter    ODE                              797     02/27/96
 (Text Only)
Indications for Use Statement                                  ODE                              879     02/06/96
ODE Guidance Documents 1994 - 1995
Guidance On The Content Of Premarket Notification [510(K)]     ODE/DAGID                        993     12/01/95
 Submissions For Protective Restraints (Text Only)
Cover Letter: 510(k) Requirements During Firm-Initiated        ODE                              406     11/21/95
 Recalls; Attachment A: Guidance on Recall and Premarket
 Notification Review Procedures During Firm-Initiated Recalls
 of Legally Marketed Devices (blue book memo K95-1)
 (Text Only)
Addendum to: Guidance on Premarket Notification [510(k)]       ODE/DAGID                       1833     09/19/95
 Submissions for Sterilizers Intended for Use in Health Care
 Facilities (Text Only)
Implementation of the FDA/HCFA Interagency Agreement           ODE                              106     09/15/95
 Regarding Reimbursement Categorization of Investigational
 Devices, Att. A Interagency Agreement, Att. B Criteria for
 Catergorization of Investigational Devices, & Att. C -List
 D95-2 (blue book memo) (Text Only)
HCFA Reimbursement Categorization Determinations for FDA-      ODE                             4106     09/15/95
 approved IDEs (PDF Only)
D95-2, Attachment A (Interagency Agreement between    ODE                             2106     09/15/95
 FDA & HCFA) (PDF Only)
D95-2, Attachment B (Criteria for Categorization of   ODE                             3106     09/15/95
 Investigational Devices (HCFA) (PDF Only)
Hysteroscopic And Laparoscopic Insufflators: Submission        ODE/DRARD/OGDB                  1907     08/01/95
 Guidance For A 510(K) (Text Only)
Guidance Document for the Preparation of Notification          ODE/DGRND/REDB                   818     07/26/95
 (510(k)) Applications for Therapeutic Massagers and
 Vibrators
Guidance Document For the Preparation of Premarket             ODE/DGRND/REDB                   762     07/26/95
 Notification [510(K)] Applications For Communications
 Systems (Powered and Non-Powered) and Powered Environmental
 Control Systems
Guidance Document for the Preparation of Premarket             ODE/DGRND/GSDB                   325     07/26/95
 Notification [510(k)] Applications for Electromyograph
 Needle Electrodes
Guidance Document for the Preparation of Premarket             ODE/DGRND/REDB                   326     07/26/95
 Notification [510(K)] Applications for Exercise Equipment
Guidance Document for the Preparation of Premarket             ODE/DGRND/REDB                   828     07/26/95
 Notification [510(k)] Applications for Heating and Cooling
 Devices
Guidance Document For the Preparation of Premarket             ODE/DGRND/REDB                   729     07/26/95
 Notification [510(K)] Applications For Immersion Hydrobaths
Guidance Document for the Preparation of Premarket             ODE/DGRND/REDB                   735     07/26/95
 Notification [510(k)] Applications for Powered Tables and
 Multifunctional Physical Therapy Tables
Guidance Document for the Preparation of Premarket             ODE/DGRND/REDB                   307     07/26/95
 Notification [510(k)] Applications for Submerged
 (Underwater) Exercise Equipment
Guidance Document for the Preparation of Premarket             ODE/DGRND/REDB                   346     07/26/95
 Notification [510k)] Applications for Mechanical and Powered
 Wheelchairs, and Motorized Three-Wheeled Vehicles
Goals and Initiatives for the IDE Program D95-1       ODE                              405     07/12/95
 (blue book memo) (Text Only)
Draft Reviewer Guidance for Ventilators (PDF Only)             ODE/DAGID/ARDB                   500     07/01/95
Testing guidance for Male Condoms Made from New Material (Non- ODE/DRARD/OGDB                   455     06/29/95
 Latex) (Text Only)
Memorandum: Electromagnetic Compatibility for Medical          ODE                              639     06/13/95
 Devices: Issues and Solutions (PDF Only)
Guidance on the Content and Organization of a Premarket        ODE/DGRND/GSDB                   386     06/01/95
 Notification for a Medical Laser
Guidance Document for Testing Non-Articulating, `Mechanically  ODE/DGRND/ORDB                   916     05/01/95
 Locked', Modular Implant Components
Use of International Standard ISO-10993, `Biological           ODE                              164     05/01/95
 Evaluation of Medical Devices Part 1: Evaluation and
 Testing' (Replaces G87-1 8294) (blue book
 memo) (Text Only)
Guidance on Premarket Notification [510(K)] Submissions for    ODE/DAGID/GHDB                   824     03/15/95
 Short-Term and Long-Term Intravascular Catheters (PDF Only)
Guidance Document For The Preparation of Premarket             ODE/DGRND/ORDB                   355     01/10/95
 Notification For Ceramic Ball Hip Systems
Coronary and Cerebrovascular Guidewire Guidance (PDF Only)     ODE/DCD/ICDB                     964     01/01/95
Checklist for Mechanical Lithotripters and Stone Dislodgers    ODE/DRARD/ULDB                    98     11/01/94
 used in Gastroenterology and Urology (PDF Only)

[[Page 48216]]

510(k) Checklist for Sterile Lubricating Jelly Used With       ODE/DRARD/ULDB                   892     09/19/94
 Transurethral Surgical Instruments (Text Only)
Guidance for the Content of Premarket Notifications for        ODE/DRARD/ULDB                    97     09/12/94
 Conventional and Antimicrobial Foley Catheters (Text Only)
Guidance for the Preparation of a Premarket Notification for   ODE/DGRND/GSDB                   667     08/30/94
 Extended Laparoscopy Devices (ELD)
Guidance For The Content Of Premarket Notifications For        ODE/DRARD/ULDB                   490     07/29/94
 Urodynamic/Uroflowmetry Systems (Text Only)
Premarket Approval Application (PMA) Closure P94-2    ODE                              403     07/08/94
 (blue book memo) (Text Only)
Premarket Notification [510(k)] Guidance Document for Class    ODE/DOED/VEDB                    896     06/28/94
 II Daily Wear Contact Lenses
Guidance for the Content of Premarket Notifications for Urine  ODE/DRARD/ULDB                    96     06/07/94
 Drainage Bags (PDF Only)
510(k) Sign-Off Procedures K94-2 (blue book memo)     ODE                              308     06/01/94
 (Text Only)
Letter to Industry, Powered Wheelchair/Scooter or Accessory/   ODE                              883     05/26/94
 Component Manufacturer from Susan Alpert, Ph.D.,M.D. (PDF
 Only)
510(k) Refuse to Accept Procedures K94-1 (blue book   ODE                              401     05/20/94
 memo) (Text Only)
IDE Refuse to Accept Procedures D94-1 (blue book      ODE                              410     05/20/94
 memo) (Text Only)
Guidance Document for Testing Orthopedic Implants with         ODE/DGRND/ORDB                   827     04/28/94
 Modified Metallic Surfaces Apposing Bone Or Bone Cement
Preamendments Class III Strategy (Text Only)                   ODE                              611     04/19/94
Draft Reviewer Guidance on Face Masks and Shield for CPR (PDF  ODE/DAGID/ARDB                   996     03/16/94
 Only)
Premarket Notification [510(k)] Status Request Form            ODE                              858     03/07/94
Draft 510(K) Submission Requirements for Peak Flow Meters      ODE/DAGID/ARDB                   999     01/13/94
 (PDF Only)
Battery Guidance (PDF Only)                                    ODE/DCD                          873     01/01/94
ODE Guidance Documents 1992 - 1993
Documentation and Resolution of Differences of Opinion on      ODE                              920     12/23/93
 Product Evaluations G93-1 (blue book memo) (Text
 Only)
Excerpts Related to EMI from November 1993 Anesthesiology and  ODE/DAGID/ARDB                   638     11/01/93
 Respiratory Devices Branch (includes EMI standard) (PDF
 Only)
Reviewer Guidance for Nebulizers, Metered Dose Inhalers,       ODE/DAGID/ARDB                   784     10/01/93
 Spacers and Actuators
Guidance on the Content and Format of Premarket Notification   ODE/DAGID/INCB                   895     10/01/93
 [510(k)] Submissions for Sharps Containers (PDF Only)
Guidance on Premarket Notification [510(k)] Submissions for    ODE/DAGID/INCB                   881     08/01/93
 Automated Endoscope Washers, Washer/Disinfectors, and
 Disinfectors Intended for Use in Health Care Facilities (PDF
 Only)
Guidance on Premarket Notification [510(k)] Submissions for    ODE/DAGID/INCB                   888     08/01/93
 Surgical Gowns and Surgical Drapes (PDF Only)
510(k) Additional Information Procedures K93-1 (blue  ODE                              886     07/23/93
 book memo) (Text Only)
Center for Devices and Radiological Health's Investigational   ODE                             4859     06/30/93
 Device Exemption (IDE) Refuse to Accept Policy (PDF Only)
Center for Devices and Radiological Health's Premarket         ODE                             3859     06/30/93
 Notification [510(k)] Refuse to Accept Policy - (updated
 Checklist 3/14/1995) (PDF Only)
Classified Convenience Kits (PDF Only)                         ODE                              789     04/30/93
Draft Emergency Resuscitator Guidance (PDF Only)               ODE/DAGID/ARDB                   985     04/14/93
Guidance on the Content of Premarket Notification [510(K)]     ODE/DAGID/GHDB                   450     04/01/93
 Submissions for Hypodermic Single Lumen Needles (Text Only)
Guidance on the Content of Premarket Notification [510(K)]     ODE/DAGID/GHDB                   821     04/01/93
 Submissions for Piston Syringes (Text Only)
Draft Guidance for Preparation of PMA Applications for         ODE/DRARD/ULDB                   809     03/16/93
 Testicular Prostheses (Text Only)
Guidance on Premarket Notification 510(k) for Sterilizers      ODE/DAGID                        833     03/01/93
 Intended for Use in Health Care Facilities (PDF Only)
Guidance on the Content of Premarket Notification [510(K)]     ODE/DAGID/GHDB                   822     03/01/93
 Submissions for Clinical Electronic Thermometers (Text Only)
Guidance Document for the Preparation of IDE and PMA           ODE/DGRND/ORDB                   233     02/18/93
 Applications for Intra-Articular Prosthetic Knee Ligament
 Devices
Guidance for the Content of Premarket Notifications for        ODE/DRARD/ULDB                   482     02/10/93
 Biopsy Devices Used in Gastroenterology and Urology (Text
 Only)
Guidance for the Content of Premarket Notifications for        ODE/DRARD/ULDB                   431     02/10/93
 Ureteral Stents (Text Only)
Telephone Communications Between ODE Staff and Manufacturers   ODE                              360     01/29/93
 I93-1 (blue book memo) (Text Only)
Policy for Expiration Dating (DCRND RB92-G) (PDF Only)         ODE/DCD                          137     10/30/92
General Guidance Document: Non-Invasive Pulse Oximeter (PDF    ODE/DAGID/ARDB                   997     09/07/92
 Only)
Important Information About Rophae Intraocular Lenses (PDF     ODE/DOED/ICIB                    811     08/20/92
 Only)
Guidance for Peak Flow Meters for Over-the-Counter Sale (PDF   ODE/DAGID/ARDB                   998     06/23/92
 Only)

[[Page 48217]]

SMDA Changes - Premarket Notification; Regulatory              ODE                              655     04/17/92
 Requirements for Medical Devices (510k) Manual Insert (PDF
 Only)
Preamendment Class III Devices (PDF Only)                      ODE                              584     03/11/92
Nondisclosure of Financially Sensitive Information I92-1 (blue book memo) (Text Only)
Document Review Processing I91-1 (blue book memo)     ODE                              446     02/12/92
 (Text Only)
ODE Guidance Documents 1990 - 1991
Heated Humidifier Review Guidance (PDF Only)                   ODE/DAGID/ARDB                   780     08/30/91
Integrity of Data and Information Submitted to ODE I91-2 (blue book memo) (Text Only)
Panel Review of Premarket Approval Applications P91-  ODE                              444     05/03/91
 2 (blue book memo) (Text Only)
PMA Compliance Program P91-3 (blue book memo) (Text   ODE                              445     05/03/91
 Only)
Shelf Life of Medical Devices (PDF Only)                       ODE                              415     04/01/91
Device Labeling Guidance G91-1 (blue book memo)       ODE                              414     03/08/91
 (Text Only)
Consolidated Review of Submissions for Diagnostic Ultrasound   ODE                               30     10/19/90
 Equipment, Accessories and Related Measurement Devices
 G90-2 (blue book memo) (Text Only)
Consolidated Review of Submissions for Lasers and Accessories  ODE                               31     10/19/90
 G90-1 (blue book memo) (Text Only)
Guidance on 510(k) Submissions for Implanted Infusion Ports    ODE/DAGID/GHDB                   392     10/01/90
 (PDF Only)
Assignment of Review Documents I90-2 (blue book       ODE                              366     08/24/90
 memo) (Text Only)
Premarket Testing Guidelines for Female Barrier Contraceptive  ODE/DRARD/OGDB                   384     04/04/90
 Devices also intended to prevent sexually transmitted
 diseases (PDF Only)
Policy Development and Review Procedures I90-1 (blue  ODE                              368     02/15/90
 book memo) (Text Only)
Reviewer Guidance for Automatic X-Ray Film Processor 510(k)    ODE/DRARD                        788     02/01/90
 (PDF Only)
Implantable Pacemaker Testing Guidance (PDF Only)              ODE/DCD/PDLB                     383     01/12/90
Guidance on the CDRH Premarket Notification Review Program 6/  ODE                              390     01/01/90
 30/86 (K86-3)
Threshold Assessment of the Impact of Requirements for         ODE                              352     01/01/90
 Submission of PMAs for 31 Medical Devices Marketed Prior to
 May 28, 1976 (PDF Only)
ODE Guidance Documents 1976 - 1989
Meetings with the Regulated Industry I89-3 (blue      ODE                              367     11/20/89
 book Memo)
Toxicology Risk Assessment Committee G89-1 (blue      ODE                              363     08/09/89
 book memo) (Text Only)
New FDA Recommendations & Results of Contact Lens Study (7     ODE/DOED/VEDB                    265     05/30/89
 day letter) (PDF Only)
Review of IDEs for Feasibility Studies D89-1 (blue    ODE                              362     05/17/89
 book memo) (Text Only)
Premarket Notification - Consistency of Reviews K89-  ODE                              339     02/28/89
 1 (blue Book memo) (Text Only)
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD     ODE/DAGID/ARDB                   583     02/01/89
 868.5905 Non-continuous Ventilator Class II (PDF Only)
Balloon Valvuloplasty Guidance For The Submission Of an IDE    ODE/DCD                          370     01/01/89
 Application and a PMA Application (Text Only)
Guidance for Studies for Pain Therapy Devices - General        ODE/DGRND/REDB                   640     05/12/88
 Consideration in the Design of Clinical Studies for Pain-
 Alleviating Devices
Review of Laser Submissions G88-1 (blue book memo)    ODE                              330     04/22/88
 (Text Only)
Limulus Amebocute Lysate; Reduction of Samples for Testing     ODE                              178     10/23/87
 (PDF Only)
ODE Executive Secretary Guidance Manual G87-3                  ODE                             1338     08/07/87
Master Files Part III; Guidance on Scientific and Technical    ODE                              338     06/01/87
 Information (PDF Only)
Industry Representatives on Scientific Panel (PDF Only)        ODE                              329     03/23/87
Panel Report and Recommendations on PMA Approvals P86-5 (blue book memo) (Text Only)
Points to Consider in the Characterization of Cell Lines Used  ODE                              269     06/01/84
 to Produce Biological Products
Application of the Device Good Manufacturing Practice (GMP)    ODE                              267     12/01/83
 Regulation to the Manufacture of Sterile Devices (PDF Only)
Guidance (`Guidelines') for Evaluation of Hysteroscopic        ODE/DRARD/OGDB                   248     05/10/78
 Sterilization Devices
Guidance (`Guidelines') for Evaluation of Laparoscopic         ODE/DRARD/OGDB                   232     05/01/78
 Bipolar and Thermal Coagulators (and Accessories) (PDF Only)
Guidance (`Guidelines') for Evaluation of Tubal Occlusion      ODE/DRARD/OGDB                   245     11/22/77
 Devices (PDF Only)
Guidance (`Guidelines') for Evaluation of Fetal Clip           ODE/DRARD/OGDB                   244     03/08/77
 Electrode (PDF Only)
Guidelines for Evaluation of Non-Drug IUDs                     ODE/DRARD/OGDB                   641     09/26/76
Review Guidance for Oxygen Generators and Oxygen Equipment     ODE/DAGID/ARDB                   986  ...........
 (PDF Only)
OIVD Guidance Documents
Guidance for Industry and FDA Staff - In Vitro Diagnostic      OIVD                            1706     11/06/09
 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency
Guidance for Industry and FDA Staff - Class II Special         OIVD/DCTD                       1686     10/21/09
 Controls Guidance Document: Cardiac Allograft Gene
 Expression Profiling Test Systems
Guidance for Industry and FDA Staff - Class II Special         OIVD/DMD                        1672     10/09/09
 Controls Guidance Document: Testing for Detection and
 Differentiation of Influenza A Virus Subtypes Using
 Multiplex Assays
Guidance for Industry and FDA Staff - Class II Special         OIVD/DMD                        1673     10/09/09
 Controls Guidance Document: Testing for Human
 Metapneumovirus (hMPV) Using Nucleic Acid Assays
Guidance for Industry and FDA Staff - Class II Special         OIVD/DMD                        1669     10/09/09
 Controls Guidance Document: Respiratory Viral Panel
 Multiplex Nucleic Acid Assay

[[Page 48218]]

Draft Guidance for Industry and FDA Staff - Establishing the   OIVD/DMD                        1699     09/09/09
 Performance Characteristics of In Vitro Diagnostic Devices
 for the Detection or Detection and Differentiation of Human
 Papillomaviruses
Class II Special Controls Guidance Document: Antimicrobial     OIVD/DMD                         631     08/28/09
 Susceptibility Test (AST) Systems
Recommendations for Anti-Nuclear Antibody (ANA) Test System    OIVD/DIHD                        848     01/22/09
 Premarket (510(k)) Submissions
Assay Migration Studies for In Vitro Diagnostic Devices        CBER CDRH/OIVD                  1660     01/05/09
Class II Special Controls Guidance Document: Nucleic Acid      OIVD/DMD                        1665     01/02/09
 Amplification Assay for the Detection of Enterovirus RNA
Class II Special Controls Guidance Document: Plasmodium        OIVD/DMD                        1646     05/20/08
 Species Antigen Detection Assays
Guidance for Industry and FDA Staff: Administrative            OIVD                            1143     05/07/08
 Procedures for CLIA Categorization
Establishing Performance Characteristics of In Vitro           OIVD/DMD                        1638     02/12/08
 Diagnostic Devices for Detection or Detection and
 Differentiation of Influenza Viruses
Recommendations: Clinical Laboratory Improvement Amendments    OIVD                            1171     01/30/08
 of 1988 (CLIA) Waiver Applications for Manufacturers of In
 Vitro Diagnostic Devices
The Review and Inspection of Premarket Approval Application    OIVD OC                         1566     01/08/08
 Manufacturing Information and Operations
Draft Guidance for Industry and FDA Staff - In Vitro           CBER CDRH/OIVD                  1587     10/25/07
 Diagnostic (IVD) Device Studies--Frequently Asked Questions
Guidance for Industry and FDA Staff - Commercially             CBER CDRH/OIVD                  1590     09/14/07
 Distributed Analyte Specific Reagents (ASRs): Frequently
 Asked Questions
Guidance for Industry and FDA Staff - Review Criteria for      OIVD/DIHD                        772     08/08/07
 Assessment of Qualitative Fecal Occult Blood In Vitro
 Diagnostic Devices
Draft Guidance for Industry, Clinical Laboratories, and FDA    CBER CDRH/OIVD                  1610     07/26/07
 Staff - In Vitro Diagnostic Multivariate Index Assays
Guidance on Pharmacogenetic Tests and Genetic Tests for        CBER CDER CDRH                  1549     02/09/06
 Heritable Markers
Guidance for Industry and FDA Staff - Assayed and Unassayed    OIVD                            2231     06/07/07
 Quality Control Material
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1627     05/09/07
 Controls Guidance Document: Gene Expression Profiling Test
 System for Breast Cancer Prognosis
In Vitro Diagnostic Devices to Detect Influenza A Viruses:     OIVD/DMD                        1594     05/01/07
 Labeling and Regulatory Path - Guidance for Industry and FDA
 Staff
Guidance for Industry and FDA Staff - Class II Special         OIVD/DMD                        1305     04/03/07
 Controls Guidance Document: Herpes Simplex Virus Types 1 and
 2 Serological Assays
Statistical Guidance on Reporting Results from Studies         OSB/DB                          1620     03/13/07
 Evaluating Diagnostic Tests
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1614     01/10/07
 Controls Guidance Document: Quality Control Material for
 Cystic Fibrosis Nucleic Acid Assays
Draft Guidance for Industry and FDA Staff - Total Product      OIVD/DCTD                       1603     10/24/06
 Life Cycle for Portable Invasive Blood Glucose Monitoring
 Systems
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1599     07/27/06
 Controls Guidance Document: Fecal Calprotectin Immunological
 Test Systems
Informed Consent for In Vitro Diagnostic Device Studies Using  CBER CDRH                       1588     04/25/06
 Leftover Human Specimens that are Not Individually
 Identifiable
Guidance for Industry and FDA Staff - Class II Special         OIVD/DMD                        1596     03/22/06
 Controls Guidance Document: Reagents for Detection of
 Specific Novel Influenza A Viruses
Guidance for Industry and FDA Staff - Class II Special         OIVD/DMD                        1536     02/09/06
 Controls Guidance Document: Hepatitis A Virus Serological
 Assays
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1564     10/26/05
 Controls Guidance Document: CFTR Gene Mutation Detection
 Systems
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1570     10/04/05
 Controls Guidance Document: AFP-L3 Immunological Test
 Systems
Guidance for Industry - Review Criteria for Assessment of C    OIVD/DCTD                       1246     09/22/05
 Reactive Protein (CRP), High Sensitivity C-Reactive Protein
 (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1563     08/25/05
 Controls Guidance Document: RNA Preanalytical Systems (RNA
 Collection, Stabilization and Purification Systems for RT-
 PCR used in Molecular Diagnostic Testing)
Guidance for Industry and FDA Staff: Format for Traditional    OIVD ODE                        1567     08/12/05
 and Abbreviated 510(k)s
Guidance for the Content of Premarket Submissions for          CBER CDRH/ODE CDRH/OIVD          337     05/11/05
 Software Contained in Medical Devices
Guidance for Industry and FDA Staff - Class II Special         OIVD/DIHD                       1550     03/23/05
 Controls Guidance Document: Automated Fluorescence in situ
 Hybridization (FISH) Enumeration Systems
Class II Special Controls Guidance Document: Instrumentation   OIVD/DCTD                       1546     03/10/05
 for Clinical Multiplex Test Systems - Guidance for Industry
 and FDA Staff
Class II Special Controls Guidance Document: Drug              OIVD/DCTD                       1551     03/10/05
 Metabolizing Enzyme Genotyping System - Guidance for
 Industry and FDA Staff
Guidance for Industry and FDA Staff - Class II Special         OIVD/DCTD                       1301     11/24/04
 Controls Guidance Document: Newborn Screening Test Systems
 for Amino Acids, Free Carnitine, and Acylcarnitines Using
 Tandem Mass Spectrometry
Guidance for Industry and FDA Staff; Class II Special          OIVD/DCTD                       1300     09/30/04
 Controls Guidance Document: Sirolimus Test Systems
Guidance for Third Parties and FDA Staff; Third Party Review   OIVD ODE                        2237     09/28/04
 of Premarket Notifications

[[Page 48219]]

Guidance for Industry and FDA Staff; Class II Special          OIVD/DMD                        1825     09/23/04
 Controls Guidance Document: Serological Assays for the
 Detection of Beta-Glucan
Class II Special Controls Guidance Document: Immunomagnetic    OIVD/DIHD                       1531     05/11/04
 Circulating Cancer Cell Selection and Enumeration System -
 Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Factor V Leiden   OIVD/DIHD                       1236     03/16/04
 DNA Mutation Detection Systems - Guidance for Industry and
 FDA Staff
Guidance for Industry and FDA Staff; Replacement Reagent and   OIVD                             950     12/11/03
 Instrument Family Policy
Premarket Submissions and Labeling Recommendations for Drugs   OIVD/DCTD                        152     12/02/03
 of Abuse Screening Tests - Draft Guidance for Industry and
 FDA Staff
Class II Special Controls Guidance Document: Endotoxin Assay - OIVD/DMD                        1222     10/31/03
  Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Serological       OIVD/DMD                        1206     10/30/03
 Reagents for the Laboratory Diagnosis of West Nile Virus -
 Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Breath Nitric     OIVD/DCTD                       1211     07/07/03
 Oxide Test System - Guidance for Industry and FDA Staff
510(k) Submissions for Coagulation Instruments - Guidance for  OIVD/DIHD                       1223     06/19/03
 Industry and FDA Staff
Premarket Approval Application Filing Review                   CBER CDRH/ODE CDRH/OIVD          297     05/01/03
Determination of Intended Use for 510(k) Devices; Guidance     OIVD ODE                         857     12/03/02
 for CDRH Staff (Update to K98-1)
Class II Special Controls Guidance Document: Cyclosporine and  OIVD/DCTD                       1380     09/16/02
 Tacrolimus Assays; Guidance for Industry and FDA
Class II Special Controls Guidance Document: Premarket         OIVD/DIHD                       1184     12/04/01
 Notifications for Automated Differential Cell Counters for
 Immature or Abnormal Blood Cells; Final Guidance for
 Industry and FDA
Radioallergosorbent Test (RAST) Methods for Allergen-Specific  OIVD/DIHD                        800     08/22/01
 Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry
 and FDA
Class II Special Control Guidance Document for B-Type          OIVD/DCTD                       1072     11/30/00
 Natriuretic Peptide Premarket Notifications; Final Guidance
 for Industry and FDA Reviewers; Final Guidance for Industry
 and FDA Reviewers; Final Guidance for Industry and FDA
 Reviewers
Class II Special Control Guidance Document for Anti-           OIVD/DIHD                       1183     08/23/00
 Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA)
 Premarket Notifications - Guidance for Industry and FDA
 Reviewers
Guidance for Over-the-Counter (OTC) Human Chorionic            OIVD/DCTD                       1172     07/22/00
 Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA
 Reviewers/Staff
Guidance for Labeling for Over-the-Counter Sample Collection   OIVD/DCTD                       1359     12/21/99
 Systems for Drugs of Abuse Testing (PDF Only)
Guidance on Labeling for Laboratory Tests - Draft Guidance     OIVD                            1352     06/24/99
 for Industry and for FDA Reviewers/Staff
Document for Special Controls for Erythropoietin Assay         OIVD/DIHD                       2241     04/28/99
 Premarket Notifications [510(k)s]; Final Guidance for
 Industry
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test;       OIVD/DIHD                       2242     04/27/99
 Final Guidance for Industry and FDA Reviewers/Staff
Abbreviated 510(k) Submissions for In Vitro Diagnostic         OIVD                            1247     02/22/99
 Calibrators; Final Guidance for Industry
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System;    OIVD/DCTD                       1102     07/06/98
 Final Guidance for Industry
In Vitro Diagnostic Chloride Test System; Final Guidance for   OIVD/DCTD                       1103     07/06/98
 Industry
In Vitro Diagnostic Potassium Test System; Final Guidance for  OIVD/DCTD                       1107     07/06/98
 Industry
In Vitro Diagnostic Sodium Test System; Final Guidance for     OIVD/DCTD                       1109     07/06/98
 Industry
In Vitro Diagnostic Urea Nitrogen Test System; Final Guidance  OIVD/DCTD                       1110     07/06/98
 for Industry
In Vitro Diagnostic Glucose Test System; Final Guidance for    OIVD/DCTD                       1105     07/06/98
 Industry
In Vitro Diagnostic Creatinine Test System; Final Guidance     OIVD/DCTD                       1104     07/06/98
 for Industry
Guidance for Submission of Immunohistochemistry Applications   OIVD/DIHD                        364     06/03/98
 to the FDA; Final Guidance for Industry
Review Criteria For Assessment Of Rheumatoid Factor (Rf) In    OIVD/DIHD                        165     02/21/97
 Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay
 (Eia), Enzyme Linked Immunosorbent Assay (Elisa), Particle
 Agglutination Tests, And Laser And Rate Nephelometry
Review Criteria for Assessment of Professional Use Human       OIVD/DCTD                       1345     11/06/96
 Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices
 (IVDs)
Review Criteria for Assessment of Antimicrobial                OIVD/DMD                        1631     10/30/96
 Susceptibility Test Discs (PDF Only)
Guidance Document for the Submission of Tumor Associated       OIVD/DIHD                        957     09/19/96
 Antigen Premarket Notifications, [510(k)], to FDA
Points to Consider for Portable Blood Glucose Monitoring       OIVD/DCTD                        122     02/20/96
 Devices Intended for Bedside Use in the Neonate Nursery (PDF
 Only)
Review Criteria for In Vitro Diagnostic Devices that Utilize   OIVD/DIHD                        980     02/15/96
 Cytogenetic In Situ Hybridization Technology for the
 Detection of Human Genetic Mutations (Germ Line and Somatic)
Review Criteria Assessment of Portable Blood Glucose           OIVD/DCTD                        604     02/28/97
 Monitoring In Vitro Diagnostic Devices Using Glucose
 Oxidase, Dehydrogenase or Hexokinase Methodology
Points to Consider for Review of Calibration and Quality       OIVD                             553     03/14/96
 Control Labeling for In Vitro Diagnostic Devices/Cover
 Letter dated 3/14/1996 (PDF Only)
Guidance for 510(k)s on Cholesterol Tests for Clinical         OIVD/DCTD                        605     07/13/95
 Laboratory, Physicians' Office Laboratory and Home Use
Points to Consider for Collection of Data in Support of In-    OIVD                              95     09/26/94
 Vitro Device Submissions for 510(k) Clearance (PDF Only)
Points to Consider for Cervical Cytology Devices (PDF Only)    OIVD/DIHD                        968     07/25/94
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in   OIVD/DIHD                        459     07/15/94
 vitro Diagnostic Devices for Fetal Open Neural Tube Defects
 Using Immunological Test Methodologies (PDF Only)

[[Page 48220]]

Review Criteria for In Vitro Diagnostic Devices for the        OIVD/DIHD                         51     02/01/94
 Assessment of Thyroid Autoantibodies using Indirect
 Immunofluorescence Assay (IFA), Indirect Hemagglutination
 Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked
 Immunosorbent Assay (ELISA)
Guideline for the Manufacture of In Vitro Diagnostic Products  OIVD                             918     01/10/94
 (PDF only)
Review Criteria for Assessment of In Vitro Diagnostic Devices  OIVD/DMD                         862     07/06/93
 for Direct Detection of Mycobacterium Spp. [Tuberculosis
 (TB)] (PDF Only)
Review Criteria for Assessment of Laboratory Tests for the     OIVD/DMD                         588     09/17/92
 Detection of Antibodies to Helicobacter pylori (PDF Only)
Draft Guidance Document for 510(k) Submission of               OIVD/DIHD                        785     09/01/92
 Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro
 Devices (PDF Only)
Review Criteria for In Vitro Diagnostic Devices for Detection  OIVD/DIHD                        527     08/01/92
 of IGM Antibodies to Viral Agents (PDF Only)
Review Criteria For Premarket Approval of In Vitro Diagnostic  OIVD/DMD                         770     05/15/92
 Devices for Detection of Antibodies to Parvovirus B19 (PDF
 Only)
Review Criteria for Devices Intended for the Detection of      OIVD/DMD                         554     12/30/91
 Hepatitis B `e' Antigen and Antibody to HBe (PDF Only)
Review Criteria for Assessment of Glycohemoglobin (Glycated    OIVD/DIHD                        658     09/30/91
 or Glycosylated) Hemoglobin In Vitro Diagnostic Devices
 (Text Only)
Draft Guidance for 510(k) Submission of Lymphocyte             OIVD/DIHD                        475     09/26/91
 Immunophenotyping IVDs using Monoclonal Antibodies (PDF
 Only)
Review Criteria for Blood Culture Systems (PDF Only)           OIVD/DIHD                         82     08/12/91
Review Criteria for Assessment of Cytogenetic Analysis Using   OIVD/DIHD                        417     07/15/91
 Automated and Semi-Automated Chromosome Analyzers (Text
 Only)
Review Criteria for Devices Assisting in the Diagnosis of C.   OIVD/DMD                         629     05/31/90
 Difficile Associated Diseases (PDF Only)
Assessing the Safety and Effectiveness of Home-Use In Vitro    OIVD                             272     10/05/88
 Diagnostic Devices (IVDs): Draft Points to Consider
 Regarding Labeling and Premarket Submissions (Text Only)
Office of Surveillance and Biometrics Guidance Documents
Draft Guidance for Industry, User Facilities and FDA Staff:    OSB/DPS                         1679     08/21/09
 eMDR - Electronic Medical Device Reporting
Procedures for Handling Post-Approval Studies Imposed by PMA   OSB/DPS                         1561     06/16/09
 Order
Statistical Guidance on Reporting Results from Studies         OSB/DB                          1620     03/13/07
 Evaluating Diagnostic Tests
Guidance for the Use of Bayesian Statistics in Medical Device  OSB/DB                          1601     02/05/10
 Clinical Trials
Postmarket Surveillance Under Section 522 of the Federal       OSB                              316     04/26/06
 Food, Drug and Cosmetic Act
Hospital Bed System Dimensional and Assessment Guidance to     OSB/DPS OCER/DHC                1537     03/10/06
 Reduce Entrapment
Needlesticks - Medical Device Reporting Guidance for User      OSB/DSS/RSMB                     250     11/12/02
 Facilities, Manufacturers, and Importers
Medical Device Reporting - Remedial Action Exemption;          OSB/DSS/RSMB                     188     09/26/01
 Guidance for FDA and Industry
Hospital Reprocessors: Guidance on Adverse Event Reporting     OSB/DSS/RSMB                    1334     04/24/01
 for Hospitals that Reprocess Devices Intended by the
 Original Equipment Manufacturer for Single Use
MEDWATCH Medical Device Reporting Code Instructions            OSB/DSS                          853     04/04/01
Medical Device Reporting - Alternative Summary Reporting       OSB/DSS/RSMB                     315     10/19/00
 (ASR) Program
Guidance for Industry and for FDA Reviewers/Staff - Guidance   OSB/DPS                          946     02/02/00
 for Industry on the Testing of Metallic Plasma Sprayed
 Coatings on Orthopedic Implants to Support Reconsideration
 of Postmarket Surveillance Requirements
SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing  OSB/DPS                          318     11/02/98
 Postmarket Surveillance Protocols
Instructions for Completing Form 3417 - Medical Device         OSB/DSS                         1061     07/01/96
 Reporting Baseline Report
Variance from Manufacturer Report Number Format - No. 5        OSB/DSS                  ...........     08/12/96
MDR Guidance Document No. 1 - IOL - E1996004                   OSB/DSS                          216     08/06/96
Variance from Manufacturer Report Number Format [MDR letter]   OSB/DSS                         1059     07/16/96
Medical Device Reporting: An Overview                          OSB/DSS                          509     04/01/96
Statistical Guidance for Clinical Trials of Non Diagnostic     OSB                              476     01/01/96
 Medical Devices
MedWatch: The FDA Safety Information and Adverse Event         .......................  ...........     01/01/09
 Reporting Program -
Common Problems: Baseline Reports and MedWatch Form 3500A      OSB/DSS                          379  ...........
 (letter to manufacturers updated) (PDF version)
Perspectives on Clinical Studies for Medical Device            OSB                               78  ...........
 Submissions (PDF Only)
PMA Review Statistical Checklist (PDF Only)                    OSB                               84  ...........
Office of Science and Engineering Laboratories Guidance
 Documents
Draft Guidance for Industry and FDA Staff: Clinical            OSEL/DIAM                       1698     10/21/09
 Performance Assessment: Considerations for Computer-Assisted
 Detection Devices Applied to Radiology Images and Radiology
 Device Data - Premarket Approval (PMA) and Premarket
 Notification [510(k)] Submissions
Draft Guidance for Industry and FDA Staff: Computer-Assisted   OSEL/DRARD/RDB                  1697     10/21/09
 Detection Devices Applied to Radiology Images and Radiology
 Device Data - Premarket Notification [510(k)] Submissions
Guidance for Industry and FDA Staff - Information for          OSEL ODE/DRARD                   560     09/09/08
 Manufacturers Seeking Marketing Clearance of Diagnostic
 Ultrasound Systems and Transducers
Establishing Safety and Compatibility of Passive Implants in   OSEL                            1685     08/21/08
 the Magnetic Resonance (MR) Environment
Guidance for Industry and FDA Staff - Class II Special         OSEL ODE/DRARD                  1547     07/17/08
 Controls Guidance Document: Bone Sonometers

[[Page 48221]]

Draft Guidance for Industry and FDA Staff: Class II Special    OSEL ODE/DRARD                  1616     05/30/08
 Controls Guidance Document: Full Field Digital Mammography
 System
Guidance for Industry and FDA Staff: Display Accessories for   OSEL ODE/DRARD                  1617     05/30/08
 Full-Field Digital Mammography Systems-Premarket
 Notification (510(k)) Submissions
CDRH Standard Operating Procedures for the Identification and  OSEL                             616     09/17/07
 Evaluation of Candidate Consensus Standards for Recognition
Frequently Asked Questions on Recognition of Consensus         OSEL                             109     09/17/07
 Standards
Guidance for Industry and FDA Staff - Recognition and Use of   OSEL                             321     09/17/07
 Consensus Standards
Radio-Frequency Wireless Technology in Medical Devices         OSEL/DPS/EPB                    1618     01/03/07
Dental Curing Lights - Premarket Notification [510(k)]         OSEL/DPS ODE/DAGID/DEDB         1591     03/27/06
Immunotoxicity Testing Guidance                                OSEL                             635     05/06/99
Guidance on FDA's Expectations of Medical Device               OSEL/DECS                       2000     05/15/98
 Manufacturers Concerning the Year 2000 Date Problem
A Primer on Medical Device Interactions with Magnetic          OSEL                             952     02/07/97
 Resonance Imaging Systems
----------------------------------------------------------------------------------------------------------------

V. Center for Food Safety and Applied Nutrition (CFSAN)

    For information on a specific guidance document or to obtain a 
paper copy, call the contact number located on the title page of the 
guidance. You may access electronic versions of CFSAN's guidance 
documents at http://www.fda.gov/FoodGuidances, http://www.fda.gov/
CosmeticGuidances, and http://www.fda.gov/ColorAdditiveGuidances.
    The following is a list of CFSAN guidance documents that have been 
withdrawn:

------------------------------------------------------------------------
                                            Date of          Date of
           Title of Document                Issuance        Withdrawal
------------------------------------------------------------------------
Release of Task Force Report; Guidance  July 10, 2003    January 16,
 for Industry and FDA: Interim                            2009
 Evidence-Based Ranking System for
 Scientific Data; Withdrawal of
 Guidance
------------------------------------------------------------------------
Guidance for Industry; Importer's       1985             May 29, 2009
 Guide for Low-Acid Canned and
 Acidified Food
------------------------------------------------------------------------
Guidance for Industry: Significant      December 22,     January 16,
 Scientific Agreement in the Review of   1999             2009
 Health Claims for Conventional Foods
 and Dietary Supplements; Withdrawal
 of Guidance
------------------------------------------------------------------------
Guidance for Industry on the Food and   January 22,      April 25, 2008
 Drug Administration Recommendations     2001
 for Sampling and Testing Yellow Corn
 and Dry-Milled Yellow Corn Shipments
 Intended for Human Food Use for Cry9C
 Protein Residues; Withdrawal of
 Guidance
------------------------------------------------------------------------

    The following is a list of current CFSAN guidance documents as of 
May 13, 2010:

Biotechnology Safety Assessments
   Statement of Policy & Guidance to Industry: Foods Derived from New Plant Varieties (57 FR 22984, May
   29, 1992)
   Consultation Procedures under FDA's 1992 Statement of Policy: Foods Derived from New Plant Varieties
   (October 1997)
   Draft Guidance: Use of Antibiotic Resistance Marker Genes in Transgenic Plants (September 1998)
   Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New
   Plant Varieties Intended for Food Use (June 2006)
Chemical Contaminants and Pesticides
   Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (2000)
Chemical Contaminants
   Arsenic: Bottled Water: Arsenic Small Entity Compliance Guide (April 2009)
   Disinfectants: Bottled Water: Residual Disinfectants and Disinfection Byproducts Small Entity
   Compliance Guide (May 2009)
   Lead: 1991 Letter to Bureau of Alcohol, Tobacco and Firearms Regarding Lead in Wine (March 2007)
   Lead: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and
   Enforcement Policy (November 2006)
   Lead: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers (June
   13, 1995)
   Uranium: Bottled Water: Uranium Small Entity Compliance Guide (April 2009)
Pesticides
   Pesticide Chemicals: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals,
   for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency
   Pursuant to Dietary Risk Considerations (May 2005)
   Methyl Parathion: Channels of Trade Policy for Commodities with Methyl Parathion Residues (December
   2000)
   Vinclozolin: Channels of Trade Policy for Commodities with Vinclozolin Residues (June 12, 2002)
Also see Natural Toxins
   Fumonisin Levels in Human Foods and Animal Feeds (November 9, 2001)
Dietary Supplements
   Liquid Dietary Supplements: Factors that Distinguish Liquid Dietary Supplements from Beverages,
   Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods (December
   2009)

[[Page 48222]]

   Labeling: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the
   Dietary Supplement and Nonprescription Drug Consumer Protection Act (December 2007; Revised December 2008 and
   September 2009)
   A Dietary Supplement Labeling Guide (April 2005)
   Ephedrine Alkaloids: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids
   Adulterated Because They Present an Unreasonable Risk (July 17, 2008)
   Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small
   Entity Compliance Guide (October 17, 2003)
   Labeling: Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements
   Small Entity Compliance Guide (January 1999)
   Nutrient Content Claims: Food Labeling; Nutrient Content Claims; Definition for ``High Potency'' and
   Definition for ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional
   Foods Small Entity Compliance Guide (July 2008)
   Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
   Substantiation for Claims: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6)
   of the Federal Food, Drug, and Cosmetic Act (November 2004)
Health Claims
   Evidence-Based Review System for the Scientific Evaluation of Health Claims (January 2009)
   Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a
   Scientific Body (June 1998)
Qualified Health Claims
   Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human
   Dietary Supplements (July 10, 2003)
Adverse Events Reporting
   Adverse Event Reporting and Recordkeeping: Questions and Answers Regarding Adverse Event Reporting
   and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug
   Consumer Protection Act (June 2009)
Food Defense and Emergency Response
Emergency Response
   Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory
   (May 2010)
Prior Notice of Food Imports
   Compliance Policy Guide - Guidance for FDA and CBP Staff: Prior Notice of Imported Food (May 2009)
   Entry Types and Entry Identifiers - Prior Notice of Imported Food (April 7, 2005)
   Prior Notice of Imported Food Contingency Plan for System Outages (August 12, 2004)
   Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004)
   What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003; Revised April
   2009)
   Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators
   (August 26, 2004)
Registration of Food Facilities
   Questions and Answers Regarding Registration of Food Facilities (Edition 4) (August 6, 2004)
   Compliance Policy Guide - Guidance for FDA Staff: Registration of Food Facilities Under the Public
   Health Security and Bioterrorism Preparedness and Response Act of 2002 (December 2003; Revised November 2004
   and August 2006)
   Necessity of the Use of Food Product Categories in Registration of Food Facilities (July 17, 2003)
   What You Need to Know About Registration of Food Facilities (November 25, 2003)
Establishment and Maintenance of Records
   Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4) (September 21,
   2006)
   Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health
   Security and Bioterrorism Preparedness and Response Act of 2002 (November 2005)
   What You Need to Know About Establishment and Maintenance of Records (December 2004)
Administrative Detention
   What You Need to Know About Administrative Detention of Foods (November 2004)
Food and Cosmetic Security Preventive Measures Guidance
   Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance (October 2007)
   Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance
   (October 2007)
   Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food
   Security Preventive Measures Guidance (October 2007)
   Importers and Filers: Food Security Preventive Measures Guidance (October 2007)
   Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance (October
   2007)
ALERT
   Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training
   (February 22, 2007)
Food Ingredients and Packaging
Petition Process for Food and Color Additives
   Electronic Submissions
    [cir] Regulatory Submissions: Providing Regulatory Submissions in Electronic Format or Paper Format to the
     Office of Food Additive Safety (Draft Guidance, March 2010).
    [cir] Providing Regulatory Submissions in Electronic Format--General Considerations (Agency) (Draft
     Guidance, October 2003)
    [cir] Providing Food and Color Additive Petitions in Electronic Format (Draft, July 2001)
    [cir] Submission Form - FDA Form 3503 (PDF - 256KB)
   Preparing Petitions
    [cir] Pre-Petition Consultations for Food Additives and Color Additives for the Preparation of Petition
     Submissions (April 2005)
    [cir] Questions And Answers About the Food Additive Petition Process (September 2003; Revised April 2006)
   Food Additives
    [cir] Guidance for Food Additive Petition Expedited Review (January 1999)
Preparation of Notifications for Food Contact Substances (Food Contact Notifications (FCN))
   Preparation of Food Contact Notifications: Administrative (June 2000; Revised May 2002)
    [cir] FDA Form 3480 - Notification for New Use of a Food Contact Substance (PDF - 1031KB)
    [cir] FDA Form 3479 - Notifications for Food Contact Formulation (PDF-583KB)
Threshold of Regulation (TOR) Guidance
   Guidance for Submitting Requests under 21 CFR 170.39, Threshold of Regulation for Substances Used in
   Food Contact Articles (March 1996; Revised April 2005)
GRAS Notices

[[Page 48223]]

   Frequently Asked Questions about GRAS (December 2004)
Scientific Guidance Documents
Chemistry Guidance Documents
   Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances:
   Chemistry Recommendations (April 2002; Revised December 2007)
   Use of Recycled Plastics in Food Packaging: Chemistry Considerations (August 2006)
   Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions
   (March 2006; Revised March 2009)
   Estimating Dietary Intake of Substances in Food (September 1995; Revised August 2006)
   Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions,
   January 1993.
Microbiology
   Guidance for Antimicrobial Food Additives (July 1999)
   Microbiological Considerations for Antimicrobial Food Additive Submissions (June 2008)
Toxicology Guidance Documents
   Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations
   (September 1999; April 2002)
   Summary Table of Recommended Toxicological Testing for Additives Used in Food (1983; Revised June
   2006)
   Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used
   in Food
    [cir] Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used
     in Food (also known as Redbook I), U.S. Food and Drug Administration, Bureau of Foods (now CFSAN), 1982.
     May be purchased from: National Technical Information Services (NTIS), 5285 Port Royal Road, Springfield,
     VA 22161, Telephone (703) 605-6000, NTIS Order Number PB83-170696.
    [cir] Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives: 1993
     Draft Redbook II. Sections of Draft Redbook II not yet finalized in Redbook 2000 are available.
    [cir] Toxicological Principles for the Safety Assessment of Food Ingredients: Redbook 2000 (July 7, 2000;
     Revised October 2001, November 2003, April 2004, February 2006, and July 2007)
     (Redbook 2000 chapters now substitute for or supplement guidance available in the 1982 Redbook I and in the
     1993 Draft Redbook II, which can be obtained from the Office of Food Additive Safety. Additional chapters
     of Redbook 2000 will become available electronically upon their completion.)
   Templates for reporting toxicology data (March 2004; April 2005)
Environmental Guidance Documents
   Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the
   Center for Food Safety and Applied Nutrition (May 2006)
  When testing is necessary, consult the Environmental Assessment Technical Assistance Handbook for testing
   guidelines.
   Environmental Assessment Technical Assistance Handbook (September 2003; Revised May 2006)
 Please contact the Environmental Review Group at Premarkt@fda.hhs.gov for assistance in preparing a claim of
 categorical exclusion or an EA and before doing environmental fate and effects testing.
Color Additives Guidance Documents
   Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and
   Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices (January 1997; Revised
   July 2009)
   Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food
   Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses (May 2006)
Food Labeling & Nutrition
General
   A Food Labeling Guide (April 2008)
   Retail Labeling: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-
   Home Foods (April 2008)
   Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims;
   Small Entity Compliance Guide (August 20, 2003)
   Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993)
   Food Allergens: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling
   and Consumer Protection Act of 2004 (Edition 4) (October 2006)
   Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996)
   Guidance for Industry: Ingredients Declared as Evaporated Cane Juice; Draft Guidance (October 2009)
Nutrition Labeling
   Small Business Nutrition Labeling Exemption (October 1, 2004; Updated May 7, 2007)
   FDA Nutrition Labeling Manual--A Guide for Developing and Using Data Bases (March 1998)
Label Claims
   Letter Regarding Point of Purchase Food Labeling (October 2009)
   Dear Manufacturer Letter Regarding Front-of-Package Symbols (December 2008)
   Dear Manufacturer Letter Regarding Food Labeling (January 2007)
   Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a
   Scientific Body (July 1998)
   Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
   Nutrient Content Claims: Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)
   Nutrient Content Definitions: Food Labeling; Nutrient Content Claims; Definition for ``High Potency''
   and Definition for ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and
   Conventional Foods Small Entity Compliance Guide (July 2008)
Health Claims
   Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human
   Dietary Supplements (July 10, 2003)
   FDA's Implementation of ``Qualified Health Claims'': Questions and Answers (May 12, 2006)
   Evidence-Based Review System for the Scientific Evaluation of Health Claims (January 2009)
   Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary
   Supplements (December 1999)
   Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (May
   2009)
Specific Products
   Beer: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug
   Administration; Draft Guidance (August 2009)
   Juice: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively
   Achieving a 5-Log Pathogen Reduction (October 7, 2002)
   Milk: Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated
   with Recombinant Bovine Somatropin (59 FR 6279, February 10, 1994)

[[Page 48224]]

   Shell Eggs: Food Labeling - Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell
   Eggs Held for Retail Distribution Small Entity Compliance Guide (July 2001)
   Soy Lecithin: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section
   403(w) of the Federal Food, Drug, and Cosmetic Act (April 2006)
   White Chocolate: Standard of Identity for White Chocolate; Small Entity Compliance Guide (July 17,
   2008)
   Whole Grain: Draft Guidance: Whole Grain Label Statements (February 2006)
   Biotechnology: Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been
   Developed Using Bioengineering (January 2001)
   Irradiation: Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L.
   No. 107-171, Sec.   10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods
   that Have Been Treated by Irradiation. (October 2002)
   Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small
   Entity Compliance Guide (October 17, 2003)
   Refrigeration: Guidance on Labeling of Foods that Need Refrigeration by Consumers (62 FR 8248,
   February 24, 1997)
   Serving Size: Food Labeling - Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin;
   Small Entity Compliance Guide (July 2001)
Color Additive Guidance
   Guidance for Industry: Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods
   and Cosmetic Products That Contain These Color Additives; Small Entity Compliance Guide (April 2009)
Food Processing & HACCP
   Food Processing: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods
   (February 2008)
   Juice
    [cir] Juice HACCP Hazards and Control Guidance - First Edition (March 3, 2004)
    [cir] Juice HACCP Small Entity Compliance Guide (April 4, 2003)
    [cir] Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (June 2003)
   Seafood
    [cir] Fish and Fisheries Products Hazards and Control Guide 3rd Edition (June 2001)
    [cir] Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of
     Fish and Fishery Products (July 2001)
    [cir] Seafood HACCP Transition Policy (December 1999)
Food Safety
   Guidance for Industry: Sanitary Transportation of Food (April 2010)
   Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic
   Portal as Established by the Food and Drug Administration Amendments Act of 2007 March 2010
   Guidance for Industry Questions and Answers Regarding the Reportable Food Registry as Established by
   the Food and Drug Administration Amendments Act of 2007 June 2009; Revised September 2009
Imports & Exports
   Establishing and Maintaining a List of U. S. Dairy Product Manufacturers/Processors with Interest in
   Exporting to Chile (June 22, 2005)
   Importers and Filers: Food Security Preventive Measures Guidance (October 2007)
   Draft Guidance: Regulatory Procedures Manual Chapter 9, Subchapter: Guidance Concerning Recommending
   Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned (November
   5, 2002)
   Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy Wrappers (June 13,
   1995)
Prior Notice of Imported Foods
   Prior Notice of Imported Food Questions and Answers (Edition 2) (May 3, 2004)
   What You Need to Know About Prior Notice of Imported Food Shipments (November 25, 2003; Revised April
   2009)
Infant Formula
Frequently Asked Questions about FDA's Regulation of Infant Formula (March 1, 2006)
Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants June 1988
Guidelines Concerning Notification and Testing of Infant Formulas 1985
Juice
   Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007)
   Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and
   Untreated Juice and Cider (September 22, 2005)
   Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction
   Purposes (November 2004)
   Juice HACCP Hazards and Control Guidance - First Edition (March 3, 2004)
   The Juice HACCP Regulation: Questions and Answers (September 4, 2003)
   Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (June 2003)
   Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices (April 24, 2003)
   Juice HACCP Small Entity Compliance Guide (April 4, 2003)
   Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a
   5-Log Pathogen Reduction (October 7, 2002)
   The Juice HACCP Regulation: Questions & Answers (August 31, 2001)
Medical Foods
   Frequently Asked Questions About Medical Foods (May 1997; Revised May 2007)
Natural Toxins
   Letter to State Agricultural Directors, State Feed Control Officials, and Food, Feed, and Grain Trade
   Organizations (September 16, 1993)
   Fumonisin Levels in Human Foods and Animal Feeds (November 2001)
Related Guidance
   CPG Sec.510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with
   Patulinhttp://edocket.access.gpo.gov/2010/pdf/2010-12638.pdf
   October 2001; Updated November 2005
Produce and Plant Products Guidance for Industry
Produce
   Guide to Minimize Microbial Food Safety Hazards of Tomatoes (July 2009)
   Guide to Minimize Microbial Food Safety Hazards of Melons (July 2009)
   Guide to Minimize Microbial Food Safety Hazards of Leafy Greens (July 2009)
   Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (October 26, 1998)
   (Also available in French, Spanish, Portuguese and Arabic*)

[[Page 48225]]

   Final Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables
   (February 2008)
   Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999)
   Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production (October 1999)
Nuts
   Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-
   Derived Product As An Ingredient (June 2009)
   Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-
   Derived Product as an Ingredient (March 2009)
Retail Food Protection
   Decontamination of Transport Vehicles: A Notice from the Food and Drug Administration to Growers,
   Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of
   Transport Vehicles (October 7, 2005; Revised August 2006)
   Food Defense: Retail Food Stores and Food Service Establishments: Food Security Preventive Measures
   Guidance (December 2003; Revised October 2007)
   Labeling of Shell Eggs: Food Labeling: Safe Handling Statements, Labeling of Shell Eggs;
   Refrigeration of Shell Eggs Held for Retail Distribution, Small Entity Compliance Guide (July 2001)
Sanitation
   Defect Action Levels (DALS) (1995; Revised March 1997 and May 1998)
  Booklet. This list is compiled from FDA's Compliance Policy Guides on established ``current levels for natural
   or unavoidable defects in food for human use that present no health hazards.''
   Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (2000)
Seafood
   1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as
   Part of the Weight of Frozen Seafood (February 2009)
   Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric
   Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to
   the European Union and the European Free Trade Association (January 2009; Revised February 2009)
   Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of
   Fish and Fishery Products (July 2001)
   Fish and Fisheries Products Hazards and Control Guide 3rd Edition (June 2001)
    [cir] Updated Information: Letter to Seafood Processors that Purchase Grouper, Amberjack, and Related
     Predatory Reef Species Captured in the Northern Gulf of Mexico (February 2008)
   HACCP Regulation for Fish and Fishery Products; Questions and Answers for Guidance to Facilitate the
   Implementation of a HACCP System in Seafood Processing (Issue Three, January 1999)
   Seafood HACCP Transition Policy (December 1999)
   Proposed Referral Program from the Food and Drug Administration to the National Oceanic and
   Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and
   Fishery Products for Export to the European Union and the European Free Trade Association (November 2004)
   Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t))
   Regarding the Use of the Term ``Catfish'' (December 2002)
   Guidance and Protocol: Certification of Fish and Fishery Products for Export to the European Union
   and the European Free Trade Association (January 2008)
Small Entity Compliance Guides
   Submission of Comments for CFSAN Rulemaking (October 2002)
   Booklets Available on Bioterrorism Act of 2002 Legislation
    [cir] What You Need to Know About Registration of Food Facilities (November 2003)
    [cir] What You Need to Know About Prior Notice of Imported Food Shipments (November 2003; Revised April
     2009)
    [cir] What You Need to Know About Establishment and Maintenance of Records (December 2004)
    [cir] What You Need to Know About Administrative Detention of Foods (November 2004)
   Food Labeling
    [cir] Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (August 20, 2003)
    [cir] Small Business Nutrition Labeling Exemption (October 2004; Revised May 2007)
    [cir] Food Labeling - Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for
     Retail Distribution (July 2001)
    [cir] Food Labeling - Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin (July 2001)
    [cir] Food Labeling; Nutrient Content Claims; Definition for ``High Potency'' and Definition for
     ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (July
     2008)
    [cir] Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (May
     2009)
   Food Standards: Standard of Identity for White Chocolate (July 17, 2008)
   Dietary Supplements
    [cir] Iron-Containing Supplements and Drugs: Label Warning Statements (October 17, 2003)
    [cir] Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They
     Present an Unreasonable Risk (July 17, 2008)
    [cir] Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements (January
     1999)
    [cir] Structure/Function Claims (January 9, 2002)
   Shell Eggs: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and
   Storage (April 2010)
   Juice: Juice HACCP (April 4, 2003)
   Bottled Water
    [cir] Bottled Water: Total Coliform and E. coli (March 2010)
    [cir] Bottled Water: Residual Disinfectants and Disinfection Byproducts (May 2009)
    [cir] Bottled Water: Arsenic (April 2009)
    [cir] Bottled Water: Uranium (April 2009)
Color Additive Guidance
   Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and Cosmetic Products
   That Contain These Color Additives (April 2009)
   Petitions
    [cir] Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition
     for Color Additives Used in or on Contact Lenses (May 2006)

[[Page 48226]]

    [cir] Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on
     Color Additives for Food, Drugs, Cosmetics, or Medical Devices (January 1997; Revised July 2009)
Cosmetic Guidance
   Guidance: Labeling for Cosmetics Containing Alpha Hydroxy Acids (January 10, 2005)
   Guidance for Industry: Cosmetics Processors and Transporters of Cosmetics Security Preventive
   Measures Guidance (November 2003; Revised October 2007)
   Cosmetic Labeling Manual (October 1991)

VI. Center for Tobacco Products (CTP)

    For information on a specific guidance document or to obtain a 
paper copy contact:
    Document Control Center, Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, e-mail: 
TobaccoIndustryQuestions@fda.hhs.gov, http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
    The following list of current CTP guidance documents was obtained 
from FDA's Web site on April 22, 2010:

 Final Guidance for Industry: Tobacco Health Document Submission
 Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco
 Product Establishments
 Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with
 Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act
 Final Guidance for Industry: Listing of Ingredients in Tobacco Products
 Draft Guidance for Industry: Preliminary Timetable for the Review of Applications for Modified Risk
 Tobacco Products under the Federal Food, Drug, and Cosmetic Act
 Guidance for Industry: Timeframe for Submission of Tobacco Health Documents
 Guidance to Industry and FDA Staff: General Questions and Answers on the Ban of Cigarettes that Contain
 Certain Characterizing Flavors (Edition 2)

VII. Center for Veterinary Medicine (CVM)

    For information on a specific guidance document or to obtain a 
paper copy, contact:
    Communications Staff, Center for Veterinary Medicine, Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9300, 
e-mail: AskCVM@fda.hhs.gov, http://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm.
    The following list of CVM guidance documents that have been 
withdrawn was obtained from FDA's Web site on April 22, 2010:

                      Withdrawn/Replaced Guidances
------------------------------------------------------------------------
    No.                      Title                           Date
------------------------------------------------------------------------
1           Anticoccidial Guidelines                 Replaced by
                                                      Guideline #40
------------------------------------------------------------------------
2            Anthelmintics                           Withdrawn 12/22/
                                                      2004
------------------------------------------------------------------------
4           Guidelines for Efficacy Studies for      Withdrawn 12/22/
             Systemic Sustained Release Sulfonamide   2004
             Boluses for Cattle
------------------------------------------------------------------------
8           Guidelines for Toxicological             Replaced by
             Investigations                           Guideline # 3
------------------------------------------------------------------------
9           Preclearance Guidelines for Production   Withdrawn pending
             Drugs                                    revisions
------------------------------------------------------------------------
14          Guideline and Format for Reporting the   Withdrawn 12/22/
             Details of Clinical Trials Using An      2004
             Investigational New Animal Drug in
             Food Producing Animals
------------------------------------------------------------------------
15          Guideline and Format for Reporting the   Withdrawn 12/22/2
             Details of Clinical Trials Using An
             Investigational New Animal Drug in Non-
             Food Producing Animals (2277)
------------------------------------------------------------------------
17          Working Guidelines for Assigning         Replaced by
             Residue Tolerances                       Guideline # 3
------------------------------------------------------------------------
18          Antibacterial Drugs in Animal Feeds:     Withdrawn 12/22/
             Human Health Safety Criteria             2004
------------------------------------------------------------------------
19          Antibacterial Drugs in Animal Feeds:     Withdrawn 12/22/
             Animal Health Safety Criteria            2004
------------------------------------------------------------------------
20          Antibacterial Drugs in Animal Feeds:     Withdrawn 12/22/
             Antibacterial Effectiveness Criteria     2004
------------------------------------------------------------------------
21          Nutritional Ingredients in Animal Drugs  Withdrawn 9/17/2009
             and Feeds
------------------------------------------------------------------------
25          Guidelines for the Efficacy Evaluation   Replaced by
             of Equine Anthelmintics                  Guidance 109
------------------------------------------------------------------------
26          Guidelines for the Preparation of Data   (superceded by
             to Satisfy the Requirements of Section   Guidance #61) 04/
             512 of the Act Regarding Animal          86;
             Safety, Effectiveness, Human Food
             Safety and Environmental
             Considerations for Minor Use of New
             Animal Drugs
------------------------------------------------------------------------
27          New Animal Drug Determinations           Withdrawn 9/17/2009
------------------------------------------------------------------------

[[Page 48227]]

28          Animal Drug Applications Expedited       Withdrawn 10/14/
             Review Guideline                         2009
------------------------------------------------------------------------
29          Guidelines for the Effectiveness         Replaced by
             Evaluation of Swine Anthelmintics        Guidance 110
------------------------------------------------------------------------
30          Guidelines for Anti-infective Bovine     Replaced by
             Mastitis Product Development             guideline #49
------------------------------------------------------------------------
31          Guideline for the Evaluation of Bovine   Replaced by
             Anthelmintics                            guideline #95
------------------------------------------------------------------------
32          Guideline for Threshold Assessment       Replaced by
                                                      Guideline # 3
------------------------------------------------------------------------
33          Target Animal Safety Guidelines for New  Withdrawn,
             Animal Drugs                             superceded by #85
                                                      4/24/09
------------------------------------------------------------------------
34          Biomass Guideline - Guideline for New    Replaced by
             Animal Drugs and Food Additives          Guideline # 3
             Derived From a Fermentation; Human
             Food Safety Evaluation
------------------------------------------------------------------------
36          Guidelines for Efficacy Evaluation of    Replaced by
             Canine/Feline Anthelmintics              Guidance # 111
------------------------------------------------------------------------
39          Guideline on the Conduct of Clinical     replaced by
             Investigations: Responsibilities of      Guidance # 85
             Clinical Investigators and Monitors
             for Investigational New Animal Drug
             Studies
------------------------------------------------------------------------
41          Draft Guideline: Formatting,             Withdrawn 3/2002
             Assembling, and Submitting New Animal
             Drug Applications
------------------------------------------------------------------------
43          Draft Guideline for Generic Animal Drug  Withdrawn 05/24/06
             Products Containing Fermentation-
             Derived Drug Substances
------------------------------------------------------------------------
51          Points to Consider Guideline -           ``Please see
             Development of a Pharmacokinetic         Guidance 66 for
             Guideline Enabling Flexible Labeling     updated
             of Therapeutic Antimicrobials            information.''
------------------------------------------------------------------------
52          Assessment of the Effects of             Replaced by
             Antimicrobial Drug Residues from Food    Guidance 159
             of Animal Origin on the Human
             Intestinal Flora, February 18, 2004
------------------------------------------------------------------------
54          Draft Guideline for Utility Studies for  06/94 See Final
             Anti-Salmonella Chemical Food            Guidance #80
             Additives in Animal Feeds
------------------------------------------------------------------------
58          Guidance for Industry for Good Target    Withdrawn 12/22/
             Animal Study Practices: Clinical         2004; superseded
             Investigators and Monitors               by guidance #85
------------------------------------------------------------------------
60          Guidance For Industry: Animal Proteins   Replaced by
             Prohibited From Animal Feed; Small       Guidance 67, 68,
             Entity Compliance Guide                  69, and 70
------------------------------------------------------------------------
66          Withdrawal of Guidance Document on       Withdrawn 01/30/200
             Professional Flexible Labeling of
             Antimicrobial Drugs
------------------------------------------------------------------------
77          Guidance for Industry: Interpretation    Withdrawn 06/12/03
             of On-Farm Feed Manufacturing and
             Mixing Operations:
------------------------------------------------------------------------
78          Consideration of the Human Health        Replaced by
             Impact of the Microbial Effects of       Guidance 152
             Antimicrobial New Animal Drugs
             Intended for Use in Food-Producing
             Animals
------------------------------------------------------------------------
154         Draft Guidance for Industry: 21 CFR      Withdrawn 02/25/03
             Part 11; Electronic Records;
             Electronic Signatures, Maintenance of
             Electronic Records
------------------------------------------------------------------------
155         Draft Guidance for Industry: 21 CFR      Withdrawn 02/04/03
             Part 11: Electronic Records;
             Electronic Signatures; Electronic
             Copies of Electronic Records
------------------------------------------------------------------------
172         Guidance for Industry 172 -     Withdrawn 07/15/04
             Use of unapproved hormone implants in
             veal calves, April 2, 2004
------------------------------------------------------------------------

    The following list of current CVM guidance documents was obtained 
from FDA's Web site on April 22, 2010:

3        CVM GFI 3 General Principles for Evaluating the Safety of Compounds Used in Food     07/27/06
          Producing Animals
5        CVM GFI 5 Stability Guidelines                                                       12/01/90
6        CVM GFI 6 Submitting NADA's for Generic Drugs Reviewed by NAS/NR                     03/19/76
10       CVM GFI 10 Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines        10/01/75
13       CVM GFI 13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice    01/01/85
          Feeds-Medicated Block
22       CVM GFI 22 Guideline Labeling of Arecoline Base Drugs Intended for Animal Use        .........
23       CVM GFI 23 Medicated Free Choice Feeds--Manufacturing Control                        07/01/85
24       CVM GFI 24 Drug Combinations for Use in Animals                                      10/01/83
35       CVM GFI 35 Bioequivalence Guidance                                                   11/08/06
37       CVM GFI 37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed   03/01/84
          for Pigmentation

[[Page 48228]]

38       CVM GFI 38 Guideline for Effectiveness Evaluation of Topical/Otic Animal Drugs       03/01/84
40       CVM GFI 40 Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drug  04/01/92
          Combinations in Poultry
42       CVM GFI 42 Animal Drug Manufacturing Guidelines- Series of Four Guidelines           01/01/94
45       CVM GFI 45 Guideline for Uniform Labeling of Drugs for Dairy and Beef Cattle         08/01/93
48       CVM GFI 48 Submission Documentation for Sterilization Process Validation in          11/01/94
          Applications for Human and Veterinary Drug Products
49       CVM GFI 49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial    04/01/96
          Bovine Mastitis Products (Lactating and Non-Lactating Cow Products)
50       CVM GFI 50 Target Animal and Human Food Safety,Drug Efficacy, Environmental and      02/01/93
          Manufacturing Studies for Teat Antiseptic Products
53       CVM GFI 53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic        05/01/94
          Animals
55       CVM GFI 55 Supportive Data for Cat Food Labels Bearing ``Reduces Urinary pH Claims:  06/01/94
          Protocol Development
56       CVM GFI 56 Protocol Development Guideline for Clinical Effectiveness and Target      07/10/01
          Animal Safety Trials
57       CVM GFI 57 Preparation and Submission of Veterinary Master Files                     01/01/95
59       CVM GFI 59 How to Submit a Notice of Claimed Investigational Exemption in            06/15/09
          Electronic Format to CVM
61       CVM GFI 61 FDA Approval of New Animal Drugs for MUMS                                 05/29/08
62       Consumer-Directed Broadcast Advertisements                                                    .........
63       VICH GL1 - Validation of Analytical Procedures: Definition and Terminology                    07/01/99
64       VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance                   07/01/99
         Industry-Supported Scientific and Educational Activites                                       .........
67       CVM GFI 67 Small Entities Compliance Guide for Renderers                             02/01/98
68       CVM GFI 68 Small Entities Compliance Guide for Protein Blenders, Feed                02/01/98
          Manufacturers, and Distributors
69       CVM GFI 69 Small Entities Compliance Guide for Feeders of Ruminant Animals with On-  02/01/98
          Farm Feed Mixing Operations
70       CVM GFI 70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without   07/13/09
          On-Farm Feed Mixing Operations
72       CVM GFI 72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be    05/01/98
          Licensed with FDA
73       VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances                             11/21/07
74       VICH GL4 - Stability Testing of New Veterinary Dosage Forms                                   05/01/99
75       VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and      05/01/99
          Medicinal Products
76       CVM GFI 76 Questions and Answers BSE Feed Regulations                                01/01/98
79       CVM GFI 79 Dispute Resolution Procedures for Science-Based Decisions on Products     07/01/05
          Regulated by CVM
80       CVM GFI 80 Evaluation the Utility of Anti-Salmonella Chemical Food Additives         11/21/02
82       CVM GFI 82 Development of Supplemental Applications for Approved New Animal Drugs    10/28/02
83       CVM GFI 83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA      05/30/07
84       GFI 84- Product Name Placement, Size, and Prominence in                              .........
85       VICH GL9 - Good Clinical Practices                                                            05/09/01
86       CVM GFI 86 How to Submit a Notice of Final Disposition of Investigational Animals    06/15/09
          Not Intended for Immediate Slaughter in Electronic Format to CVM
87       CVM GFI 87 How to Submit a Notice of Intent to Slaughter for Human Food Purpose in   06/15/09
          Electronic Format to CVM
88       CVM GFI 88 How to Submit a Request for a Meeting or Teleconference in Electronic     06/15/09
          Format to CVM
89       VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I                                  03/07/01
90       VICH GL7 - Effectiveness of Anthelmintics: General Recommendations                            10/11/01
91       VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal       03/01/00
          Products on Stability Testing for Medicated Premixes
92       VICH GL10(R) - Impurities In New Veterinary Drug Substances                                   11/21/07
93       VICH GL11(R) - Impurities in New Veterinary Medicinal Products                                11/21/07
95       VICH GL12 - Efficacy of Anthelmintics: Specific Recommendations for Bovines                   03/26/01
96       VICH GL13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines                    03/26/01
97       VICH GL14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines                  03/26/01
98       CVM GFI 98 Dioxin In Anti-Caking Agents In Animal Feed And Feed Ingredients          04/12/00
99       VICH GL17 - Testing of New Biotechnological/Biological Products                               03/26/01
100      VICH GL18 Residual Solvents in New Veterinary Medicinal Products                              05/15/01
102      CVM GFI 102 Manufacture and Distribution of Unapproved Piperazine Products           08/27/99
103      GFI 103 - Possible Dioxin/PCB Contamination of Drug and Biological Products          .........
104      CVM GFI 104 Content and Format of Effectiveness and Target Animal Safety Technical   07/10/01
          Sections and Final Study Reports For Submission
105      GFI 105 - Computerized Systems Used in Clinical Investigations                       .........
106      CVM GFI 106 Published Literature in Support of New Animal Drug Approval              08/31/00
107      CVM GFI 107 How to Submit a Protocol without Data in Electronic Format to CVM        06/15/09
108      CVM GFI 108 Submit Information using the FDA Electronic Submission Gateway           06/15/09
109      VICH GL15 - Specific Recommendations for Equine                                               06/27/02
110      VICH GL16 - Specific Recommendations for Porcine                                              06/27/02
111      VICH GL19- Specific Recommendations for Canine                                                06/27/02
112      GFI 112 - Fumonisin Levels in Human Foods and Animal Feeds; Final Guidance           .........
113      VICH GL20 - Specific Recommendations for Feline                                               06/19/02
114      VICH GL21 - Specific Recommendations for Poultry-Gallus Gallus                                06/19/02
115      VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies    07/27/06
116      VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:     07/27/06
          Genotoxicity Testing
117      VICH GL24 - Management of Adverse Event Reports (AER's)                                       05/01/06
118      CVM GFI 118 Mass Spectrometry for Confirmation of Identity of Animal Drug Resides    05/01/03
119      CVM GFI 119 How CVM Intends to Handle Deficient Submissions Filed During the         08/29/02
          Investigation of a New Animal Drug
120      CVM GFI 120 Veterinary Feed Directive Regulation                                     03/26/09
121      CVM GFI 121 Expedited Review for NADA for Human Pathogen Reduction Claims            03/06/01
122      CVM GFI 122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive     11/09/04
          Noncompanion Carnivores and Omnivores
123      CVM GFI 123 Development of Data Supporting Approval of NSAIDS for Use in Animal      01/05/06

[[Page 48229]]

124      GFI 124 - Voluntary Labeling Indicating Whether Foods Have or Have Not Been          .........
          Developed Using Bioengineering
126      CVM GFI 126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives          06/01/06
          Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
132      CVM GFI 132 The Administrative New Animal Drug Application Process                   11/06/02
135      CVM GFI 135 Validation of Analytical Procedures for Type C Medicated Feeds           11/07/05
136      CVM GFI 136 Method Transfer Studies for Type C Medicated Feed Assay Methods          04/26/07
137      CVM GFI 137 Analytical Methods Description for Type C Medicated Feeds                05/08/07
141      VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:     07/27/06
          Carcinogenicity Testing,
142      VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic        12/12/01
          Summary Update Reports (PSUs)
143      VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms      06/20/07
144      VICH GL27 - Pre-Approval for Registration of New VMPs for Food-Producing Animals to           04/27/04
          Antimicrobial Resistance
145      GFI 145 -Bioanalytical Method Validation                                             .........
147      VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food      11/12/03
          Repeat Dose (90 Day) Toxicity Testing
148      VICH GL32 - Developmental Toxicity Testing                                                    07/27/06
149      VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:     03/17/09
          General Approach to Testing
150      CVM GFI 150 Concerns Related to the use of Clove Oil as an Anesthetic for Fish       04/24/07
151      GFI 151 - FDA Export Certificates                                                    .........
152      CVM GFI 152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to   10/23/03
          Their Microbiological Effects on Bacteria of Human Health Concern
153      CVM GFI 153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants  09/01/02
          for Use in Humans and Animals
156      CVM GFI 156 Comparability Protocols-Chemistry, Manufacturing, and Controls           02/01/03
          Information
157      GFI 157 -Part 11, Electronic Records;Electronic Signatures-Scope and Application     .........
158      CVM GFI 158 Use of Material from Deer and Elk in Animal Feed                         09/15/03
159      VICH GL36 - Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General        08/30/06
          Approach to Establish a Microbiological ADI
160      VICH GL37 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:     07/27/06
          Repeat-Dose (Chronic) Toxicity Testing
162      GFI 162 - Comparability Protocols -Protein Drug Products and Biological Products     .........
          CMC
163      CVM GFI 163 Scientific and Technical Issues Related to Pharmaceutical CGMP           08/25/03
164      GFI 164 - PAT -Framework for Innovative Pharmaceutical Development,                  .........
          Manufacturing,and Quality Assurance
165      CVM GFI 165 Providing Regulatory Submissions in Electronic Format                    10/01/03
166      VICH GL38 - EIA's for Veterinary Medicinal Products, Phase II                                 01/09/06
167      GFI 167 - Prior Notice of Imported Food; Q&A's                                       .........
168      GFI 168 -Harmonized Tariff Schedule Codes Flagged with Prior Notice Indicators       .........
169      CVM GFI 169 Drug Substance: Chemistry, Manufacturing, and Controls Information       06/01/06
170      CVM GFI 170 Animal Drug User Fees and Fee Waivers and Reductions                     10/01/08
171      CVM GFI 171 Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in    10/06/08
          Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
173      CVM GFI 173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)      02/07/05
173      CVM GFI 173 Appendix for the Animal Drug Sponsor Fees Under the (ADUFA)              02/07/05
174      CVM GFI 174 Use of Material from BSE Positive Cattle in Animal Feed                  09/30/04
176      VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug   06/14/06
          Substances and New Medicinal Products: Chemical Substances
177      VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological           06/14/06
          Veterinary Medicinal Product
178      CVM GFI 178 Design/Evaluation of Effectiveness Studies - Swine Respiratory Disease   10/01/07
          Claims
179      CVM GFI 179 Use of Animal Clones and Clone Progeny for Human Food/Animal Feed        01/15/08
181      CVM GFI 181 Blue Bird Medicated Feed Labels                                          04/10/08
182      VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission  05/01/06
          of Adverse Event Reports
183      CVM GFI 183 ADUFA- Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction         03/09/07
185      VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products                       04/24/09
187      CVM GFI 187 Regulation of Genetically Engineered Animals Containing Heritable        01/15/09
          Recombinant DNA Constructs
190      GFI 190 -Container and Closure System Integrity Testing in Lieu of Sterility         .........
          Testing as a Component of the Stability Protocol for Sterile Products
191      CVM GFI 191 New NADAs vs. Category II Supplemental NADAs                             11/19/09
192      CVM GFI 192 Anesthetics for Companion Animals                                        03/25/10
193      GFI 193 -Providing Regulatory Submissions in Electronic Format--Drug Establishment   .........
          Registration and Drug Listing
194      GFI 194 -Submission of Documentation in Applications for Parametric Release of       .........
          Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
196      CVM GFI 196 Process Validation: General Principles and Practices                     11/08/08
195      CVM GFI 195 Small Entities Compliance Guide For Renderers--Substances Prohibited     05/06/09
          From Use In Animal Food Or Feed
197      CVM GFI 197 Documenting Statistical Analysis Programs and Data Files                 04/30/09
198      VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug     07/21/09
          Substances and Medicinal Products
199      CVM GFI 199 - Animal Generic Drug User Fees and Fee Waivers and Reductions           05/13/09
205      VICH GL46 - Metabolism Study to Determine the Quantity and Identify the Nature of Residues    04/09/10
206      VICH GL47 - Comparative Metabolism Studies In Laboratory Animals                              04/09/10
207      VICH GL48 - Marker Residue Depletion Studies to Establish Product Withdrawal Periods          04/09/10
208      VICH GL49 - Validation of Analytical Methods Used in Residue Depletion Studies                04/09/10
Sub Chapter 600 - Veterinary Drugs
   CPG Sec. 605.100 - Use of Statements Regarding NADA Approval by FDA in Labeling and Advertising of
   New Animal Drugs
   CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary
   Devices

[[Page 48230]]

   CPG Sec. 608.100 Human-Labeled Drugs Distributed and Used in Animal Medicine (Withdrawn 7/7/2006)
   CPG Sec. 608.200 Over-The-Counter Sale of Injectable Animal Drugs
   CPG Sec. 608.300 Lay Use of *Animal Capture and Euthanasia* Drugs
   CPG Sec. 608.400 Compounding of Drugs for Use in Animals
   CPG Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority for
   *Warning* Letter Issuance
   CPG Sec. 615.100 Extra Label Use of New Animal Drugs in Food Producing Animals - Revoked on 09/24/
   1998 (63 FR 51074)
   CPG Sec 615.115 Extra-Label Use of Medicated Feeds for Minor Species
   CPG Sec. 615.200 Proper Drug Use and Residue Avoidance by Non-Veterinarians
   CPG Sec. 615.300 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs
   CPG Sec. 616.100 Streptomycin Residues in Cattle Tissues (Withdrawn 7/7/2006)
   CPG Sec. 625.200 Availability of Bulk Chemicals for Animal Drug Use
   CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct
   Reference Seizure Authority
   CPG Sec.625.400 Reconditioning of New Animal Drugs Seized Under Section 501 (a)(5)
   CPG Sec. 625.500 Failure to Register *and/or Drug List*
   CPG Sec. 625.600 Orders for Post-Approval Record Reviews
   CPG Sec. 634.100 Drugs Packaged for Infusion or Injection of Food-Producing Animals
   CPG Sec. 635.100 Large Volume Parenterals (LVP's) for Animal Use
   CPG Sec. 637.100 Plastic Containers for Injectable Animal Drugs
   CPG Sec. 638.100 Process Validation Requirements for Drug Products Subject to Pre-Market Approval
   CPG Sec. 640.100 Anthelmintics
   CPG Sec. 641.100 *Products for Control of Fleas and Ticks* Containing a Pesticide
   CPG Sec. 642.100 *Drugs for Odor Control and Conception in Pet Animals*
   CPG Sec. 643.100 Oral Iron Products for Baby Pigs
   CPG Sec. 645.100 Biological Drugs for Animal Use
   CPG Sec. 650.100 Animal Drugs for Euthanasia
   CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (Revised 05/01/2000)
   CPG Sec. 653.100 Animal Grooming Aids
   CPG Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use
   CPG Sec. 654.200 Teat Dips and Udder Washes for Dairy Cows and Goats
   CPG Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure
   Authority
   CPG Sec. 655.100 Devices for Use in Animals
   CPG Sec. 655.200 Adequate Directions for Use - Animal Drugs & Veterinary Devices
   CPG Sec. 655.300 Barking Dog Collar
   CPG Sec. 655.400 The Status of Syringes and Needles for Animal Use
Sub Chapter 660 - Animal Feed
   CPG Sec. 660.100 Failure to Register
   CPG Sec. 665.100 Common or Usual Names for Animal Feed Ingredients
   CPG Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds
   CPG Sec. 665.300 Use of Type A Medicated Article Brand Names in Feed Labels
   CPG Sec. 666.100 Alternate Feeding of Different Medicated Feeds
   CPG Sec. 670.100 Refusals of Formula Information During Inspection of Feed Mills Manufacturing Feeds
   Requiring Approved Medicated Feed Applications
   CPG Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated
   Feed
   CPG Sec. 670.500 Ammoniated Cottonseed Meal - Interpretation of 21 CFR
   CPG Sec. 675.100 Diversion of Contaminated Food for Animal Use
   CPG Sec. 675.200 Diversion of Adulterated Food to Acceptable Animal Feed Use
   CPG Sec. 675.300 Moisture Damaged Grain
   CPG Sec. 675.400 Rendered Animal Feed Ingredients
   CPG Sec. 680.100 Tracers in Animal Feed
   CPG Sec. 680.200 CGMP Regulations for Medicated Feeds - Daily Inventory Requirements
   CPG Sec. 680.400 Medicated Feeds--Combined Batches
   CPG Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover
   CPG Sec. 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production,
   Storage, and Distribution of Feeds
   CPG Sec. 681.100 Order for Post-Approval Record Reviews
   CPG Sec. 682.100 Use of Drug-Contaminated Products in Animal Feed
   CPG Sec. 682.200 The Use of Antibiotic Drug Residue By-Products in Animal Feed Feed
   CPG Sec. 683.100 Action Levels for Aflatoxins in Animal Feeds
   CPG Sec. 685.100 Recycled Animal Waste
   CPG Sec. 687.500 Silage Ingredients
   CPG Sec. 688.100 Unapproved Additives for Exported Grains
   CPG Sec. 689.100 Direct-Fed Microbial Products
   CPG Sec. 690.100 Nutritional Supplements for Companion Animals
   CPG Sec. 690.200 Pet Food Labeling
   CPG Sec. 690.300 Canned Pet Food
   CPG Sec. 690.400 Water and Gravy in Pet Food
   CPG Sec. 690.500 Uncooked Meat for Animal Food
   CPG Sec. 690.600 Rodent Contaminated Pet Foods - *Direct Reference Seizure Authority*
   CPG Sec. 690.700 Salmonella Contamination of Dry Dog Food

VII. Office of the Commissioner

    For information on a specific guidance document or to obtain a 
paper copy, please go to FDA's Web site: http://www.fda.gov/
RegulatoryInformation/Guidances/Default.htm.
    The following list of current OC guidance documents was obtained 
from FDA's Web site on April 26, 2010:

[[Page 48231]]

FDA Guidance Documents: General and Cross-Cutting Topics
   03/2001 Acceptance of Foreign Clinical Studies
   01/2009 Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions:
   Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug
   Administration Amendments Act of 2007
   12/2006 Complementary and Alternative Medicine Products and their Regulation by the Food and Drug
   Administration
   08/1999 Consumer-Directed Broadcast Advertisements
   02/2008 Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of
   the Stability Protocol for Sterile Products
   11/1997 Direct Final Rule Procedures
   08/2003 Part 11, Electronic Records; Electronic Signatures--Scope and Application
   11/2002 Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records (PDF -
   143KB)
   09/2001 (247) 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Draft
   Guidance for Industry (PDF - 117KB)
   09/2001 (246) 21 CFR Part 11; Electronic Records; Electronic Signatures,Validation; Draft Guidance
   for Industry (PDF - 202KB)
   07/2007 Emergency Use Authorization of Medical Products
   03/2003 FDA Issues Food and Cosmetic Security Preventive Measures Guidance
   05/2004 Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV
   01/2009 Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or
   Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical
   Devices
   11/1997 Industry Supported Scientific and Educational Activities (PDF - 428KB)
   10/2003 Guidance for Industry - Providing Regulatory Submissions in Electronic Format--General
   Considerations
   03/2010 Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for
   Prescription Drug Packages
   01/2009 Submission Of Laboratory Packages By Accredited Laboratories
   09/1997 The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine
   Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use
   03/2006 Using Electronic Means to Distribute Certain Product Information
   01/2009 Voluntary Third-Party Certification Programs for Foods and Feeds
Advisory Committee Guidance Documents
   03/2010 Public Availability of Advisory Committee Members' Financial Interest Information and Waivers
   - Draft Guidance (PDF - 59KB)
   08/2008 Preparation and Public Availability of Information Given to Advisory Committee Members -
   Final Guidance - August 1, 2008 (PDF - 169KB)
   08/2008 Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA
   Advisory Committees - Final Guidance - August 1, 2008 (PDF - 106KB)
   08/2008 Public Availability of Advisory Committee Members' Financial Interest Information and Waivers
   - Final Guidance - August 1, 2008 (PDF - 55KB)
   08/2008 Voting Procedures at Advisory Committee Meetings - Final Guidance - August 1, 2008 (PDF -
   37KB)
   08/2008 When FDA Convenes an Advisory Committee - Draft Guidance - August 1, 2008 (PDF - 40KB)
   02/2005 The Open Public Hearing - FDA Advisory Committee Meetings - Draft Guidance
Clinical Trials Guidance Documents
   01/2010 IRB Continuing Review After Clinical Investigation Approval - Draft Guidance (PDF - 125KB)
   07/2009 Frequently Asked Questions - IRB Registration (PDF - 48KB)
   09/2005 Collection of Race and Ethnicity Data in Clinical Trials
   01/1988 Monitoring Clinical Investigations
   04/1999 Computerized Systems Used in Clinical Trials
   01/2006 Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF -
   121KB)
   01/1998 Institutional Review Boards Frequently Asked Questions - Information Sheet
   01/1998 Cooperative Research - Information Sheet
   01/1998 Non-local IRB Review - Information Sheet
   01/1998 Continuing Review After Study Approval - Information Sheet
   01/1998 Sponsor - Investigator - IRB Interrelationship - Information Sheet
   01/1998 Acceptance of Foreign Clinical Studies - Information Sheet
   01/1998 Charging for Investigational Products - Information Sheet
   01/1998 Recruiting Study Subjects - Information Sheet
   01/1998 Payment to Research Subjects - Information Sheet
   01/1998 Screening Tests Prior to Study Enrollment - Information Sheet
   01/1998 A Guide to Informed Consent - Information Sheet
   01/1998 Use of Investigational Products When Subjects Enter a Second Institution - Information Sheet
   01/1998 Exception from Informed Consent for Studies Conducted in Emergency Settings: Regulatory
   Language and Excerpts from Preamble - Information Sheet
   01/1998 ``Off-Label'' and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices -
   Information Sheet
   09/2008 Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Information Sheet
   (PDF - 71KB)
   01/1998 Emergency Use of an Investigation Drug or Biologic - Information Sheet
   01/1998 Treatment Use of Investigational Drugs - Information Sheet
   Waiver of IRB Requirements for Drug and Biological Product Studies - Information Sheet (PDF - 35KB)
   01/1998 Drug Study Designs - Information Sheet
   01/1998 Evaluation of Gender Differences in Clinical Investigations - Information Sheet
   01/2006 FDA Inspections of Clinical Investigators - Information Sheet (PDF - 48KB)
   01/2006 FDA Institutional Review Board Inspections - Information Sheet (PDF - 45KB)
   01/2007 FDA/NCI MOU Regarding Common Standards-based Data Repository (PDF - 312KB)
   Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human
   Subject Protection
   01/2009 Adverse Event Reporting to IRBs - Improving Human Subject Protection (PDF - 79KB)
   12/2006 Process for Handling Referrals to FDA under 21 CFR 50.54 (PDF - 76KB)
   03/2006 Establishment and Operation of Clinical Trial Data Monitoring Committees (PDF - 194KB)
   07/2004 Available Therapy
   03/2005 Development and Use of Risk Minimization Action Plans (PDF - 84KB)
   03/2001 Financial Disclosure by Clinical Investigators
   12/2002 Food-Effect Bioavailability and Fed Bioequivalence Studies (PDF - 166KB)

[[Page 48232]]

   03/2005 Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
   07/1993 Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of
   Drugs (PDF - 1875KB)
   05/2004 Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability
   (PDF - 166KB)
   01/2004 IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment
   of Cancer (PDF - 188KB)
   03/2002 Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
   Conditions (PDF - 34KB)
   10/2003 IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations (PDF - 614KB)
   08/2003 Electronic Records; Electronic Signatures - Part 11, Scope and Application (PDF - 215KB)
   01/2002 General Principles of Software Validation
   03/2005 Pharmacogenomic Data Submissions (PDF - 96KB)
   03/2005 Premarketing Risk Assessment (PDF - 91KB)
   10/2005 Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product
   Applications and Related Submissions Using the eCTD Specifications
   09/2004 The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 33KB)
   03/2006 Using a Centralized IRB Review Process in Multicenter Clinical Trials
   04/2006 Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that
   are Not Individually Identifiable
   01/2006 Frequently Asked Questions About Medical Devices - Information Sheet (PDF - 105KB)
   03/2006 The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical
   Trial Sponsors
   08/2004 Independent Consultants for Biotechnology Clinical Trial Protocols
   04/2007 Adverse Event Reporting - Improving Human Subject Protection
   02/2005 Clinical Lactation Studies - Study Design, Data Analysis, and Recommendations for Labeling
   01/2006 Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products -
   Content and Format
   10/2000 Submitting and Reviewing Complete Responses to Clinical Holds
   12/2006 Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children
   in Clinical Investigations
   07/2006 Exception from Informed Consent Requirements for Emergency Research
   10/2009 Investigator Responsibilities--Protecting the Rights, Safety and Welfare of Study Subjects,
   05/2010 Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and
   Sponsors--Clinical Investigator Administrative Actions--Disqualifications
Combination Products Guidance Documents
   12/2009 Guidance for Industry - New Contrast Imaging Indication Considerations for Devices and
   Approved Drug and Biological Products (PDF - 159KB)
   04/2009 Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and
   Biological Products (PDF - 112KB)
   07/2007 Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products
   (HCT[sol]Ps)
   09/2006 Minimal Manipulation of Structural Tissue (Jurisdictional Update)
   09/2006 Early Development Considerations for Innovative Combination Products
   08/2005 How to Write a Request for Designation (RFD)
   04/2005 Application User Fees for Combination Products
   09/2004 Current Good Manufacturing Practice for Combination Products (Draft Guidance)
   05/2004 Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of
   a Combination Product
Import and Export Guidance Documents
   07/12/2004 FDA Export Certificates
   07/23/2007 Exports Under the FDA Export Reform and Enhancement Act of 1996
   05/01/2001 E 10 Choice of Control Group and Related Issues in Clinical Trials
   01/01/2009 Good Importer Practices (Draft Guidance)

IX. Office of Regulatory Affairs (ORA)

    For information on a specific guidance document or to obtain a 
paper copy, please go to FDA's Web site: http://www.fda.gov/
RegulatoryInformation/Guidances/Default.htm.
    The following is a list of ORA guidance documents that have been 
withdrawn:

------------------------------------------------------------------------
                                                     Date of
           Title of document            --------------------------------
                                            Issuance        Withdrawal
------------------------------------------------------------------------
Compliance Policy Guide Sec. 608.100     March 19, 1991  July 7, 2006
 Human-Labeled Drugs Distributed and
 Used in Animal Medicine (CPG 7125.35)
------------------------------------------------------------------------
Compliance Policy Guide Sec. 616.100     October 1,      July 7, 2006
 Streptomycin Residues in Cattle          1980
 Tissues (CPG 7125.22)
------------------------------------------------------------------------
Compliance Policy Guide Sec. 555.700     February 1,     January 8, 2008
 Revocation of Tolerances for Cancelled   1983
 Pesticides (CPG 7120.29)
------------------------------------------------------------------------
Compliance Policy Guide Sec. 560.700     October 1,      June 6, 2008
 Processing of Imported Frozen Products   1980
 of Multiple Sizes (e.g., Shrimp,
 Prawns, Etc.) (CPG 7119.10)
------------------------------------------------------------------------
Compliance Policy Guide Sec. 540.575     October 1,      July 18, 2008
 Fish--Fresh and Frozen--Adulteration     1980
 Involving Decomposition (CPG 7108.05)
------------------------------------------------------------------------
Compliance Policy Guide Sec. 540.375     October 1,      March 22, 2010
 Canned Salmon--Adulteration Involving    1980
 Decomposition (CPG 7108.10)
------------------------------------------------------------------------

    The following is a list of current ORA guidance documents:

[[Page 48233]]

----------------------------------------------------------------------------------------------------------------
                   Title of Document                                         Date of Issuance
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual                          .......................................................
----------------------------------------------------------------------------------------------------------------
Application Integrity Policy Procedures                  March 5, 1998
                                                         (Edited for format March 4, 2004)
----------------------------------------------------------------------------------------------------------------
Points to Consider for Internal Reviews and Corrective   June 1991
 Action Operating Plans
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff: Reduction of Civil  March 20, 2001 (Effective: April 19, 2001)
 Money Penalties for Small Entities                      (This document supersedes the Draft Civil Money Penalty
                                                          Reduction Policy for Small Entities released on May
                                                          18, and June 15, 1999.)
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Good Laboratory Practice          August 1979
 Regulations Management Briefings Post Conference        (Minor editorial and formatting changes made November
 Report                                                   1998)
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Good Laboratory Practices         June 1981
 Questions and Answers                                   (Minor editorial and formatting changes made December
                                                          1999, September 2000, & July 2007)
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Product Recalls, Including        November 3, 2003
 Removals and Corrections
----------------------------------------------------------------------------------------------------------------

    Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19342 Filed 8-6-10; 8:45 am]
BILLING CODE 4160-01-S