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Notice

Annual Guidance Agenda

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. FDA committed to publishing, on an annual basis, a list of possible topics for future guidance document development or revision during the next year, and seeking public comment on additional ideas for new guidance documents or revisions of existing ones. This commitment was made in FDA's September 2000 good guidance practices (GGPs) final rule, which sets forth the agency's policies and procedures for the development, issuance, and use of guidance documents. This list is intended to seek public comment on possible topics for guidance documents and possible revisions to existing guidances.

DATES:

Submit written or electronic comments on this list and on agency guidance documents at any time.

ADDRESSES:

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments.

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FOR FURTHER INFORMATION CONTACT:

For general information regarding this list contact: Diane Sullivan, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

For information regarding specific topics or guidances: Please see contact persons listed in the table in the SUPPLEMENTARY INFORMATION section.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September 19, 2000 (65 FR 56468), FDA published a final rule announcing its GGPs, which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents. The agency adopted the GGPs to ensure public involvement in the development of guidance documents and to enhance public understanding of the availability, nature, and legal effect of such guidance.

As part of FDA's effort to ensure meaningful interaction with the public regarding guidance documents, the agency committed to publishing an annual guidance document agenda of possible guidance topics or documents for development or revision during the coming year. The agency also committed to soliciting public input regarding these and additional ideas for new topics or revisions to existing guidance documents (65 FR 56468 at 56477, 21 CFR 10.115(f)(5)).

The agency is neither bound by this list of possible topics nor required to issue every guidance document on this list or precluded from issuing guidance documents not on the list set forth in this document.

The following list of guidance topics or documents represents possible new topics or revisions to existing guidance documents that the agency is considering. The agency solicits comments on the topics listed in this document and also seeks additional ideas from the public.

The guidance documents are organized by the issuing center or office within FDA, and are further grouped by topic categories. The agency's contact persons are listed for each specific area in the table.

Title/Topic of GuidanceContact
II. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
CATEGORY—COMPLIANCE AND INSPECTION
Reprocessing, Reworking, and Blending of Biological Drug Substances and Drug ProductsStephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
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Design, Installation and Operation of Heating, Ventilation and Air Conditioning Systems Used in the Manufacture of Products Regulated by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and ResearchSame as above (Do)
Compliance Program 7341.002—Inspection of Tissue EstablishmentsDo
Compliance Program 7342.001—Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and ContractorsDo
Compliance Program 7342.002—Inspection of Source Plasma EstablishmentsDo
Compliance Program 7342.008—Inspections of Licensed Viral Marker Test KitsDo
Compliance Program 7345.001—Inspection of Center for Biologics Evaluation and Research-Regulated Biological Drug ProductsDo
CATEGORY—CELLULAR, TISSUE, AND GENE THERAPY
Submission of Information for the National Xenotransplantation DatabaseDo
Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Controls Reviewers of Human Gene Therapy Investigational New Drug ApplicationsDo
Submission of Information for Adverse Event and Annual Reports for Gene Therapy Investigational New Drug ApplicationsDo
Eligibility Determination for Donors of Human Cells, Tissue and Cellular and Tissue-Based ProductsDo
CATEGORY—BLOOD AND BLOOD COMPONENTS
Blood Establishment SoftwareDo
Collection of Platelets, Pheresis Prepared by Automated MethodsDo
Validation of the Computer CrossmatchDo
Blood Contact MaterialsDo
Nucleic Acid Testing for Human Immunodeficiency Virus and Hepatitis C Virus; Testing, Product Disposition, Donor Deferral and Re-entryDo
Efficacy, Pharmokinetic, and Safety Studies to Support Marketing of Immune Globulin Intravenous (Human) as a Replacement Therapy for Primary Humoral ImmunodeficiencyDo
Guidance on the Content of Premarket Submissions for Center for Biologics Evaluation and Research-Regulated Automated Instruments and Associated Software Systems for Donor Blood Collection and ScreeningDo
CATEGORY—VACCINES
Characterization and Qualification of Cell Substances and Viral Seeds Used to Produce Viral VaccinesDo
Preclinical Toxicity Studies for Prophylactic VaccinesDo
Immunization Human Plasma Donors to Obtain Source Plasma for Preparation of Specific Immune GlobulinsDo
Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related ProductDo
Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch TestDo
CATEGORY—OTHER
Providing Regulatory Submission in Electronic Format—StabilityDo
Environmental Assessment/National Environmental Policy ActDo
Filing and Application When the Applicant Protests a Refusal to File ActionDo
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Multi-Product Manufacturing With Spore-Forming MicroorganismsDo
Good Review Practices—Track IVDo
Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived ProductsDo
Submission of Chemistry, Manufacturing, and Control Information for a Therapeutic Recombinant Deoxyribonucleic Acid-Derived Product or a Monoclonal Antibody for In-Vivo UseDo
III. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff and Third PartiesJohn F. Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and Third PartiesDo
Mutual Recognition Agreement Between the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; DraftChristine Nelson, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806
Regulation of Medical Devices; Background Information for International Officials (Entire Document Available on Disk)Ron Parr, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806
Guidance for Staff, Industry, and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European CommunityJohn F. Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806
Medical Device Appeals and Complaints: A Guidance on Dispute ResolutionDo
Overview of Food and Drug Administration Modernization Act of 1997 Medical Device Provisions (Food and Drug Administration Modernization Act)Do
Medical Device Reporting for ManufacturersDo
In Vitro Diagnostic Devices: Guidance for the Preparation of Premarket Notification Submissions (FDA 97-4224)Do
Medical Device Quality Systems Manual: A Small Entity Compliance GuideDo
Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (Include 126)Do
Premarket Notification: 510(k)—Regulatory Requirements for Medical Devices (FDA 95-4158)Do
Labeling—Regulatory Requirements for Medical Devices (FDA 89-4203)Paula G. Silberberg, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217
Impact Resistant Lenses: Questions and Answers (FDA 87-4002)Do
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use (Draft)Lily Ng, Center for Devices and Radiological Health (HFZ-510), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-0885
Frequently Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional QuestionsDo
Frequently Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA StaffPaula G. Silberberg, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217
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Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA ReviewersDo
Center for Devices and Radiological Health Manual for the Good Guidance Practices Regulations; Final Guidance for FDA StaffRon D. Kaye, Center for Devices and Radiological Health (HFZ-205), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3265
Medical Device Use—Safety: Incorporating Human Factors Engineering Into Risk Management; Guidance for Industry and FDA Premarket and Design Control ReviewersCenter for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217
Human Factors Points to Consider for Investigational Device Exemption DevicesAlvin W. Thomas, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-2436
Do It By Design—An Introduction to Human Factors in Medical DevicesWalter l. Scott, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3266
Medical Device Reporting for User FacilitiesMargaret T. Tolbert, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-2436
Human Factors Principles for Medical Device LabelingCenter for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217
Write It RightCharles A. Finder, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3332
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #8 (Incorporated into Policy Guidance Help Systems)Do
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #5; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
Compliance Guidance—The Mammography Quality Standards Act Final Regulations—Preparing for Mammography Quality Standards Act Inspections (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #3; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System Due to the September 11, 2001, Terrorist Attacks; Final Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
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The Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
Compliance Guidance—Mammography Facility Survey, Equipment Evaluation and Medical Physicist Qualification Requirements Under MQSA; Final (Incorporated into Policy Guidance Help System)Do
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3 (Incorporated into Policy Guidance Help System)Do
The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System #1; Guidance for Industry and FDA (Incorporated into Policy Guidance Help System)Do
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2 (Incorporated into Policy Guidance Help System)Do
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Quality Assurance Documentation (Incorporated into Policy Guidance Help System)Do
Guidance for Request and Issuance of Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) (Incorporated into Policy Guidance Help System)Do
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (Incorporated into Policy Guidance Help System)Do
Guidance: The Mammography Quality Standards Act Final Regulations Document #1 (Incorporated into Policy Guidance Help System)Do
Guidance for Industry—Requalification for Interpreting Physician's Continuing Experience Requirement (Incorporated into Policy Guidance Help System)Do
Policy and Standard Operating Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies (Incorporated into Policy Guidance Help System)Do
Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act (42 U.S.C. 263(b)) (April 8, 1998) (Incorporated into Policy Guidance Help System)Paula G. Silberberg, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1217
Guidance for Submission of Request for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts (42 U.S.C. 263(b)) (April 8, 1998) (Incorporated into Policy Guidance Help System)Do
Continuing Education Credit for Reading/Writing Articles/Papers and Presenting Courses/Lectures (Incorporated into the Policy Guidance Help System)Do
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations to State and Local AgenciesThomas E. Cardamone, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-0806, ext. 117
Office of Device Evaluation
Fiscal Year 2004 MDUFMA Small Business Qualification Worksheet and Certification—Guidance for Industry and FDAJoanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Premarket Assessment of Pediatric Medical Devices—Draft Guidance for Industry and FDA StaffHeather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Pediatric Expertise for Advisory Panels—Guidance for Industry and FDA StaffJoanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
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Premarket Approval Application Filing Review—Guidance for Industry and FDA StaffCenter for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Guidance for Industry and FDA: Fiscal Year 2003 MDUFMA Small Business Qualification Worksheet and CertificationDo
Assessing User Fees: Premarket Approval Application Supplement Definitions, Modular Premarket Approval Application Fees, Biologics License Application and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination ProductsDo
Determination of Intended Use for 510(k) Devices; Guidance for Center for Devices and Radiological Health StaffDo
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and IndustryThninh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDARobert R. Gatling, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Availability of Information Given to Advisory Committee Members in Connection With Center for Devices and Radiological Health Open Public Panel Meetings; Draft Guidance for Industry and FDA StaffNancy J. Pluhowski, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022
Humanitarian Device Exemptions Regulation: Questions and Answers; Final Guidance for IndustryHeather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and Center for Devices and Radiological Health StaffDonna-Bea Tillman, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022
Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry and for Center for Devices and Radiological Health StaffDo
Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and IndustryKaren F. Warbuton, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1744
Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997Nicole Wolanski, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186
Guidance on Amended Procedures for Advisory Panel Meetings; FinalDaniel G. Schultz, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022
Guidance on the Use of Standards in Substantial Equivalence Determinations; FinalHeather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Guidance for Off-the-Shelf Software Use in Medical Devices; FinalJoanna H. Weitershausen, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8611
Medical Devices Containing Materials Derived From Animal Sources (Except In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; FinalNicole Wolanski, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186
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Premarket Approval Application Modular ReviewPhilip J. Phillips, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2022
Guidance for Industry; General/Specific Intended Use; FinalThninh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186
Frequently Asked Questions on the New 510(k) Paradigm; FinalDo
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; FinalDo
Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; FinalDo
A New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket NotificationsDo
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for DevicesJoanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
PMA/510(k) Expedited Review G94-4 (blue book memo)Thninh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186
30-Day Notices and 135-Day Premarket Approval Application Supplements for Manufacturing Method or Process Changes, Guidance for Industry and Center for Devices and Radiological Health (Docket 98D-0080); FinalHeather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Guidance on Premarket Approval Application Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—for Use by Center for Devices and Radiological Health and Industry; FinalThninh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186
New Section 513(f)(2)—Evaluation of Automatic Class III Designation: Guidance for Industry and Center for Devices and Radiological Health Staff; FinalDo
Procedures for Class II Device Exemptions From Premarket Notification Guidance for Industry and Center for Devices and Radiological Health Staff; FinalDo
Guidance on Investigational Device Exemption Policies and Procedures; FinalHeather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data PackagesDo
Kit Certification for Premarket NotificationsDo
Convenience Kits Interim Regulatory GuidanceDo
Real-Time Review Program for Premarket Approval Application SupplementsDo
Deciding When to Submit a Premarket Notification for a Change to an Existing Device (K97-1)Do
Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care FacilitiesDo
Memorandum of Understanding Regarding Patient Labeling Review (blue book memo #G96-3)Do
Continued Access to Investigational Devices During Premarket Approval Application Preparation and Review (blue book memo) (D96-1)Do
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Format for Investigational Device Exemption Progress ReportsDo
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer GuidanceDo
Premarket Notification Quality Review Program (blue book memo)Do
Suggested Content for Original Investigational Device Exemption Application Cover LetterDo
Indications for Use StatementDo
Cover Letter: Premarket Notification Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (blue book memo #K95-1)Do
#D95-2, Attachment A (Interagency Agreement Between FDA & Health Care Financing AdministrationDo
#D95-2, Attachment B (Criteria for Categorization of Investigational Devices Health Care Financing AdministrationDo
Health Care Financing Administration Reimbursement Categorization Determinations for FDA-Approved Investigational Device ExemptionsDo
Implementation of the FDA/Health Care Financing Administration Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Attachment A Interagency Agreement, Attachment B Criteria for Categorization of Investigational Devices, and Attachment C -List #D95-2 (blue book memo)Do
Goals and Initiatives for the Investigational Device Exemption Program #D95-1 (blue book memo)Joanne R. Less, Center for Devices and Radiological Health (HFZ-403), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and SolutionsHeather S. Rosecrans, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1190
Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing7rsquo; (Replaces #G87-1 #8294) (blue book memo)Do
Premarket Approval Application Closure #P94-2 (blue book memo)Do
Premarket Notification Sign-Off Procedures #K94-2 (blue book memo)Do
Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer From Susan AlpertDo
Premarket Notification Refuse to Accept Procedures #K94-1 (blue book memo)Do
Investigational Device Exemption Refuse to Accept Procedures #D94-1 (blue book memo)Do
Preamendments Class III Strategy Premarket Notification Status Request FormDo
Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo)Do
Premarket Notification Additional Information Procedures #K93-1 (blue book memo)Do
Center for Devices and Radiological Health's Investigational Device Exemption Refuse to Accept PolicyDo
Center for Devices and Radiological Health's Premarket Notification Refuse to Accept Policy—(Updated Checklist for March 14, 1995)Do
Classified Convenience KitsDo
Telephone Communications Between Office of Device Evaluation Staff and Manufacturers #I93-1 (blue book memo)Do
Preamendment Class III DevicesDo
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Nondisclosure of Financially Sensitive Information #I92-1 (blue book memo)Do
Document Review Processing #I91-1 (blue book memo)Do
Integrity of Data and Information Submitted to Office of Device Evaluation #I91-2 (blue book memo)Do
Panel Review of Premarket Approval Applications #P91-2 (blue book memo)Do
Premarket Approval Application Compliance Program #P91-3 (blue book memo)Do
Shelf Life of Medical DevicesDo
Device Labeling Guidance #G91-1 (blue book memo)Do
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (blue book memo)Do
Consolidated Review of Submissions for Lasers and Accessories #G90-1 (blue book memo)Do
Assignment of Review Documents #I90-2 (blue book memo)Do
Policy Development and Review Procedures #I90-1 (blue book memo)Do
Substantial Equivalence Decision Making Documentation ATTACHED: ‘SE’ Decision Making Process (Detailed) (i.e., the decision making tree)Do
Threshold Assessment of the Impact of Requirements for Submission of Premarket Approval Applications for 31 Medical Devices Marketed Prior to May 28, 1976Do
Meetings With the Regulated Industry #I89-3 (blue book memo)Do
Toxicology Risk Assessment Committee #G89-1 (blue book memo)Do
Review of IDEs for Feasibility Studies #D89-1 (blue book memo)Do
Premarket Notification—Consistency of Reviews #K89-1 (blue book memo)Do
Review of Laser Submissions #G88-1 (blue book memo)Do
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin TestDo
Limulus Amebocute Lysate; Reduction of Samples for TestingM. Sussan Runer, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283
Master Files Part III; Guidance on Scientific and Technical InformationDo
Guideline on General Principles of Process ValidationDo
Industry Representatives on Scientific PanelDo
Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (blue book memo)Do
Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo)Do
Points to Consider in the Characterization of Cell Lines Used to Produce Biological ProductsDo
Application of the Device Good Manufacturing Practice Regulation to the Manufacture of Sterile DevicesDo
Methods for Conducting Recall Effectiveness ChecksDo
Guidance for Submitting Reclassification PetitionDo
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval ApplicationsDo
Bundling Multiple Devices or Multiple Indications in a Single Submission—Guidance for Industry and FDA StaffDo
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FDA and Industry Actions on Premarket Approval Applications: Effect on FDA Review Clock and Performance AssessmentDo
Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; DraftDo
Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2 and Oxygen (PcO2) Monitors; Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDADo
Heated Humidifier Review GuidanceDo
Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing of Dental Restorations; Guidance for Industry and FDAAnthony Watson, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-824-1287
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Guidance for Industry and FDA ReviewersDo
Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDADo
Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; FinalDo
Guidance for the Preparation of Premarket Notifications for Dental CompositesDo
Dental Cements—Premarket Notification; FinalDo
Dental Impression Materials—Premarket Notification; FinalDo
Over-the-Counter Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; FinalDo
Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous ImplantsKevin Mulry, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283
Guidance Document on Dental HandpiecesDo
Guidance for the Arrangement and Content of a Premarket Approval Application for an Endosseous Implant for Prosthetic AttachmentDo
Premarket Notification Submissions for Chemical Indicators; Guidance for Industry and FDA StaffDo
Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal AlloysDo
Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Base Metal AlloysDo
Supplementary Guidance on Premarket Notifications for Medical Devices With Sharps Injury Prevention Features; Guidance for Industry and FDADo
Guidance on Premarket Notifications for Intravascular Administration SetsDo
Neonatal and Neonatal Transport Incubators—Premarket Notifications; FinalDo
Guidance on the Content of Premarket Notification Submissions for Protective RestraintsDo
Guidance on Premarket Notification Submissions for Short-Term and Long-Term Intravascular CathetersDo
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Guidance on the Content of Premarket Notification Submissions for Hypodermic Single Lumen NeedlesDo
Guidance on the Content of Premarket Notification Submissions for Piston SyringesDo
Guidance on the Content of Premarket Notification Submissions for Clinical Electronic ThermometersDo
Guidance on the Content of Premarket Notification Submissions for External Infusion PumpsDo
Guidance on Premarket Notification Submissions for Implanted Infusion PortsDo
Surgical Masks—Premarket Notification Submissions; Draft GuidanceBram D. Zuckerman, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8320
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDADo
Premarket Notification Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDADo
Premarket Notifications for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA ReviewersElias Mallis, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517
Premarket Approval Applications for Sharps Needle Destruction Devices; Final Guidance for Industry and FDADo
Guidance on the Content and Format of Premarket Notification Submissions for Liquid Chemical Sterilants and High Level Disinfectants; FinalDo
Premarket Notification Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; FinalDo
Center for Devices and Radiological Health Regulatory Guidance for Washers and Washer-Disinfectors Intended for Use in Processing Reusable Medical DevicesDo
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944)Do
Addendum to: Guidance on Premarket Notification Submissions for Sterilizers Intended for Use in Health Care FacilitiesDina Fleisher, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517
Guidance on the Content and Format of Premarket Notification Submissions for Sharps ContainersDo
Guidance on Premarket Notification Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care FacilitiesDo
Guidance on Premarket Notification Submissions for Surgical Gowns and Surgical DrapesDo
Guidance on Premarket Notification for Sterilizers Intended for Use in Health Care FacilitiesAshley Boam, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8243
Battery GuidanceMegan Moynaham, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8517
Policy for Expiration Dating (DCRND RB92-G)Do
Balloon Valvuloplasty Guidance for the Submission of an Investigational Device Exemption Application and a Premarket Approval ApplicationA. Doyle Gantt, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8262
Start Printed Page 41521
Class II Special Controls Guidance Document: Arrhythmia Detector and AlarmDo
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for IndustryDo
Investigational Device Exemption Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA ReviewersDo
Recommended Clinical Study Design for Ventricular Tachycardia AblationNeil R. Ogden, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1307
Nonautomated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; FinalDo
Noninvasive Blood Pressure Monitor GuidanceDo
Electrocardiograph ElectrodeDo
Electrocardiograph Lead Switching AdapterDo
Electrocardiograph Surface Electrode TesterDo
Clinical Study Designs for Percutanwous Catheter Ablation for Treatment of Atrial Fibrillation—Guidance for Industry and FDA StaffDo
Guidance for Annuloplasty Rings Premarket Notification Submissions; Final Guidance for Industry and FDA StaffBarbara Zimmerman, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2036
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter Premarket Notification Submissions; Final Guidance for Industry and FDADo
Guidance for Extracorporeal Blood Circuit Defoamer Premarket Notification Submissions; Final Guidance for Industry and FDADo
Guidance for Cardiopulmonary Bypass Oxygenators Premarket Notification Submissions; Final Guidance for Industry and FDA StaffDo
Guidance for the Preparation of the Annual Report to the Premarket Approval Application Approved Heart Valve ProsthesesDo
Coronary and Cerebrovascular Guidewire GuidanceDo
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor Premarket Notification SubmissionsDo
Implantable Pacemaker Testing GuidanceDo
Guidance Document for Vascular Prostheses Premarket Notification SubmissionsDo
Guidance for Cardiovascular Intravascular Filter Premarket Notification Submissions; FinalDo
Carotid Stent—Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption ApplicationsDo
Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices—Draft Guidance for Industry and FDA StaffDo
Guidance Document for Powered Suction Pump Premarket NotificationsSteven Rhodes, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090
Guidance Document for Surgical Lamp Premarket Notification; FinalDo
Guidelines for Reviewing Premarket Notifications That Claim Substantial Equivalence to Evoked Response StimulatorsDo
Guidance Document for the Preparation of Premarket Notification Applications for Electromyograph Needle ElectrodesDo
Start Printed Page 41522
Guidance on the Content and Organization of a Premarket Notification for a Medical LaserDo
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy DevicesDo
Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Polymethylmethacrylate Bone Cement; Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented ProsthesisTheodore R. Stevens, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1296
Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented Prosthesis Guidance for Spinal System Premarket NotificationsDo
Guidance Document for the Preparation of Investigational Device Exemptions for Spinal SystemsDo
ORDB Premarket Notification Sterility Review GuidanceDo
Reviewers Guidance Checklist for Intramedullary RodsDo
Reviewers Guidance Checklist for Orthopedic External Fixation DevicesDo
Premarket Notification Information Needed for Hydroxyapatite Coated Orthopedic ImplantsDo
Guidance Document for Testing Biodegradable Polymer Implant DevicesDo
Guidance Document for Testing Bone Anchor DevicesDo
Guidance Document for Testing Non-Articulating, ‘Mechanically Locked’, Modular Implant ComponentsDo
Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip SystemsDo
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone CementDo
Guidance Document for the Preparation of Investigational Device Exemption and Premarket Approval Applications for Intra-Articular Prosthetic Knee Ligament DevicesDo
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDAEvertte T. Bears, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2018
Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDADo
Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for IndustryDo
Guidance Document for Dura Substitute Devices; Final Guidance for IndustryDo
Guidance for Neurological Embolization DevicesDo
Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; FinalDo
Guidance for Dermabrasion Devices; FinalDo
Start Printed Page 41523
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; FinalDo
Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; FinalEric A, Mann, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2080
Guidance for Testing Magnetic Resonance Interaction With Aneurysm ClipsDo
Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDADo
Cyanoacrylate Tissue Adhesive for the Topical Approzimation of Ski—Premarket Approval Applications—Guidance for Industry and FDA StaffDo
Saline, Silicone Gel, and Alternative Breast Implants—Draft Guidance for IndustryKesia Alexander, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053
Guidance Document for Powered Muscle Stimulator Premarket Notifications; Final
Guidance Document for the Preparation of Premarket Notification Applications for Therapeutic Massagers and VibratorsDo
Guidance Document for the Preparation of Premarket Notification Applications for BedsDo
Guidance Document for the Preparation of Premarket Notification Applications for Communications Systems (Powered and Nonpowered) and Powered Environmental Control SystemsDo
Guidance Document for the Preparation of Premarket Notification Applications for Exercise EquipmentDo
Guidance Document for the Preparation of Premarket Notification Applications for Heating and Cooling DevicesDo
Guidance Document for the Preparation of Premarket Notification Applications for Immersion HydrobathsDo
Guidance Document for the Preparation of Premarket Notification Applications for Powered Tables and Multifunctional Physical Therapy TablesCarolyn Y. Neuland, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1220
Guidance Document for the Preparation of Premarket Notification Applications for Submerged (Underwater) Exercise EquipmentDo
Guidance Document for the Preparation of Premarket Notification Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesDo
Guidance for Studies for Pain Therapy Devices—General Consideration in the Design of Clinical Studies for Pain-Alleviating DevicesDo
Guidance Document for Nonprescription Sunglasses; Final Ophthalmoscope GuidanceDo
Retinoscope Guidance; FinalDo
Slit Lamp Guidance; FinalDo
Third Party Review Guidance for Phacofragmentation System Device Premarket NotificationDo
Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket NotificationCollin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180
Checklist of Information Usually Submitted in an Investigational Device Exemptions Application for Refractive Surgery Lasers (Excimer)Do
Implantable Middle Ear Hearing Device; Guidance for Industry and FDADo
Start Printed Page 41524
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; FinalDo
Tympanostomy Tubes, Submission Guidance for a Premarket Notification; FinalDo
Guidance For The Arrangement and Content of a Premarket Approval Application For A Cochlear Implant in Children Ages 2 to 17 YearsDo
Guideline for the Arragement and Content of a Premarket Approval Application for a Cochlear Implant in Adults at Least 18 Years of AgeDo
Guideline for the Arrangement and Content of a Premarket Approval Application for a Cochlear Implant in Adults at Least 18 Years of AgeDo
Guidance on Submissions for Keratoprostheses; FinalDo
Aqueous Shunts—Premarket Notification Submissions; FinalDo
FDA Guidelines for Multifocal Intraocular Lens Investigational Device Exemptions Studies and Premarket Approval ApplicationsDo
Important Information About Rophae Intraocular LensesDo
Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; FinalDo
Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; FinalDo
Premarket Notification Guidance for Contact Lens Care ProductsDo
Premarket Notification Guidance Document for Class II Daily Wear Contact LensesDo
New FDA Recommendations and Results of Contact Lens Study (7-Day Letter)Do
Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDADo
Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA ReviewersJanine M. Morris, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194
Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA ReviewersDo
Guidance for Industry and the Center for Devices and Radiological Health Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; FinalDo
Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; FinalDo
Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; FinalDo
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for HemodialysisDo
Class II Special Controls Guidance Document: Breast Lesion Documentation System—Guidance for Industry and FDA StaffDo
Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA ReviewersDo
Class II Special Controls Guidance Document for Clitoral Engorgement DevicesDo
Latex Condoms for Men—Information for Premarket Notifications: Use of Consensus Standards for Abbreviated SubmissionsDo
Uniform Contraceptive Labeling; FinalDo
Letter to Manufacturers of Prescription Home Monitors for Non-Stress TestsDo
Start Printed Page 41525
Letter to Manufacturers of FalloposcopesDo
Thermal Endometrial Ablation Devices (Submission Guidance for an Investigational Device Exemption)Do
Hysteroscopes and Gynecology Laparoscopes—Submission Guidance for a Premarket NotificationDo
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDADo
Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy SourcesDo
Guidance for the Submission of Premarket Notifications for Medical Image Management DevicesDo
Guidance for the Submission of Premarket Notification for Solid State X-Ray Imaging Devices; FinalDo
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories and Nuclear Tomography Systems; FinalDo
Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; FinalDo
Harmonic Imaging With/Without Contrast—Premarket Notification; FinalDo
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; FinalDo
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and TransducersDo
Letter: Notice to Manufacturers of Bone Mineral DensitometersDo
Simplified Premarket Notification Procedures for Certain Radiology Devices: December 21, 1993, Letter From L Yin, Office of Device Evaluation, Division of Reproduction, Abdominal, and Radiological Devices, to National Electrical Manufacturers AssociationAvis T. Danishefsky, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1243
Reviewer Guidance for Automatic X-Ray Film Processor Premarket NotificationDo
Guidance for the Content of Premarket Notifications for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral CalculiDo
Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; FinalDo
Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; FinalDo
Center for Devices and Radiological Health Interim Regulatory Policy for External Penile Rigidity DevicesDo
Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and UrologyDo
Premarket Notification Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical InstrumentsDo
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley CathetersDo
Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry SystemsDo
Guidance for the Content of Premarket Notifications for Urine Drainage BagsDo
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and UrologyDo
Guidance for the Content of Premarket Notifications for Ureteral StentsDo
Perspectives on Clinical Studies for Medical Device Submissions (Statistical)Do
Start Printed Page 41526
Premarket Approval Application Review Statistical ChecklistDo
Statistical Guidance for Clinical Trials of Nondiagnostic Medical DevicesDo
Medical Device Reporting Guidance Document: Remedial Action Exemption; FinalDo
Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single UseDo
Medical Device Reporting Guidance Document No. 1—Intraocular lenses—E1996004; FinalDo
Common Problems: Baseline Reports and Medwatch Form 3500ADo
Medical Device Reporting: An Overview; FinalDo
Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A (MEDWATCH) (Medical Device Reporting); FinalDo
MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting (Medical Device Reporting); FinalDo
Variance from Manufacturer Report Number Format (Medical Device Reporting Letter); FinalDo
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report (Medical Device Reporting); FinalDo
Medical Device Reporting—Alternative Summary Reporting Program; Guidance for IndustryDo
Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (Medical Device Reporting); FinalDo
Needlesticks—Medical Device Reporting GuidanceDo
Guidance on Criteria and Approaches for Postmarket SurveillanceDo
Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (Food and Drug Administration Modernization Act); FinalDo
Guidance on Procedures for Review of Postmarket Surveillance Submissions (Food and Drug Administration Modernization Act); FinalDo
Guidance for Industry and FDA Staff—Safe Medical Devices Act to Food and Drug Administration Modernization Act: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols (Food and Drug Administration Modernization Act); FinalDo
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of PostmarketDo
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for IndustryDo
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket SubmissionsDo
Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated AnalyzersDo
Determination of Intended Use for Premarket Notification Devices; Guidance for the Center for Devices and Radiological Health StaffDo
Guidance for Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 CategorizationDo
Guidance for Clinical Laboratory Improvement Amendments of 1988 Criteria for Waiver; Draft Guidance for Industry and FDADo
Guidance for Industry—Abbreviated Premarket Notification Submissions for In Vitro Diagnostic Calibrators; FinalDo
Start Printed Page 41527
Letter to In-Vitro Device Manufacturers on Streamlined Premarket Approval Applications; FinalDo
Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for Premarket Notification ClearanceDo
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March 14, 1996Do
Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; DraftDo
Premarket Approval Application Filing Review—Guidance for Industry and FDA StaffDo
Breath Nitric Oxide Test System—Class II Special Controls Guidance DocumentDo
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA ReviewersDo
Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDADo
Draft Guidance for Prescription Use of Drugs of Abuse Assays Premarket NotificationsDo
Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse TestingDo
Guidance for Premarket Notifications on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home UseDo
Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; FinalDo
Guidance for Industry In Vitro Diagnostic Chloride Test System; FinalDo
Guidance for Industry In Vitro Diagnostic Creatinine Test System; FinalDo
Guidance for Industry In Vitro Diagnostic Glucose Test System; FinalDo
Guidance for Industry In Vitro Diagnostic Potassium Test System; FinalDo
Guidance for Industry In Vitro Diagnostic Sodium Test System; FinalDo
Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; FinalDo
Guidance for Industry-In Vitro Diagnostic C-Reactive Protein Immunological Test SystemDo
Guidance for Over-the-Counter Human Chorionic Gonadotropin Premarket NotificationsDo
Guidance for Over-the-Counter Ovulation Predictor Premarket NotificationsDo
Over the Counter Screening Tests for Drugs of Abuse: Guidance for Premarket NotificationsDo
Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate NurseryDo
Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various MethodologiesDo
Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase MethodologyDo
Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin In Vitro Diagnostic DevicesLaura A. Alonge, Center for Devices and Radiological Health (HFZ-510), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-0648
Premarket Notification Submissions for Coagulation Instruments—Guidance for Industry and FDA StaffDo
Class II Special Control Guidance Document for Anti-Saccharomyces Cerevisia (S. cerevisiae) Antibody Premarket NotificationsDo
Start Printed Page 41528
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDADo
Document for Special Controls for Erythropoietin Assay Premarket Notifications; FinalDo
Draft Guidance Document for Premarket Notification Submission of Fecal Occult Blood TestsDo
Draft Guidance Document for Premarket Notification Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for In Vitro Diagnostic DevicesDo
Draft Guidance Document for Premarket Notification Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In-Vitro DevicesDo
Draft Guidance for Premarket Notification Submission of Lymphocyte Immunophenotyping In Vitro Diagnostic Devices Using Monoclonal AntibodiesDo
Draft Guidance for Premarketing Approval Review Criteria for Premarket Approval of Estrogen or Progesterone Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding With Dextran-Coated Charcoal Separation, Histochemical Receptor BindDo
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification to FDADo
Guidance for Submission of Immunohistochemistry Applications to FDA; FinalDo
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; FinalDo
Multiplex Tests for Heritable Deoxyribonucleic Acid Markers, Mutations and Expression Patterns; Draft Guidance for Industry and FDA ReviewersDo
Points to Consider for Cervical Cytology DevicesDo
Points to Consider for Hematology Quality Control MaterialsDo
Radioallergosorbent Test Methods for Allergen-Specific Immunoglobulin E (IgE) Premarket Notifications; Final Guidance for Industry and FDADo
Review Criteria for Assessment of Alpha-Fetoprotein In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test MethodologiesDo
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semiautomated Chromosome AnalyzersDo
Review Criteria for Assessment of Rheumatoid Factor In Vitro Diagnostic Devices Using Engzyme-Linked Immunoassay, Enzyme Linked Immunosorbent Assay, Particle Agglutination Tests, and Laser and Rate NephelometryCasper E. Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-4692
Review Criteria for Blood Culture SystemsDo
Review Criteria for In Vitro Diagnostic Devices for Detection of Immunoglobulin Class M Antibodies to Viral AgentsDo
Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay, Indirect Hemagglutination Assay, Radioimmunoasay, and Enzyme Linked Immunosorbent AssayDo
Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)Do
Review Criteria for the Assessment of Anti-Nuclear Antibodies In-Vitro Diagnostic Devices Using Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDADo
Draft Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious MicroorganismsDo
Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C VirusesDo
Start Printed Page 41529
Assays Intended for Diagnosis, Prognosis, or Monitoring of Hepatitis C Virus Infection, Hepatitis C, or Other Hepatitis C-Associated Disease; Draft Guidance for Industry FDADo
Review Criteria for Assessment of Antimicrobial Susceptibility Test DiscsDo
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical SpecimensDo
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium spp. (Tuberculosis)Do
Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter PyloriDo
Review Criteria for Devices Assisting in the Diagnosis of Clostriduim Difficile Associated DiseasesDo
Review Criteria for Devices Intended for the Detection of Hepatitis B ‘e’ Antigen and Antibody to Hepatitis B ‘e’Do
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19Do
Office of Surveillance and Biometrics
Perspectives on Clinical Studies for Medical Device Submissions (Statistical)Do
Premarket Approval Application Review Statistical ChecklistDo
Statistical Aspects of Submissions to FDA: A Medical Device Perspective (Also Includes as Appendix the Article “Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions”)Do
Statistical Guidance for Clinical Trials of Nondiagnostic Medical DevicesDo
Statistical Guidance on Reporting Results From Studies Evaluating Diagnostic Tests; DraftDo
Medical Device Reporting Guidance Document: Remedial Action Exemption; FinalDo
Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single UseDo
Medical Device Reporting Guidance Document No. 1—Intraocular Lenses—E1996004; FinalDo
Common Problems: Baseline Reports and Medwatch Form 3500ADo
Medical Device Reporting: An Overview; FinalDo
Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A (MEDWATCH) (Medical Device Reporting); FinalDo
MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting; FinalDo
Variance From Manufacturer Report Number Format (Medical Device Reporting Letter); FinalDo
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report (Medical Device Reporting); FinalDo
Medical Device Reporting—Alternative Summary Reporting Program; Guidance for IndustryDo
Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (Medical Device Reporting); FinalDo
Needlesticks—Medical Device Reporting GuidanceDo
Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads)Do
Start Printed Page 41530
Guidance on Criteria and Approaches for Postmarket SurveillanceDo
Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (Food and Drug Administration Modernization Act); FinalDo
Guidance on Procedures for Review of Postmarket Surveillance Submissions (Food and Drug Administration Modernization Act); FinalDo
Guidance for Industry and FDA Staff— Safe Medical Devices Act of 1990 to Food and Drug Administration Modernization Act: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols (Food and Drug Administration Modernization Act); FinalDo
Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; FinalDo
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of PostmarketDo
Office of Compliance
Perspectives on Clinical Studies for Medical Device Submissions (Statistical)Do
Commercial Distribution/Exhibit LetterDo
FDA Guide for Validation of Biological Indicator Incubation TimeDo
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)Do
General Principles of Software Validation; Draft GuidanceDo
Guidance on Medical Device Tracking (Food and Drug Administration Modernization Act); Guidance for Industry and FDA StaffDo
Compliance Program Guidance Manual: Inspection of Medical Devices; DraftDo
Procedures for Laboratory Compliance Testing of Television Revivers—Part of Television PacketDo
Guidance on Quality System Regulation Information for Various Premarket Submissions; DraftDo
Surveillance and Detention without Physical Examination of Surgeons' and/or Patient Examination Gloves; Guidance for IndustryDo
Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation Requirements in 21 CFR 1020.31 g)Do
Guidance for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major ComponentsDo
Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product ManufacturersDo
Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)Do
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)Do
Compliance Policy Guide 7133.19: Retention of Microwave Oven Test Record/Cover Letter: August 24, 1981, Retention of Records Required by 21 CFR Part 1002Do
Guidance for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting DeviceDo
A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic UseDo
A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammography X-Ray SystemsDo
Start Printed Page 41531
Compliance Program Guidance Manual: Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA StaffDo
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDADo
Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Under 21 CFR 1002.10Do
Abbreviated Report on Radiation Safety for Microwave Products (Other Than Microwave Ovens) (e.g., Microwave Heating, Microwave Diathermy, Rheumatoid Factor Sealers, Induction, Dielectric Heaters, Security Systems)Do
Guide for Preparing Reports on Radiation Safety of Microwave OvensDo
Guide for Filing Annual Reports for X-Ray Components and SystemsDo
Reporting and Compliance Guide for Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and GuidanceDo
Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (Replaces FDA 82-8127)Do
Guide for Preparing Abbreviated Reports of Microwave and Rheumatoid Factor-Emitting Electronic Products Intended for Medical UseHoward W. Cyr, Center for Devices and Radiological Health (HFZ-114), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-796-0297
Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service ManualsDo
Abbreviated Report on Radiation Safety of Non-Medical Ultrasonic ProductsDo
Guide for Preparing Product Reports for Medical Ultrasound ProductsDo
Letter to Manufacturers, Distributors and Importers of Condom ProductsDo
Letter to Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)Do
Letter to Condom Manufacturers and DistributorsDo
Letter to Manufacturers/Repackers Using CottonDo
Guide for Preparing Product Reports for Lasers and Products Containing LasersDo
Compliance Guide for Laser Products (FDA 86-8260)Do
Condoms: Inspection and Sampling at Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska Memo to Field on April 8, 1987)Do
Dental Hand Piece Sterilization (Dear Doctor Letter)Do
Latex Labeling Letter (Johnson)Do
Pesticide Regulation Notice 94-4:Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between the Environmental Protection Agency and the Food and Drug AdministrationDo
Guide for Preparing Product Reports for Lasers and Products Containing Lasers
Letter to Industry, Powered Wheelchair Manufacturers From RM JohnsonDo
Hazards of Volume Ventilators and Heated HumidifiersDo
Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care ProfessionalsDo
Ethylene Oxide; Ethylene Chlorohydrin; and EthyleneGlycol: Proposed Maximum Residue Limits and Maximum Levels of ExposureDo
Letter to: Manufacturers and Users of Lasers for Refractive Surgery (Excimer)Do
Start Printed Page 41532
Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy Surveillance and Detention Without Physical Examination of Condoms; Guidance for Industry; DraftDo
All U.S. Condom Manufacturers, Importers and RepackagersDo
Manufacturers and Initial Distributors of HemodialyzersDo
Laser Light Show Safety—Who's Responsible? (FDA 86-8262)Do
Suggested State Regulations for Control of Radiation—Volume II Nonionizing Radiation—Lasers (FDA Publication No. 83-8220)Do
Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards ExistDo
Guide for Submission of Information on Industrial X-Ray Equipment Required Under 21 CFR 1002.10Do
Guidance for the Submission of Cabinet X-Ray System Reports Under 21 CFR 1020.40Do
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)Do
Computerized Devices/Processes Guidance—Application of the Medical Device Good Manufacturing Practice to Computerized Devices and Manufacturing ProcessesDo
Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only)Do
Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Unter 21 CFR 1002.10 and 1002.12 (FDA 81-8137)Do
Guide for Preparing Annual Reports for Ultrasonic Therapy ProductsDo
Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (Replaces FDA 82-8127)Do
Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor (Replaces FDA 82-8127) Quality Control Guide for Sunlamp Products (FDA 88-8234)Do
Guide for the Submission of Initial Reports on Computed Tomography X-Ray SystemsDo
Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR Part 1002)Do
Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp ProductsDo
Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR Part 1002)Do
Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance StandardDo
Keeping Up With the Microwave Revolution (FDA Publication No. 91-4160)Do
Quality Assurance Guidelines for Hemodialysis DevicesDo
Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven MiswiringDo
Reporting of New Model Numbers to Existing Model FamiliesDo
Import: Radiation-Producing Electronic Products (FDA 89-8008)Do
Unsafe Patient Lead Wires and CablesDo
Application of a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (Form FDA 3147)Do
Letter to Trade Association: Reuse of Single-Use or Disposable Medical DevicesDo
Start Printed Page 41533
Design Control Guidance for Medical Device ManufacturersDo
Keeping Medical Devices Safe From Electromagnetic InterferenceDo
Safety of Electrically Powered Products: Letter to Medical Devices and Electronic Products Manufacturers From Lilliam Gill and Bruce H. Burlington Correction MemoDo
Enforcement Priorities for Single-Use Deices Reprocessed by Third Parties and Hospitals: Guidance for Industry and for FDA StaffDo
Labeling for Electronic Anti-Theft Systems; Guidance for Industry; FinalDo
Wireless Medical Telemetry Risks and Recommendations, Guidance for Industry; FinalDo
Policy on Warning Label Required on Sunlamp ProductsDo
Policy on Lamp Compatibility (Sunlamps)Do
Office of Science and Technology
Perspectives on Clinical Studies for Medical Device Submissions (Statistical)Do
Guidance on Frequently Asked Questions on Recognition of Consensus Standards (Food and Drug Administration Modernization Act)Do
Guidance on the Recognition and Use of Consensus Standards/Appendix A (Food and Drug Administration Modernization Act)Do
Center for Devices and Radiological Health Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for RecognitionDo
Guidance for Industry and FDA Reviewers: Guidance on Immunotoxicity TestingDo
IV. CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
CATEGORY—ADVERTISING
Promotion of Combination Oral Contraceptive ProductsNancy E. Derr, Center for Drug Evaluation and Research (HFD-5), Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852, 301-594-5400
CATEGORY—CHEMISTRY
Documentation for Antibiotics and Other Cellular Metabolites Produced by Microorganisms Modified Using Recombinant DNA TechnologyDo
CATEGORY—CLINICAL/MEDICAL
Acne VulgarisDo
Ankylosing SpondylitisDo
AntifungalDo
Chemoprevention of Sporadic Colorectal AdenomasDo
Clinical Evaluation of Analgesic Drug ProductsDo
Clinical Evaluation of Drugs for Neuropathic PainDo
Clinical Evaluation of Drugs for NeuropathyDo
Clinical Evaluation of Opiate Analgesic Drug ProductsDo
Clinical Trial Design for the Treatment of Allergic ConjunctivitisDo
Clinical Trial Design for the Treatment of Bacterial BlepharitisDo
Clinical Trial Design for the Treatment of Bacterial ConjunctivitisDo
Clinical Trial Design for the Treatment of Choroidal NeovascularizationDo
Clinical Trial Design for the Treatment of Diabetic Macular EdemaDo
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Clinical Trial Design for the Treatment of Diabetic RetinopathyDo
Clinical Trial Design for the Treatment of Dry EyeDo
Clinical Trial Design for the Treatment of Elevated Intraocular PressureDo
Clinical Trail Design for the Treatment of IritisDo
Clinical Trail Design for the Treatment of Macular Edema (Secondary to Inflammation)Do
Clinical Trail Design for the Treatment of Macular Edema (Secondary to a Vascular Event)Do
Clinical Trail Design for the Treatment of Post-Cataract InflammationDo
Clinical Trail Design for the Treatment of Posterior UveitisDo
Clinical Trial Design for the Treatment of Superficial Punctate KeratitisDo
Chemistry, Manufacturing, and Control, Preclinical, and Clinical Development of Decorporation Agents for the Treatment of Internal Radioactive ContaminationDo
Corticosteroid Induced Adrenal SuppressionDo
Development of Drugs for Chronic Obstructive Pulmonary DiseaseDo
Developing Antiviral Drugs for the Treatment of SmallpoxDo
Drug-Coated Cardiovascular StentsDo
Evaluation of New Treatments for Diabetes MellitusDo
GingivitisDo
Intraocular Pressure LoweringDo
Oral MucositisDo
Patient Reported OutcomesDo
PeriodontitisDo
PsoriasisDo
Safety Review of Clinical DataDo
System Lupus ErythematosusDo
Premarketing Risk AssessmentDo
Development and Use of Risk Minimization Action PlansDo
Good Pharmacovigilance Practices and Pharmacoepidemiologic AssessmentDo
Coronary Drug-Eluting StentsDo
Pharmacogenomic Combination ProductsDo
42. Centralized Institutional Review Boards in Multi-Center TrialsDo
CATEGORY—CLINICAL/PHARMACOLOGY
Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for LabelingDo
Immediate Release to Modified Release Dosage FormsDo
In Vitro Drug Metabolism/Drug Interaction—Guidance for ReviewersDo
Pharmacokinetics in Pregnancy—Study Design, Data Analysis, and Impact on Dosing and LabelingDo
CATEGORY—COMPLIANCE
Start Printed Page 41535
Describing How Positron Emission Tomography Drug Products May Comply With New Current Good Manufacturing Practice RequirementsDo
Expiration Dating of Unit-Dose Repackaged DrugsDo
Maintaining Adequate and Accurate Records During Clinical InvestigationsDo
Current Good Manufacturing Practice For Investigational New Drug and Biological Products—Phase I TestingDo
CATEGORY—ELECTRONIC SUBMISSIONS
Standards for Clinical Data SubmissionsDo
CATEGORY—GENERICS
Abbreviated New Drug Applications Suitability PetitionsDo
Bioequivalence Studies with Clinical Endpoints for Vaginal Antifungal Drug ProductsDo
Defining the Term “Listed Drug” With Respect to Amendments and Supplements to Abbreviated New Drug Applications and Section 505(b)(2) ApplicationsDo
Abbreviated New Drug Applications: Pharmaceutical Solid PolymorphismDo
CATEGORY—GOOD REVIEW PRACTICES
General Clinical Review TemplateDo
CATEGORY—INVESTIGATIONAL NEW DRUG APPLICATION
Consumer Product Safety Commission—Tamper Resistant Packaging for Investigational New DrugsDo
End of Phase 2 MeetingsDo
Pediatric Safety and Efficacy Data in Investigational New DrugsDo
Exploratory Investigational New Drugs: Preclinical and Clinical ConsiderationsDo
CATEGORY—LABELING
Content and Format of the Clinical Pharmacology SectionDo
Content and Format of the Dosage and Administration Section of the Prescription Drug LabelingDo
Content and Format of the Warnings and Precautions, Contraindications, and Boxed Warning Sections of Prescription Drug LabelingDo
Drug Names and Dosage FormsDo
Implementing the New Content and Format Requirements for Prescription Drug LabelingDo
Labeling Dietary Supplements for Women Who Are or Could Be PregnantDo
Pregnancy Labeling RevisionsDo
Submitting Proprietary Names for EvaluationDo
CATEGORY—OVER-THE-COUNTER
Actual Use TrialsDo
Labeling Comprehension Studies for Over-the-Counter Drug ProductsDo
Labeling for Over-the-Counter Human Drug ProductsDo
Labeling of Over-the-Counter Skin Protectant ProductsDo
Labeling Over-the-Counter Human Drug Products; Questions and AnswersDo
CATEGORY—PHARMACOLOGY/TOXICOLOGY
Start Printed Page 41536
Drug-Induced Vascular InjuryDo
CATEGORY—PROCEDURAL
Assessment of Abuse Potential of DrugsDo
Development of a Drug and Pharmacogenetic TestDo
Dispute Resolution Involving Pediatric LabelingDo
Exocrine Pancreatic Insufficiency Drug Products—Submitting New Drug ApplicationsDo
How to Comply With the Pediatric Research Equity ActDo
How to Determine if Human Research With a Radioactive Drug Can Be Conducted Under a Radioactive Drug Research CommitteeDo
Process for Contracts and Written Requests Under the Best Pharmaceutical for Children ActDo
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic ActDo
V. Center for Food Safety and Applied Nutrition (CFSAN)
CATEGORY—DIETARY SUPPLEMENTS
Labeling Dietary Supplements for Women Who Are or Could Be PregnantLinda Pellicore, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1448, FAX 301-436-2636, Linda.Pellicore@cfsan.fda.gov
Dietary Supplements: 75-Day Premarket Notifications for New Dietary IngredientsDo
Substantiation Health Claims GuidanceDo
CATEGORY—FOOD ADDITIVE SAFETY
Final Guidance on Electronic Submissions of Food and Color Additive Petitions (Level 1)George Pauli, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740
Presence of Unintended Varieties of Bioengineered Plant Foods in the Food Supply (Level 1)Do
Chloropropanols Compliance Policy Guides GuidanceDo
CATEGORY—CONSTITUENT OPERATIONS
Equivalence Level 1 GuidanceCathy Carneval, Center for Food Safety and Applied Nutrition (HFS-550), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740
CATEGORY—OFFICE OF COMPLIANCE
Prior Notice of Imported Food Products—Questions and AnswersMay Nelson, Center for Food Safety and Applied Nutrition (HFS-22), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740
VI. CENTER FOR VETERINARY MEDICINE (CVM)
CATEGORY—NEW ANIMAL DRUG APPLICATIONS
Administrative New Animal Drug Application Process (#132)Gail Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., rm. 384, Metropark North II, Rockville, MD 20855, 301-827-1796, gschmer1@cvm.fda.gov
Start Printed Page 41537
Waivers of In Vivo Demonstration of Bioequivalence of Certain Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles (#171)Marilyn Martinez, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., rm. 332, Metropark North II, Rockville, MD 20855, 301-827-7577, mmartin1@cvm.fda.gov
CATEGORY—LABELING
Manufacture and Labeling of Raw Meat Diets for Consumption by Dogs, Cats, and Captive Noncompanion Animal Carnivores and Omnivores (#122)William Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 Standish Pl., rm. 413, Metropark North II, Rockville, MD 20855, 301-827-0179, bburkhol@cvm.fda.gov
Content and Format for Labeling of New Animal Drug Products (#134)Douglass Oeller, Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., rm. 324, Metropark North II, Rockville, MD 20855, 301-827-0131, doeller@cvm.fda.gov
CATEGORY—STATUTORY REQUIREMENTS
Dispute Resolution—FDA Modernization Act (#79)Marcia Larkins, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., rm. 165, Metropark North IV, Rockville, MD 20855, 301-827-4535, mlarkins@cvm.fda.gov
Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (#173)David Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., rm. 390, Metropark North II, Rockville, MD 20855, 301-827-6967, dnewkirk@cvm.fda.gov
Chemistry, Manufacturing, and Control Changes to an Approved New Animal Drug Application or Abbreviated New Drug Applications (#83)Dennis Bensley, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., rm. 320, Metropark North II, Rockville, MD 20855, 301-827-6956, dbensley@cvm.fda.gov
CATEGORY—INTERNATIONAL HARMONIZATION
GL-27: Preapproval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals With Respect to Antimicrobial Resistance (#144)William T. Flynn, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7519 Standish Pl., rm. 173, Metropark North IV, Rockville, MD 20855, 301-827-4514, wflynn@cvm.fda.gov
GL-28: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (#141)Thomas Mulligan, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, rm. E375, Metropark North II, 7500 Standish Pl., Rockville, MD 20855, 301-827-6984, tmulliga@cvm.fda.gov
GL-33: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (#149)Do
GL-36: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (#159)Do
GL-37 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (#160)Do
GL-38 Environmental Impact Assessments for Veterinary Medicinal Products—Phase II (#166)Charles Eirkson, Center for Veterinary Medicine (HFV-103), Food and Drug Administration, rm. 137, Metropark North IV, 7500 Standish Pl., Rockville, MD 20855, 301-827-8561, ceirkson@cvm.fda.gov
CATEGORY—TARGET ANIMAL SAFETY AND EFFECTIVENESS
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Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals (#123)Linda Wilmot, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., rm. N316, Metropark North II, Rockville, MD 20855, 301-827-0135, lwilmot@cvm.fda.gov
CATEGORY—HUMAN FOOD SAFETY
Dioxin in Minerals Used in Animal Feed (#161)Gloria Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl., rm. E480, Metropark North II, Rockville, MD 20855, 301-827-1168, gdunnava@cvm.fda.gov
Salmonella Contamination of Feeds Compliance Policy GuideHenry Ekperigin, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., rm. E417, Metropark North II, Rockville, MD 20855, 301-827-0174, hekperig@cvm.fda.gov
Bovine Spongiform Encephalopathies Compliance ProgramNeal Bataller, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl., rm. E441, Metropark North II, Rockville, MD 20855, 301-827-0163, nbatalle@cvm.fda.gov
Validation of Analytical Procedures for Type C Medicated Feed (#135)Mary G. Leadbetter, Center for Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 Standish Pl., rm. E307, Metropark North II, Rockville, MD 20855, 301-827-6964, mleadbet@cvm.fda.gov
VII. OFICE OF REGULATORY AFFAIRS (ORA)
CATEGORY—COMPLIANCE AND INSPECTION
Guidance for Investigators: Investigations Operations ManualMichael Rogers, Division of Field Investigations (HFC-130), Food and Drug Administration, 5600 Fishers Lane, rm. 13-74, Rockville, MD 20857, 301-827-5653
CATEGORY—REGULATORY
Guidance for Food and Drug Administration Staff: Regulatory Information Assurance; Good Practices in Converting From Paper to Electronic ProcessesPaul Motise, Division of Compliance Information and Quality Assurance (HFC-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-827-0383
CATEGORY—COMPLIANCE AND INSPECTIONS
Concept Paper on Bioterrorism Act Proposed Guidance to Records AccessRudaina Alrefai, Division of Compliance Information and Quality Assurance (HFC-240), Food and Drug Administration, 1350 Piccard Dr., rm. 400L, Rockville, MD 20850, 301-827-0413
CATEGORY—GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF
21 CFR Part 58: Good Laboratory Practice, Questions and AnswersJames McCormack, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 400Z, Rockville, MD 20850, 301-827-0425
21 CFR Part 58: Closure of Nonclinical LaboratoriesRodney Allnutt, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 400Y, Rockville, MD 20850, 301-827-8860
21 CFR Part 58: Comparison of the Food and Drug Administration, Environmental Protection Agency, and the Organisation for Economic and Cooperative Development Good Laboratory PracticesJames McCormack, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 400Z, Rockville MD 20850, 301-827-0425.
CATEGORY—GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION INVESTIGATORS
Start Printed Page 41539
Auditing Nonclinical Laboratory StudiesDo
CATEGORY—GUIDANCE FOR FOOD AND DRUG ADMINISTRATION INVESTIGATORS
Necropsy, Tissue Preparation, and Histology in Nonclinical Laboratory StudiesDo
CATEGORY—COMPLIANCE POLICY GUIDE
Section 394.500, Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation during Design Development (CPG 7133.22)Jeffrey Governale, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 410A, Rockville, MD 20850, 301-827-0411
Section 300.500, Reprocessing and Reuse of Single Use Devices (CPG 7124.16)Do
Section 310.210, Blood Pressure Measurement Devices (Sphygmomanometers)—Accuracy (CPG 7124.23)Do
CATEGORY—REGULATORY POLICY MANUAL
Subchapter, Disqualification of Clinical InvestigatorsJames McCormack, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 400Z, Rockville, MD 20850, 301-827-0425
CATEGORY—REGULATORY POLICY MANUAL SUBCHAPTER OR STAFF MANUAL GUIDE
Untrue Statements of Material FactsSharon Sheehan, Division of Compliance Policy (HFC-230), Food and Drug Administration, 1350 Piccard Dr., rm. 450, Rockville, MD 20850, 301-827-0412
CATEGORY—REGULATORY POLICY MANUAL SUBCHAPTER
Application Integrity PolicyDo
CATEGORY—REGULATORY PROCEDURES MANUAL
Chapter 9 ImportsCarl Nielsen, Division of Import Operations (HFC-170), Food and Drug Administration, 5600 Fishers Lane, rm. 12-38, Rockville, MD 20857, 301-443-6553
VIII. OFFICE OF THE COMMISSIONER (OC)
CATEGORY—COMPLIANCE
Guidance for Industry Information Sheets for Institutional Review Boards and Clinical InvestigatorsDavid Lepay, Good Clinical Practice Program (HF-34), Office of Science and Health Coordination, Food and Drug Administration, 5600 Fishers Lane, rm. 9C24, Rockville, MD 20857
Guidance for Industry Computerized Systems Used in Clinical TrialsDo
CATEGORY—INSPECTION
Guidance for FDA Staff Compliance Program 7348.811, Inspection of Clinical Investigators and Sponsor InvestigatorsDo
Start Signature
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Dated: June 30, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 04-15660 Filed 7-8-04; 8:45 am]

BILLING CODE 4160-01-S