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U.S. Department of Health and Human Services

Medical Devices

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Guidance Pertaining to the FDA Modernization Act of 1997

 Third Party Documents

Guidance and other information on the FDAMA third party (Accredited Persons) program is available at: Third Party Review

(11/2000) Inclusion of Certain Devices Within the Accredited Persons Program - Third Party Review of Clinical Data: A Report to Congress

 IDE/PMA/510(k) Related Documents

(8/9/2000) Guidance for Industry and FDA Reviewers on Section 216 of the Food and Drug Administration Modernization Act of 1997
(11/99) A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress
(11/4/98) Guidance for Industry General/Specific Intended Use
(5/20/98) Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review
(3/20/98) PMA/510(k) Expedited Review - Guidance for Industry and CDRH Staff
(2/19/98) 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH
(1/30/98) Determination of Intended Use for 510(k) Devices - Guidance for Industry and CDRH Staff
(2/19/98) Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff
(2/19/98) New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff
(2/19/98) Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry
(7/22/2000) Guidance on Amended Procedures for Advisory Panel Meetings
(1/20/98) Guidance on IDE Policies and Procedures
(2/28/01) Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Final Guidance for Industry and CDRH Staff

 Postmarket Surveillance / Device Tracking

(10/29/08) PRS and U.S. Public Law 110-85
(4/27/06) Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act
(11/2/98) SMDA to FDAMA: Guidance on FDAs Transition Plan for Existing Postmarket Surveillance Protocols
(1/24/00) Guidance on Medical Device Tracking
(9/99) Designing A Medical Device Surveillance Network: A Report To Congress
  (6/16/99) Related Document: Appendix A: Final Report of a Study To Evaluate the Feasibility and Effectiveness of a Sentinel Reporting System for Adverse Event Reporting of Medical Device Use in User Facilities
 

 Standards

(7/20/01) Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA
(7/99) FDA Recognized Consensus Standards Appendix A
(06/20/2001) Frequently Asked Questions on the Recognition of Consensus Standards; Final Guidance for Industry and for FDA Staff
(9/21/1998) Opportunity to Recommend Standards for CDRH Recognition
(06/20/2001) CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition; Final Guidance for Industry

 Other Documents

(7/2/01) Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA
  (11/18/98) Related Document: Final Rule: Administrative Practices and Procedures; Internal Review of Decisions
(2/98) Medical Device Appeals and Complaints - Guidance on Dispute Resolution
(2/6/98) FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions