Guidance and other information on the FDAMA third party (Accredited Persons) program is available at: http://www.fda.gov/cdrh/thirdparty
| (11/2000) | Inclusion of Certain Devices Within the Accredited Persons Program - Third Party Review of Clinical Data: A Report to Congress |  |
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| (8/9/2000) | Guidance for Industry and FDA Reviewers on Section 216 of the Food and Drug Administration Modernization Act of 1997 |  |
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| (11/99) | A Device Clinical Trials Data Bank - Public Health Need and Impact on Industry; A Report to Congress | |
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| (9/1/99) | Evidence Models for the Least Burdensome Means to Market | |
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| (11/4/98) | Guidance for Industry General/Specific Intended Use | |
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| (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 | |
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| (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 | |
|
| (10/29/08) | PRS and U.S. Public Law 110-85 |
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| (4/27/06) | Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act | |
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| (11/2/98) | SMDA to FDAMA: Guidance on FDAs Transition Plan for Existing Postmarket Surveillance Protocols | |
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| (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 |
|
| (7/20/01) | Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA | |
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| (7/99) | FDA Recognized Consensus Standards Appendix A | |
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| (06/20/2001) | Frequently Asked Questions on the Recognition of Consensus Standards; Final Guidance for Industry and for FDA Staff | |
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| (9/21/1998) | Opportunity to Recommend Standards for CDRH Recognition | |
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| (06/20/2001) | CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition; Final Guidance for Industry | |
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| (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 |  |
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| (11/18/98) Related Document: Final Rule: Administrative Practices and Procedures; Internal Review of Decisions | |
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| (2/98) | Medical Device Appeals and Complaints - Guidance on Dispute Resolution | |
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| (9/21/1998) | Opportunity to Recommend Standards for CDRH Recognition | |
|
| (2/6/98) | FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions | |
|
Updated November 6, 2008
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