(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 |
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(3/20/98) |
PMA/510(k) Expedited Review - Guidance for
Industry and CDRH Staff |
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(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 |
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(2/19/98) |
Procedures for Class II Device Exemptions
from Premarket Notification, Guidance for Industry and CDRH Staff |
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(2/19/98) |
New Section 513(f)(2) - Evaluation of Automatic
Class III Designation, Guidance for Industry and CDRH Staff |
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(2/19/98) |
Guidance on PMA Interactive Procedures for
Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry |
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(7/22/2000) |
Guidance on Amended Procedures for Advisory
Panel Meetings |
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(1/20/98) |
Guidance on IDE Policies and Procedures |
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(2/28/01) |
Early Collaboration Meetings Under the FDA
Modernization Act (FDAMA), Final Guidance for Industry and CDRH Staff |
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