| These documents supplement information presented in the audioconference |
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Document Title |
Pages |
Check here to Download |
| 1 |
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review, Feb 2005. (Note - although this is CDER reviewer guidance, the content is equally applicable to medical devices,) |
88 |
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| 2 |
Medical Device Reporting for User Facilities - guidance, April 1996. |
36 |
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| 3 |
Medical Device Reporting: An Overview - Guidance, April 1996 |
25 |
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| 4 |
Medical Device Reporting for Manufacturers - Guidance, March 1997 |
50 |
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| 5 |
Medical Device Tracking - Guidance for Industry and FDA Staff, May 2003 |
20 |
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| 6 |
Establishment and Operation of Clinical Trial Data Monitoring Committees - Guidance, Nov 2001 |
35 |
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| 7 |
Summary of New Electronic Safety Reporting Requirements, 20Aug2009 |
2 |
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| 8 |
21Aug09 Federal Register. Proposed Electronic Safety Reporting Requirements for Drugs, Biologics and Medical Devices. Regulations become effective Aug 21, 2010. |
20 |
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