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Advisory Committees
2009 Meeting Materials of the Radiological Devices Panel
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November 17, 2009 Meeting Materials-- FDA Generated
- Agenda (PDF - 50KB)
- Panel Questions (PDF - 16KB)
- Public Roster November 17 (PDF - 10KB)
- Attachment 1 FFDM Draft Panel Questions (PDF - 15KB)
- Attachment 2 FFDM Draft Guidance (PDF - 208KB)
- Attachment 3 FFDM PMA Guidance (PDF - 165KB)
- Attachment 4 Summary Minutes (PDF - 59KB)
- Attachment 11 FFDM Panel Transcript (PDF - 595KB)
- FFDM 24 Hour Summary (PDF - 70KB)
- Transcript (PDF - 1018KB)
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November 18, 2009 Meeting Materials-- FDA Generated
- Waiver (DOC - 79KB)
- Acknowledgement (PDF - 18KB)
- CAD Agenda (PDF - 49KB)
- CAD Draft 510K Guidance (PDF - 165KB)
- Draft Clinical Guidance Published (PDF - 141KB)
- Epidemiologic Review Mammography CADe (PDF - 147KB)
- Epidemiologic Review Lung and Colon CADe (PDF - 74KB)
- CADe FDA Discussion Questions (PDF - 29KB)
- CADe 24 Hour Summary (PDF - 69KB)
- Transcript: November 18, 2009 (PDF - 608KB)
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