Advisory Committees
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2011 Meeting Materials of the Microbiology Devices Panel
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June 29, 2011: Microbiology Devices Panel Meeting Materials (FDA Generated)
Agenda (PDF - 49KB)Roster (PDF - 48KB)FDA Panel Questions (PDF - 25KB)- FDA Executive Summary and Questions (PDF - 302KB)
510K Premarket Process (PDF - 92KB)PMA Process (PDF - 74KB)FDA Reclassification Process (PDF - 37KB)Presentation: Burman (PDF - 1.1MB)Presentation: Castro (PDF - 402KB)MMWR for IGRAS Use (PDF - 639KB)MMWR Updated NAA Guidelines (PDF - 409KB)24 meeting summary (PDF - 34KB)Transcript (PDF - 1.1MB)
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June 29, 2011: Microbiology Devices Panel Meeting Materials (Non-FDA Generated)
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