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U.S. Department of Health and Human Services

Medical Devices

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CLIA Waiver Decisions Made During FY2009 and FY2010 (MDUFMA FDA Performance Report January 26, 2010)

CLIA Waiver Decisions Made During FY2009

FDA Decision FDA Days MFG Days Total
APPR – Approved 248 38 286
APPR – Approved 248 38 286
APPR – Approved 398 0 398
APPR – Approved 398 0 398
Received in FY09, Not yet complete 179 N/A N/A
Received in FY09, Not yet complete 343 N/A N/A
Received in FY09, Not yet complete 33 N/A N/A

CLIA Waiver Decisions Made During FY2010

FDA Decision FDA Days MFG Days Total
APPR – Approved 77 0 77
APPR – Approved 233 0 233
APPR – Approved 204 64 268
DENIED 320 426 746
Received in FY09, Not yet complete 199 N/A N/A
Received in FY09, Not yet complete 259 N/A N/A
Received in FY09, Not yet complete 411 N/A N/A
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