Medical Devices

CLIA Waiver Decisions for FY2010 (MDUFMA FDA Performance Report October 27, 2010)

CLIA WAIVER BY APPLICATION WORKLOAD

CLIA Waiver Decisions Made During FY2009

# FDA Decision FDA Days MFG Days Total
1 APPR – Approved 248 38 286
2 APPR – Approved 248 38 286
3 APPR – Approved 398 0 398
4 APPR – Approved 398 0 398
5 DENIED 189 0 189
6 Received in FY09, Not yet complete 33 N/A N/A
7 Received in FY09, Not yet complete 259 N/A N/A

CLIA Waiver Decisions Made During FY2010

# FDA Decision FDA Days MFG Days Total
1 APPR – Approved 77 0 77
2 APPR – Approved 233 0 233
3 APPR – Approved 204 64 268
4 DENIED 320 426 746
5 DENIED 419 0 419
6 DENIED 172 0 172
7 DENIED 285 0 285
8 DENIED 555 7 562
9 Received in FY10, Not yet complete 121 N/A N/A

 

Page Last Updated: 04/02/2015
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