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U.S. Department of Health and Human Services

Medical Devices

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

CLIA WAIVER BY APPLICATION WORKLOAD

CLIA Waiver Decisions Made During FY2009

#FDA DecisionFDA DaysMFG DaysTotal
1APPR – Approved24838286
2APPR – Approved24838286
3APPR – Approved3980398
4APPR – Approved3980398
5DENIED1890189
6Received in FY09, Not yet complete33N/AN/A
7Received in FY09, Not yet complete259N/AN/A

CLIA Waiver Decisions Made During FY2010

#FDA DecisionFDA DaysMFG DaysTotal
1APPR – Approved77077
2APPR – Approved2330233
3APPR – Approved20464268
4DENIED320426746
5DENIED4190419
6DENIED1720172
7DENIED2850285
8DENIED5557562
9Received in FY10, Not yet complete121N/AN/A