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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 and FY2010 (MDUFMA FDA Performance Report January 26, 2010)

CLIA Waiver Decisions Made During FY2009

FDA DecisionFDA DaysMFG DaysTotal
APPR – Approved24838286
APPR – Approved24838286
APPR – Approved3980398
APPR – Approved3980398
Received in FY09, Not yet complete179N/AN/A
Received in FY09, Not yet complete343N/AN/A
Received in FY09, Not yet complete33N/AN/A

CLIA Waiver Decisions Made During FY2010

FDA DecisionFDA DaysMFG DaysTotal
APPR – Approved77077
APPR – Approved2330233
APPR – Approved20464268
DENIED320426746
Received in FY09, Not yet complete199N/AN/A
Received in FY09, Not yet complete259N/AN/A
Received in FY09, Not yet complete411N/AN/A