Medical Devices

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

 

Page Last Updated: 04/02/2015
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