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U.S. Department of Health and Human Services

Medical Devices

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MDUFA IVD-Specific Goals (MDUFMA FDA Performance Report January 26, 2010)

MDUFA IVD-Specific Goals (as of 1/25/10)

Item Responsibility Due date Status
FDA Industry
leftover specimens guidance X   None Reg change likely
clinical trial design issues for molecular diagnostic tests guidance   X None ?, we haven’t heard anything
migration studies guidance X   None X, 1/5/09
herpes simplex virus guidance X   CY 2008 X, 4/3/07
enterovirus guidance X   CY 2008 X, 1/2/09
influenza testing guidance X   CY 2008 X, 2/15/08
pilot CLIA waiver/510(k) concurrent review X X None X, FY 20082 submitted; lengthened 510(k) and waiver review
CLIA Waiver Protocol Submission   X None ?, OIVD / Industry
track CLIA Waiver Performance X   Annually, & assess at EOY09 X, IT issues, tracking manually
class I exempt list   X 11/1/07 X, 9/22/09 submitted by industry, under FDA review
class II exempt list   X 11/1/07 X, 9/22/09 submitted by industry, under FDA review
pre-IDE review X X FY 2008 X, OIVD & Industry Surveys completed, OIVD drafting guidance