Medical Devices

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

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

ItemResponsibilityDue dateStatus
leftover specimens guidanceX NoneReg change likely
clinical trial design issues for molecular diagnostic tests guidance XNone?, we haven’t heard anything
migration studies guidanceX NoneX, 1/5/09
herpes simplex virus guidanceX CY 2008X, 4/3/07
enterovirus guidanceX CY 2008X, 1/2/09
influenza testing guidanceX CY 2008X, 2/15/08
pilot CLIA waiver/510(k) concurrent reviewXXNoneX, FY 20082 submitted; lengthened 510(k) and waiver review
CLIA Waiver Protocol Submission XNone?, OIVD / Industry
track CLIA Waiver PerformanceX Annually, & assess at EOY09X, IT issues, tracking manually
class I exempt list X11/1/07X, 9/22/09 submitted by industry, under FDA review
class II exempt list X11/1/07X, 9/22/09 submitted by industry, under FDA review
pre-IDE reviewXXFY 2008X, OIVD & Industry Surveys completed, OIVD drafting guidance


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