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CLIA Waiver Study Guidelines Simplified By US FDA In Latest Revisions

 
• By Sue Darcey

FDA took the unusual step of issuing a second round of draft guidance documents in its effort to refine requirements for diagnostics companies seeking a CLIA waiver to allow point-of-care use of a test. The revised drafts are simplified compared to November 2017 versions, and they appear to line up more closely with industry arguments about what is needed to demonstrate "accuracy" in this context.

Guidance word in red keyboard buttons

USFDA has returned to the drawing board with some draft advice to in vitro diagnostic device manufacturers on what types of studies are needed to qualify a test for use at the point of care.

Two new draft guidances were postedby the agency Nov. 29, about a year after its first attempt to follow...

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