The FDA Nov. 12 issued a final guidance on molecular diagnostics that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance isn’t required.
Announced in a Nov. 12 Federal Register notice (79 Fed. Reg. 67,175; Docket No. FDA–2013–D–0258), the final guidance, “Molecular Diagnostic Instruments with Combined Functions,” also offers advice on the type of information that should be provided in a premarket submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.
The agency said molecular diagnostic instruments are critical components of certain in vitro diagnostic devices ...
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