FDA Posts Draft Guidance on Premarket Submissions for Devices
The Food and Drug Administration posted a new draft guidance on the use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. The draft guidance also proposes two changes in policy,…
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the first being that declarations of conformity would no longer be used when the submitter deviates from an FDA standard, and the second being that promissory statements indicating future compliance with a consensus standard would no longer be used. Comments on the draft guidance are due Aug. 11, said FDA in a concurrent Federal Register notice (here).