FDA Outlines Sweeping 510(k) Reforms Intended To Steer Manufacturers Toward Continual Innovation

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FDA Outlines Sweeping 510(k) Reforms Intended To Steer Manufacturers Toward Continual Innovation

Agency Advocates Sunsetting of Predicates, Use of Objective Criteria To Show Substantial Equivalence

Dennis Tosh

November 28, 2018 at 11:59 AM EST

The FDA Nov. 26 presented an outline of sweeping reforms to “fundamentally modernize” the premarket notification (510(k)) process, through which the agency authorizes the marketing of most medical devices. The reforms — which the agency called “a generational change in the framework for 510(k) devices” — would have a significant impact on most of the medical device industry. ... Read More

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FDA Outlines Sweeping 510(k) Reforms Intended To Steer Manufacturers Toward Continual Innovation

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