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CDRH Drops Seven Divisive 510(k) Proposals; Congress Picks Some Up

The device center is dropping seven controversial 510(k) reform-related proposals, including creating a “class IIb” category of devices, following pushback from industry. But some of the matters are under consideration on Capitol Hill.

CDRH will not independently move forward with any of the seven controversial 510(k) reform recommendations that were sent to the Institute of Medicine for consideration last year, Center Director Jeffrey Shuren said in an interview. But some have reemerged in Congress, he added.

The seven proposals, including creating a new “class IIb” category of moderate-risk devices and developing guidance detailing when a device should no longer be used as a 510(k) predicate, were...

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