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Quality System Certification Would Supplant Some 510(k)s In Updated House Bill

Committee-approved 21st Century Cures legislation includes a revised third-party quality system assessment provision that would allow certain types of modifications to 510(k) devices without a new submission if the firm's quality system has been specially certified by a third-party auditor.

Device companies could bypass 510(k) submissions for certain product modifications if they are certified by a third-party quality system audit under legislation that unanimously passed through the House Energy and Commerce Committee May 21.

The ambitious 21st Century Cures bill is now set to move to the House floor, and bipartisan sponsors hope for a vote by the end of the year. The legislation,...

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