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De Novo Draft Guidance: FDA Review With No 510(k) Submission

FDA releases an update of its draft de novo classification guidance Aug. 14 to comport with FDA Safety and Innovation Act, and permit manufacturers to submit de novo applications for review without a preceding 510(k) submission.

CDRH has revised its draft guidance on the de novo classification process to align it with the FDA Safety and Innovation Act’s provisions that allow submission of de novo devices without a preceding 510(k) submission.

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