Modernizing the Food and Drug Administration's Premarket Notification Program; Draft Guidances for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidances entitled "Evidentiary Expectations for 510(k) Implant Devices," "Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions," and "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission." FDA is issuing these guidances to improve the predictability, consistency, and transparency of the 510(k) premarket review process. The draft guidances are not final nor are they for implementation at this time.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.