FDA Issues Three Guidances on Premarket Notification [510(k)] Program
On September 7, 2023, the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issued three new draft guidance documents addressing premarket notification [510(k)] submissions for medical devices:
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission (Docket Number: FDA-2023-D-3134);
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions (Docket Number: FDA-2023-D-3133); and
- Evidentiary Expectations for 510(k) Implant Devices (Docket Number: FDA-2023-D-3132).
These draft guidances are part of the FDA’s ongoing efforts to modernize the 510(k) Program (described in its Medical Device Safety Action Plan) as it implements the Medical Device User Fee Amendments 2022 (MDUFA…
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