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GUIDANCE DOCUMENT

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions Draft Guidance for Industry and Food and Drug Administration Staff September 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-3133
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this draft guidance to provide our current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are consistent with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance, and provide additional clarity and context for situations when clinical data may be necessary to demonstrate substantial equivalence. The recommendations are intended to advance safety and innovation as well as promote consistency and facilitate efficient review of 510(k) submissions that include clinical data.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-3133.

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