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GUIDANCE DOCUMENT

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission Draft Guidance for Industry and Food and Drug Administration Staff September 2023

Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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-3134
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FDA is issuing this draft guidance to provide our current thinking on the use of best practices in selecting a predicate device in 510(k) submissions to enhance the predictability, consistency,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 FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance propose factors for consideration as best practices for choosing a predicate device that focus on characteristics of the predicate, including selecting a predicate device that was cleared using well-established methods, meets or exceeds expected safety and performance, is without unmitigated use-related or design-related safety issues, and is without an associated design-related recall. FDA believes use of these best practices will encourage the evolution of safer and more effective medical devices in the 510(k) Program over time.

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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-3134.

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