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Evidentiary Expectations for 510(k) Implant Devices Draft Guidance for Industry and Food and Drug Administration Staff September 2023


Not for implementation. Contains non-binding recommendations.

Docket Number:
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FDA is issuing this draft guidance to provide our current thinking on 510(k) submissions for implant devices to enhance the predictability, consistency, and transparency of the 510(k) Program. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are intended to serve as a primary resource for all implant devices for which a 510(k) is required, while device-specific guidance documents may provide further specificity for a given device type. The recommendations are intended to promote consistency and facilitate efficient review of 510(k) implant devices.

Submit Comments

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-3132.

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