GUIDANCE DOCUMENT
Evidentiary Expectations for 510(k) Implant Devices Draft Guidance for Industry and Food and Drug Administration Staff September 2023
Not for implementation.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:
- FDA-2023-D-3132
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter 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FDA is issuing this draft guidance to provide our current thinking on 510(k) submissions for implant devices to enhance the predictability, consistency, and transparency of the 510(k) Program. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are intended to serve as a primary resource for all implant devices for which a 510(k) is required, while device-specific guidance documents may provide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.