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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
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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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FDA is issuing this draft guidance to provide our current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k)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 FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are consistent with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance, and provide additional clarity and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.