Docket Number:
FDA-2023-D-4395
Issued by:

Guidance Issuing Office

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

Download the Current Final Guidance Download the Revised Final Guidance

FDA recognizes and anticipates that the Agency and industry may need up to 60 days to perform activities to operationalize the recommendations within this guidance. For regulatory submissions that are currently pending with FDA after publication of the guidance, as well as those submissions received within 60 days following publication of the guidance, FDA generally does not anticipate that sponsors will be ready to include the newly recommended information outlined in the guidance in their submission. FDA, however, intends to review any such information if submitted at any time.

FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This guidance includes expanded and updated recommendations to FDA staff and sponsors considering using RWE to support a regulatory submission for medical devices. This document supersedes the final guidance of the same name, issued August 31, 2017.

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-4395.