1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff December 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-4395
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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

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-4395.

Back to Top