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

Issue Date: December 18, 2025
Issued by: Center for Devices and Radiological Health
Topic(s): Postmarket, Premarket, Real World Data / Real World Evidence (RWD/RWE),
Status: Final

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

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.

Download the Guidance Document