FDA Expands Use of Real-World Evidence (RWE) in Medical Device Reviews

“The U.S. FDA has updated its approach to Real-World Evidence (RWE) by allowing the use of de-identified patient data in drug and medical device application reviews, removing a major barrier to broader RWE adoption.

Previously, FDA requirements for identifiable patient information limited the use of large-scale healthcare databases and slowed the growth of real-world evidence programs, despite more than 250 medical device reviews using RWE methods since 2016.

Under the revised approach, the FDA will now accept de-identified data sources, including disease registries, insurance claims databases, and Electronic Health Records (EHRs), to support regulatory decision-making.

The agency will evaluate submissions using an “application-by-application” approach, focusing on the scientific validity, reliability, and evidentiary quality of the data rather than the presence of personally identifiable information.

This change is expected to improve the use of real-world data in regulatory reviews, enhance representation across patient populations, and strengthen evidence generation for certain medical devices, with possible expansion into additional regulatory areas in the future.

Region: Taiwan, United States