FDA to Accept De-Identified Real-World Evidence for Select Medical Device Applications

FDA removes patient-identifiable RWE requirement for device submissions

The US Food and Drug Administration (FDA) is removing a limitation on the use of real-world evidence (RWE), clearing the way for de-identified data to be used for medical device submissions.The post FDA removes patient-identifiable RWE requirement for device submissions appeared first on Medical Device Network.

FDA to Accept De-Identified Real-World Evidence for Select Medical Device Applications

Today, the FDA issued new guidance allowing de-identified real-world evidence in certain medical device applications, removing a barrier to using large data sources.

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews. In new guidance for certain types of medical device submissions, the agency states it will accept RWE without requiring that identifiable individual patient data collected from real-world data sources always be submitted in a marketing submission. The FDA similarly intends to consider up…