Pew Comments on Real-World Evidence for Medical Devices

Pew submitted comments on Oct. 25 to the Food and Drug Administration in response to its draft guidance on the use of real-world evidence to inform regulatory decision-making for medical devices. Pew supports two key policy changes: the incorporation of unique device identifiers into relevant real-world data sources like claims forms so that potentially faulty devices can be tracked; and the development of a national device evaluation system, known as the National Evaluation System for Health Technology, that can pull data from multiple locations to obtain more comprehensive information on patient outcomes.