Pew Comments on Real-World Evidence for Medical Devices

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Pew submitted comments on Oct. 25 to the Food and Drug Administration in response to its draft guidance on the use of real-world evidence to inform regulatory decision-making for medical devices.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.

America’s Overdose Crisis
America’s Overdose Crisis

America’s Overdose Crisis

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