Patient Engagement in Medical Device Clinical Trials Discussion Document


The National Health Council (NHC) is pleased to provide comments on the Food and Drug Administration (FDA)’s solicitation for feedback on patient engagement in medical device clinical trials, including the Center for Devices and Radiological Health (CDRH) Patient Engagement Advisory Committee (PEAC)’s Discussion Document from its November 15, 2018, meeting. The NHC appreciates the opportunity to provide input to the FDA on this important topic and supports CDRH’s plans to develop draft guidance on patient engagement in clinical trials in FY2019.

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