FDA AdComm to discuss patient-centric informed consent

By Laura DiAngelo, MPH

The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large. The meeting, scheduled for October 2024, will seek input and recommendations from the committee on the process for informed consent, “new areas of focus” for informed consent, and recent policy on “key information.”

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