Inaugural Meeting for FDA’s Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

Lexology November 12, 2024
Jones Day

The U.S. Food and Drug Administration’s (“FDA”) new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative artificial intelligence (“GenAI”) at its initial meeting, receiving stakeholder insight regarding premarket performance evaluation, risk management, and postmarket performance monitoring.

FDA’snew Digital Health Advisory Committee (“DHAC”) will hold its first meeting on November 20-21, 2024, in Gaithersburg, Maryland, to discuss total product lifecycle considerations for GenAI-enabled medical devices, including how the use of artificial intelligence may impact the safety and effectiveness of medical devices and approaches to regulation. The newly constituted DHAC includes nine voting members; FDA may, but is not required to, supplement the DHAC with temporary,...

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