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Generative AI Devices The Focus Of First FDA Digital Health Advisory Committee Meeting

 
• By Brian Bossetta

In its inaugural two-day meeting, the FDA Digital Health Advisory Committee discussed the promise of generative AI-enabled medical devices as well as challenges the agency faces in premarket evaluation, benefit/risk analysis, and postmarket monitoring.

US Food and Drug Administration Commissioner Robert Califf kicked off the first meeting of the nascent Digital Health Advisory Committee (DHAC) held Wednesday and Thursday by emphasizing the difficulty of regulating generative AI.

“I have looked far and wide,” Califf told the committee. “I do not believe there is a single health system...

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