MedPage Today November 22, 2024
— Committee’s 2-day meeting focused on evaluating and monitoring performance and risk
A newly assembled FDA advisory committee recommended several approaches to how the agency should handle regulation of generative artificial intelligence (AI)-enabled medical devices during a 2-day meeting that wrapped up Thursday.
The Digital Health Advisory Committee (DHAC) held its first meeting to offer guidance to the FDA on a slew of questions related to the development, evaluation, implementation, and continued monitoring of AI-enabled medical devices.
During the opening remarks, FDA Commissioner Robert Califf, MD, said the DHAC would provide important advice and recommendations on the benefits and risks associated with all digital health technologies, including generative AI-enabled medical devices.
“We’ve established this committee because we see great potential...
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