(MedPage Today) – In November, a newly-assembled FDA advisory committee held a 2-day meeting to develop guidance for the agency on questions around generative AI-enabled medical devices. The Digital Health Advisory Committee advocated developing a regulatory approach that focuses on premarket performance evaluation and risk management as well as continuous performance monitoring after these devices are on the market.

However, the committee stopped short of offering specific recommendations, suggesting that regulatory changes are not in the immediate future for healthcare AI. (Read More)