Published Aug 18, 2026, 5:29 AM ET · Updated 3 months ago · 1 source

Exclusive: FDA considers assessing AI devices like doctors

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Exclusive: FDA considers assessing AI devices like doctors

The Food and Drug Administration is considering evaluating generative AI-enabled medical devices through a "competency-based approach," similar to how doctors are evaluated, the agency writes in a discussion paper first shared with Axios.