FDA drafts roadmap for regulating generative AI medical devices STAT News | August 25, 2026

https://geneticliteracyproject.org/2026/08/25/fda-drafts-roadmap-for-regulating-generative-ai-medical-devices/ The FDA is drafting a first-ever policy roadmap for regulating medical devices powered by generative AI, according to STAT News reporter Mario Aguilar. “Our goal is formal policy guidance,” said Rick Abramson, director of the FDA’s Digital Health Center of Excellence, describing the discussion paper the agency recently released.