Noesion Radarnoesion.ai
Regulation2026-08-24

The US Food and Drug Administration is preparing formal written guidance on how it will regulate medical devices that use generative AI, according to Rick Abramson, who directs the agency's Digital Health Center of Excellence. He said the agency plans both broad guidance on the technology and narrower documents on particular topics it considers complex, and is weighing a competency-based approach. No timeline or draft text was given.

What changed

The FDA had not committed publicly to formal guidance covering medical devices built on generative AI.

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