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PolicyHealthUSConfirmed

FDA’s Digital Health Advisory Committee meets on generative AI medical devices

See how this story connects

Source: Federal Register notice 2024-21074

The FDA’s Digital Health Advisory Committee was scheduled to meet on 20-21 November 2024 to advise on total product lifecycle considerations for generative AI-enabled medical devices. The agenda covered premarket performance evaluation, risk management and postmarket monitoring, and a public docket (FDA-2024-N-3924) stayed open for comments until 21 January 2025.

Why it matters

Developers of generative AI medical tools got FDA’s questions on testing and monitoring such devices in public, with a docket open to their comments.

When
20 Nov 2024
ID
WTA-N-2024-0016
Who
FDA

Summary by wheresthe.ai, from Federal Register notice 2024-21074. Checked against the source on 9 Oct 2026.

Read the original at Federal Register notice 2024-21074

Source copy: download the page as saved on 18 Oct 2026 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: Led toFDA proposes a risk framework for generative AI medical devices

Cite this story

WTA-N-2024-0016: “FDA’s Digital Health Advisory Committee meets on generative AI medical devices.” wheresthe.ai, 20 Nov 2024. https://wheresthe.ai/d/us-fda-dhac-generative-ai-devices-meeting-2024-11/ (source: Federal Register notice 2024-21074).

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