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Latest / Health and life sciences

PolicyHealthUSConfirmed

FDA issues draft lifecycle guidance for AI-enabled medical devices

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Source: FDA

The FDA issued draft guidance with recommendations for AI-enabled medical devices across the total product lifecycle, covering design, development, maintenance, documentation, transparency and bias, and what sponsors should include in marketing submissions. The FDA said it had authorised more than 1,000 AI-enabled devices.

Why it matters

Makers of AI medical devices have one FDA reference for what to document from design to post-market, alongside the final guidance on pre-approved change plans.

When
6 Jan 2025
ID
WTA-N-2025-0172
Who
FDA

Summary by wheresthe.ai, from FDA. Checked against the source on 9 Oct 2026.

Read the original at FDA

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

Next stop on this Storyline: What happened nextFDA loosens oversight of AI decision-support software and health wearables

Cite this story

WTA-N-2025-0172: “FDA issues draft lifecycle guidance for AI-enabled medical devices.” wheresthe.ai, 6 Jan 2025. https://wheresthe.ai/d/us-fda-ai-device-lifecycle-draft-guidance-2025-01/ (source: FDA).

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