What it is

FDA announced this draft guidance on 6 January 2025 and published it on 7 January 2025 (docket FDA-2024-D-4488). FDA said that, if finalized, it would be the first guidance to give comprehensive recommendations across the total product lifecycle of AI-enabled devices, from design and development through postmarket monitoring.

The draft covers what marketing submissions should include about the device and its AI, with attention to transparency and bias, and to plans for postmarket performance monitoring. FDA held a webinar on 18 February 2025; the comment request closed on 7 April 2025, and FDA specifically asked whether the guidance addresses generative AI.

At announcement, FDA said it had authorized more than 1,000 AI-enabled devices.

Status

As of FDA’s digital health guidance list (April 2026), it is still a draft. Related documents:

  • PCCP guidance for AI-enabled device software functions: final (see the PCCP article).
  • Clinical Decision Support Software guidance: final, 29 January 2026.

Reuse terms

FDA content is public domain unless otherwise noted; credit is appreciated and FDA suggests noting the date copied. The official link is a press announcement, so index the draft guidance text itself, not only the press release.

Using the draft in AI and RAG

  1. Index the draft text, labeled Draft, with docket and date.
  2. Keep the press release separate as context only.
  3. Tag sections for device description, data, validation, transparency, bias, and postmarket monitoring.
  4. Link to the final PCCP guidance for change planning.
  5. Monitor for finalization and re-index when it happens.

Common mistakes

  • Citing the press release instead of the guidance.
  • Treating draft recommendations as final requirements.
  • Ignoring postmarket monitoring plans in submissions.
  • Assuming the draft addresses generative AI in detail; FDA asked for comments on that point.

Checklist

  • Draft text indexed with status
  • Press release stored separately
  • Sections tagged for gap checks
  • PCCP guidance linked
  • Finalization monitored

How AskDona helps

AskDona compares your AI device submission content with the draft’s recommendations and shows, section by section, where your documentation provides evidence.

Run a sample AI device submission check

AskDona shows the evidence; your regulatory team decides.

Editor’s note. This article is general information, not legal advice. The “conditions to check” rating comes from our source list and is a first-pass judgment, not a legal opinion.

FAQ

Is FDA’s AI device lifecycle guidance final? No. It was issued as a draft in January 2025 and remained a draft as of April 2026.

What does it cover? Total product lifecycle recommendations for AI-enabled devices, including transparency, bias, and postmarket monitoring.

How many AI-enabled devices has FDA authorized? More than 1,000, as FDA stated in January 2025.

Does it address generative AI? FDA asked for public comment on whether it does.

References

All pages opened and checked by October 26, 2026.

SourceWhat it supports
FDA: Press announcement, 6 Jan 2025Announcement, scope, 1,000+ devices
FDA: Draft guidance pageDraft status, docket
FDA: Digital health guidancesStatus as of April 2026, CDS final
FDA: Website policiesPublic domain reuse