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FDA agenda for 2027: final AI lifecycle guidance planned, but no date set

RA & medtech

FDA plans to finalise its AI lifecycle guidance in fiscal year 2027 but gives no date; you can comment on the agenda until 30 November.

Source: CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027) (FDA),

Note: I provide engineering services in regulatory affairs for medical devices.

Technical drawing: on the left a draft sheet from January 2025, a dashed arrow leads to a final document above fiscal year 2027, and a question mark leaves its date open. The comment deadline of 30 November 2026 is marked on the timeline.

What happened: On 1 October 2026, CDRH, the US Food and Drug Administration’s centre for medical devices, published its list of planned guidances for fiscal year 2027, which runs until 30 September 2027. The A-list, the priority guidances, includes the final version of the guidance on marketing submissions and lifecycle management for AI-enabled device software functions. The draft dates from 7 January 2025 and, according to FDA’s guidance page, is still not final. Also on the A-list: the guidance on predetermined change control plans (PCCPs, pre-authorised plans for future changes) for medical devices in general and, as a draft, a guidance on generative AI conversational devices for mental disorders. The guidance on risk assessment for generative AI, by contrast, is only on the “Under Construction” list, meaning topics FDA intends to work on as resources permit.

What this means: The final version is planned, but not scheduled. FDA itself says it may be unable to publish every guidance on the lists and that priorities are subject to change at any time. Of the guidances on the 2026 list, 7 out of 11 were published. Until the final version appears, I see the non-binding draft as the best guide for submissions with AI software, even though the final text may differ.

What you can do:

  1. Look for gaps now: Check your AI documentation against Appendix A of the draft. Its table shows where each topic belongs in the submission, for example device description, risk assessment, data management, validation and device performance monitoring.
  2. Don’t plan around a date: Base submissions on the draft and keep time free to check them against the final version once it appears.
  3. Comment on priorities: FDA explicitly asks for feedback on which guidances should come first. Comments go through regulations.gov to docket FDA-2012-N-1021 by 30 November 2026, according to FDA.

Context: If you are planning generative AI in a device, don’t wait for the risk assessment guidance. It is on neither of the two lists of guidances FDA intends to publish in fiscal year 2027.

What does this mean for your team? Let’s talk it through. Request an intro call