CDRH's FY2027 guidance agenda lists AI-enabled device software and generative AI mental-health devices
A guidance agenda is a plan, not guidance. CDRH's FY 2027 lists name final guidance on AI-enabled device software functions, a draft on generative AI conversational devices for mental disorders, and a generative AI risk topic still under construction.
Bottom line: The FY 2027 lists are a non-binding statement of what CDRH intends to publish or develop. No AI-device guidance is issued by this page, and CDRH invites comments by November 30, 2026.
Who this affects: Medical device and digital-health makers, regulatory affairs teams, health-system buyers of AI-enabled devices, and FDA counsel.
Issue date: The FDA page shows content current as of 1 October 2026. It does not state a separate publication date.
What changed: CDRH shared its FY 2027 lists. The AI items are final guidance on AI-enabled device software functions and on predetermined change control plans, a draft on generative AI conversational devices for mental disorders, and an Under Construction topic on generative AI-enabled devices.
Analysis: In our reading, the useful signal is topic and priority, not content. Nothing on the lists says what the guidances will recommend, and CDRH itself reports that it published 7 of 11 guidances on its FY 2026 list.
- Instrument (English)
- CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027), A-list, B-list and Under Construction list
- Authority
- U.S. Food and Drug Administration, Center for Devices and Radiological Health (CDRH)
- Jurisdiction
- United States (federal)
- Status
- Published planning list. Comments invited by November 30, 2026
- Bindingness
- Not applicable (non-binding). The lists identify guidance CDRH intends to publish or develop; they are not guidance themselves
- Issue date
- Not stated in the source as a publication date. The FDA page shows "Content current as of: 10/01/2026"
- Effective date
- Not applicable (non-binding). Fiscal year 2027 is the period for which CDRH plans to publish
- What changed
- CDRH shared its FY 2027 lists, which name AI-enabled device software functions, predetermined change control plans, generative AI mental-health devices and generative AI risk and evidence as topics
- Who this affects
- Medical device and digital-health makers, regulatory affairs teams, health-system buyers of AI-enabled devices, and FDA counsel
- Primary source
- FDA, CDRH Proposed Guidances for Fiscal Year 2027
- Workflow impact
- None required. Teams with AI-enabled device software in development can use the lists to anticipate topics and timing, which the source does not fix
- Operational next step
- Decide whether to file comments in docket FDA-2012-N-1021 before November 30, 2026, and track the listed titles
- Last verified
- 2026-10-25
Primary source: FDA, CDRH Proposed Guidances for Fiscal Year 2027
Key takeaways
- The lists are plans. CDRH says the A-list identifies "the priority guidance documents CDRH intends to publish during FY 2027".
- The A-list final topics include AI-enabled device software functions and predetermined change control plans.
- The A-list draft topic is generative AI-enabled conversational devices for mental disorders, with evidentiary recommendations.
- Comments are invited by November 30, 2026, in docket FDA-2012-N-1021.
What did CDRH publish, and is it guidance?
CDRH published its proposed guidance lists for fiscal year 2027. The FDA page says CDRH is sharing lists of guidance documents that it intends to publish in FY 2027 or intends to develop. There are three lists. The A-list holds the priority guidance CDRH intends to publish in FY 2027. The B-list holds guidance CDRH intends to publish "as resources permit" during FY 2027. The Under Construction list holds guidance CDRH intends to develop as resources permit that is not on the A- or B-list.
None of this is guidance. The lists name titles only. They carry no recommendations, no definitions and no dates for individual documents. The FDA page shows content current as of 1 October 2026, and we have not found a separate publication date in the source.
Which AI items are on the lists?
The attached PDF lists these AI-related titles.
| List | Type | Title as listed |
|---|---|---|
| A-list | Final | Marketing Submission and Lifecycle Management Recommendations for Artificial Intelligence-Enabled Device Software Functions |
| A-list | Final | Predetermined Change Control Plans for Medical Devices |
| A-list | Draft | Generative Artificial Intelligence-Enabled Conversational Devices for Mental Disorders: Evidentiary Recommendations |
| Under Construction | Not typed | Risk Assessment and Evidentiary Considerations for Generative Artificial Intelligence-Enabled Devices |
Two nearby B-list draft topics also concern device software: "Policy for Device Software Functions", whose title the PDF notes has changed from "Policy for Device Software Functions and Mobile Medical Applications", and "Postmarket Management of Cybersecurity in Medical Devices". The PDF does not say these are AI items.
The titles show how CDRH frames the work. The AI-enabled software title uses "Marketing Submission and Lifecycle Management Recommendations". The mental-health title uses "Evidentiary Recommendations". Those phrases are CDRH's own labels, and the lists do not describe what the documents would contain.
How firm is the timetable?
Not very. An A-list placement is an intention for FY 2027, and the page gives no date for any single document. CDRH reports that in FY 2026 it "published 7 of 11 guidances on the FY 2026 list (5 from the A-list, 2 from the B-list)". It also says feedback on the FY 2026 list "was mostly in agreement". A reader can take from this that a listed item is a reasonable planning signal, and that some listed items do not arrive in the year named.
| Date | What the FDA page says |
|---|---|
| 1 October 2026 | "Content current as of" date shown on the FDA page. It is not stated as a publication date. |
| 30 November 2026 | CDRH appreciates comments on any of the guidance documents on the lists by this date, in docket FDA-2012-N-1021. |
| Fiscal year 2027 | Period in which CDRH intends to publish the A-list documents and, as resources permit, the B-list documents. No date is given for any single document. |
The page also says CDRH is "seeking comments on the relative priority of guidance documents on the A-list and B-list", and welcomes suggestions for new or different guidance documents. The ranking is therefore open to comment.
What does it mean for device makers, regulatory teams and buyers?
For makers of AI-enabled device software and regulatory affairs teams, the lists show which topics CDRH has put forward for FY 2027, including predetermined change control plans and generative AI. In our reading, they do not themselves change any current submission requirement. For makers of conversational products aimed at mental disorders, the A-list draft is the entry to watch, and the Under Construction generative AI risk topic is a second one. For health-system buyers, the lists give a basis for asking vendors how they are tracking these topics. They are not a standard to hold vendors to.
What to do now:
- Map each AI feature in your pipeline to the four listed titles, and record which ones you think are in scope.
- Decide whether to file a comment in docket FDA-2012-N-1021 by November 30, 2026, on priority or on proposed policy.
- Keep working from the guidance CDRH has already published and the statutes and regulations that apply to your device, and treat the listed items as pending.
- Set a review date for when CDRH posts a draft or final document, and read the document itself then.
FAQ
Is the CDRH FY2027 agenda binding guidance?
No. CDRH describes the lists as guidance documents it intends to publish or develop in fiscal year 2027. The agenda is a plan. It sets no requirement for device makers, and listed items can change or slip.
Which AI topics are on the FY2027 A-list?
The A-list final guidance topics include "Marketing Submission and Lifecycle Management Recommendations for Artificial Intelligence-Enabled Device Software Functions" and "Predetermined Change Control Plans for Medical Devices". The A-list draft topic is "Generative Artificial Intelligence-Enabled Conversational Devices for Mental Disorders: Evidentiary Recommendations".
What is on the Under Construction list for generative AI?
"Risk Assessment and Evidentiary Considerations for Generative Artificial Intelligence-Enabled Devices". CDRH says Under Construction items are guidance it intends to develop as resources permit and that are not on the A- or B-list.
When can the public comment, and where?
CDRH says it appreciates comments by November 30, 2026, submitted electronically at www.regulations.gov under docket number FDA-2012-N-1021.
Does the agenda say when each guidance will be published?
The FDA page and the attached PDF list topics but state no publication date for any item. The A-list is described as the priority guidance CDRH intends to publish during FY 2027.
What we did not verify
What we opened: the FDA page "CDRH Proposed Guidances for Fiscal Year 2027 (FY 2027)" and the PDF attached to it, on 25 October 2026 UTC. The page shows content current as of 10/01/2026.
What we did not open: the docket on regulations.gov, the "Notice to Public of Website Location of CDRH Fiscal Year 2027 Proposed Guidance Development", any earlier FDA guidance on the same subjects, and any trade-press report of the release. We did not confirm a publication date apart from the page's current-as-of date.
What we refuse to claim: what any listed guidance will recommend, when any item will be published, that an item will be issued in FY 2027, or that the lists bind anyone.
The CDRH FY 2027 agenda is a non-binding plan. Treat the AI-enabled software, change control plan and generative AI mental-health titles as topics to watch, consider commenting by November 30, 2026, and look to the applicable statutes, regulations and already published guidance, not this list, for what applies to your device today.
Related briefings
Source File
Secondary: The PDF attached to the primary page, CDRH Proposed Guidances for Fiscal Year 2027.
Last checked: 2026-10-25 (UTC)
Status: Published planning list, not binding.
Editorial note: Informational analysis for working professionals, not legal advice. Confirm how any rule applies to your situation with qualified counsel.
Informational analysis for working professionals, not legal advice. Confirm how any rule applies to your situation with qualified counsel.
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