FDA Puts AI-Enabled Medical Device Guidance on Its FY2027 A-List

In the United States, guidance on AI-enabled medical devices has moved onto the FDA's main priority list.

On October 1, 2026, the agency published its guidance priorities for fiscal year 2027, Healthcare Dive^[1] reports. The A-list includes the final guidance on marketing submissions and lifecycle management for AI-enabled devices. Next to it is a plan to draft guidance on generative AI.

What the FDA has put on its agenda

The document comes from CDRH, the FDA center that regulates medical devices. RAPS' Regulatory Focus^[2] also covered the agenda.

The format is the same as in past years.

• A-list: final and draft guidances the agency is prioritizing.
• B-list: documents to publish as resources permit.
• A list of documents in progress.

The priority lists include seven final guidances and one draft. One of the seven is carried over from last year's list.

The draft covers the evidence required for generative AI conversational devices for mental health conditions.

This topic was not on the previous list. It follows the request for comments on generative AI regulation that the FDA opened in August.

The guidance on marketing submissions for surgical robots is also on the A-list. The FDA published it in draft form just days earlier. It covers preclinical testing, clinical data and labeling.

A year ago it was on the B-list

The draft guidance on lifecycle management for AI-enabled devices came out in January 2025. On last year's list, finalizing it was a B-list goal.

It now moves off the backup list and into the agency's commitments for the next twelve months.

The legal framework does not change. Under the good guidance practices in 21 CFR 10.115, FDA guidances describe the agency's current thinking and are recommendations. Binding requirements come from device statutes and regulations.

The FDA is accepting comments on the priorities until November 30, 2026.

AI devices need oversight after clearance

The guidance's title links the marketing submission to how the product is managed over time. The focus extends past the day of authorization.

One question comes before any procedure: which role is accountable in writing for the model after launch? A management plan with no named role produces paperwork but leaves accountability unassigned.

Generative AI raises a different issue. The agency has given itself twelve months to set out what evidence it will require from clinical mental health chatbots.

What to decide before the comment period closes

1. Map your products. The inventory separates AI-enabled devices already authorized from those in development, and flags the ones that use generative AI.
2. Name a lifecycle owner. Every model on the market has an accountable role, written into the management plan before release.
3. Consider commenting to the FDA. Companies with products affected by the two guidances submit their own data by November 30. The board's risk committee is told what was decided and when.

Key dates for fiscal year 2027

• October 1, 2026: the FDA publishes its guidance priorities for fiscal year 2027 (United States).
• November 30, 2026: comment period on the priorities closes.
• Next twelve months: target to finalize the AI-enabled device guidance and the surgical robot guidance.
• Same period: target to issue draft guidance on generative AI for mental health conditions.

Until the final version is out, the January 2025 draft remains the reference point.