FDA puts final AI device lifecycle guidance at top of its 2027 priorities

The US Food and Drug Administration published its fiscal 2027 guidance priorities for medical devices on Thursday, with finalising and drafting guidance on artificial intelligence at the top of the list ¹. The agency is accepting feedback on the priorities until Nov. 30 ¹.

What the FDA plans

Over the coming 12 months, the FDA's top priorities include finalising guidance on marketing submissions and lifecycle management for AI-enabled devices, and drafting advice on generative AI ¹. The lifecycle guidance was published in draft in January 2025 ¹. In last year's list, finalising it was only a second-tier objective ¹.

The new draft on generative AI is narrow. The FDA is prioritising evidentiary recommendations on generative AI-enabled conversational devices for mental disorders ¹. MedTech Dive reported that the topic was absent from last year's list and is aligned with an August call from the FDA for feedback on regulating generative AI ¹.

As in previous years, the agency set out a list of priority final and draft guidances, a list it will publish if resources permit and a list of texts under construction ¹. The priority lists hold seven final guidance documents, one of them a holdover from last year, and one draft text ¹. The holdover is guidance on predetermined change control plans for medical devices, which the FDA has yet to finalise but plans to finish in the coming 12 months ¹.

Other priorities for finalisation include premarket submissions for robotically assisted surgical devices, published in draft last week with comments due by Nov. 24 ¹. Texts on air-purifying respirators, menstrual product testing and labelling, quality management systems and the accreditation scheme for conformity assessment are also on the list ¹. Finalising guidance on pulse oximeters, first released in draft in January 2025 after concerns about the effect of skin pigmentation on accuracy, is a second-tier priority ¹.

What it means for the market

For makers of AI-enabled devices, the plan points to final US rules on how to file marketing submissions and manage products across their lifecycle within the coming year, after the draft has been open since January 2025 ¹. Guidance on predetermined change control plans is again on the priority list after it was not finalised last year ¹.

Developers of mental health chatbots face the most direct change. The FDA intends to say what evidence it expects for generative AI conversational devices for mental disorders, a category that had no place on its list a year ago ¹.

The list is a statement of intent. Another priority from last year, on validating certain in vitro diagnostics, has yet to be finalised and does not appear on this year's list ¹.

Comments on the fiscal 2027 priorities close on Nov. 30 ¹.