FDA Issues Draft Guidance for Development of AI-Enabled Medical Devices

January 6, 2025—The FDA announced it has issued draft guidance for recommendations to support development and marketing of safe and effective artificial intelligence (AI)–enabled devices throughout the device’s Total Product Life Cycle. The FDA will hold a webinar on February 18, 2025, to discuss the draft guidance.

The FDA is requesting public comment on this draft guidance to be submitted by April 7, 2025.

In addition to general comments, the FDA is specifically requesting public comment on the draft guidance’s alignment with the AI lifecycle; the adequacy of the recommendations to address concerns that may be raised by emerging technology such as generative AI; the approach to performance monitoring (including use of a performance monitoring plan as a means of risk mitigation for AI-enabled devices); the type of information about AI-enabled devices that should be conveyed to users; and the most appropriate approach to deliver that information.

According to the FDA, the guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance, and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices.

The agency stated that this guidance complements the recently issued final guidance on predetermined change control plans for AI-enabled devices, which provides recommendations on how to proactively plan for device updates once the product is on the market.

As summarized in the FDA press release, the draft guidance includes:

• Proposed recommendations for how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices.
• The FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices.
• Specific recommendations intended to help a sponsor demonstrate they have addressed risks associated with bias and provides suggestions for the thoughtful design and evaluation of AI-enabled devices.

Sponsors are encouraged to engage with the agency early and often, and to use this guidance, once finalized, to guide their activities throughout the life cycle of the device, including during planning, development, testing, and ongoing monitoring, advised the FDA.

Troy Tazbaz, Director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health, commented on this development in the FDA press release.

“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways,” stated Mr. Tazbaz. “As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices.”

Mr. Tazbaz continued, “Today’s draft guidance brings together relevant information for developers; shares learnings from authorized AI-enabled devices; and provides a first point-of-reference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire life cycle.”

Also on January 6, the FDA announced the publication of draft guidance with recommendations regarding the use of AI to support development of drug and biological products.