FDA Issues Draft Guidance for Developers of AI-Enabled Devices

The U.S. Food and Drug Administration (FDA) has issued draft guidance that features recommendations to support development and marketing of safe, effective artificial intelligence (AI)-powered medical devices throughout the device’s Total Product Life Cycle (TPLC).

If finalized, this would be the first guidance with comprehensive recommendations for AI-enabled devices throughout the TPLC. This way, developers would have an accessible set of considerations that bring together design, development, maintenance, and documentation recommendations for AI-enabled devices.

The guidance complements the agency’s recently released final guidance on predetermined change control plans for AI-enabled devices. It offers recommendations about proactive planning for device updates once the product hits the market.

Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health said the FDA has authorized over 1,000 AI-enabled devices through established premarket pathways.

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,” said Tazbaz. “Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific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.”

The guidance includes recommendations for how and when, in marketing submissions, sponsors should describe postmarket performance monitoring and management of their AI-enabled devices. The FDA said the proposed recommendations reflect its comprehensive approach to managing risk throughout the device TPLC.

Specific recommendations in the guidance also describe how sponsors can demonstrate they’ve addressed risks related to bias and offer suggestions for thoughtful AI-enabled device design and evaluation.

The FDA is requesting comment on the draft guidance by April 7, 2025.