FDA issues AI-enabled device lifecycle management guidance

On Jan. 6, 2025, the U.S. FDA issued draft guidance for developers of AI-enabled medical devices to bolster the safe, effective development and marketing of these tools throughout their product lifecycles.

If finalized, the guidance would be the first of its kind to incorporate comprehensive recommendations for the design, development, maintenance and documentation of these devices. By prioritizing considerations from the FDA's "Total Product Life Cycle for Medical Devices," the new draft guidance is designed to complement recently finalized guidance on predetermined change control plans for AI- and machine learning-enabled medical devices.

The finalized guidance includes recommendations on how developers can proactively plan for device updates after the product is already on the market.

This week's draft guidance outlines the FDA's current thinking on how to tackle issues like bias and transparency throughout the AI-enabled device lifecycle, particularly within the context of risk management.

To that end, the guidance provides recommendations to help developers demonstrate how they have assessed each tool for bias risks. Further, the guidelines provide insights into how and when developers should describe the postmarket performance monitoring and management of their AI-enabled devices in marketing submissions.

"The FDA has authorized more than 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 Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health, in a press release. "[This] draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices and provides a first point-of-reference for specific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The FDA is seeking public comment on this draft guidance by April 7, 2025, with a specific request for comments on the draft's alignment with the AI lifecycle, how well its recommendations address concerns around emerging technologies like generative AI, its approach to performance monitoring for AI-enabled devices and how information about these devices should be conveyed to users.

Alongside this draft guidance, the agency also recently published recommendations for the use of AI in supporting drug development, in addition to guidance on including tissue biopsies in clinical trials and improving the accuracy of pulse oximeters across skin tones.

Shania Kennedy has been covering news related to health IT and analytics since 2022.