FDA streamlines approval of AI-powered devices

The Food and Drug Administration on Tuesday finalized recommendations aimed at simplifying the process for approving medical devices that use artificial intelligence.

Why it matters: Regulators increasingly are evaluating AI-powered medical devices.

• Artificial intelligence and machine learning has the potential to improve health care by ingesting real-world data and adapting it to new circumstances in real time.
• But ensuring that AI-powered medical devices remain safe and effective is burdensome for both the FDA and manufacturers.
• "This guidance is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices," the FDA memo says.

Zoom in: The first-time guidelines outline that manufacturers can seek approval to make changes to their AI-enabled products without having to file a new submission to show the device is safe and effective.

• The plan is submitted to FDA along with a marketing approval application that outlines modifications that will be made and how those changes will be assessed.
• Regulators said manufacturers should include descriptions of planned changes to the device, outline the testing needed to make sure the device remains safe and effective, and a risk-mitigation strategy.
• FDA proposed initial guidelines in April 2023.

Reality check: The guidelines are recommendations, not legally enforceable requirements.