AI/ML & Medical Devices: Draft FDA Guidance

The recent explosion of medical devices using artificial intelligence (AI) and machine learning (ML) has prompted new draft guidelines from the US Food and Drug Administration (FDA).

The recommendations – released online for feedback in April – detail how AI/ML device innovators can provide predetermined change control plans (PCCPs) as part of their applications to the FDA. This thereby enables such devices to be quickly and safely modified and improved as new data comes to hand.

“The approach the FDA is proposing in this draft guidance would put safe and effective advancements in the hands of health care providers and users faster, increasing the pace of medical device innovation in the United States and enabling more personalized medicine,” said the FDA in a press statement.

“In addition to across-the-board, or ‘global’, device updates, under the proposed approach, AI/ML-enabled devices could be more extensively and rapidly modified to learn and adapt to local conditions.”

As of October 2022, the FDA had already approved over 500 AI/ML-enabled medical devices. A full list of approved applications is available via the FDA website.

Read the new draft FDA guidelines here, or find a summary via the Regulatory Affairs Professionals Society.