FDA Plans New Review Framework for AI-Based Medical Devices

An April 2 Statement from Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), announced that the FDA is considering creating a new review framework to promote development of medical devices that use artificial intelligence (AI) algorithms. The FDA also released a Discussion Paper and Request for Feedback on the proposed regulatory framework.

The FDA has already authorized the use of AI software in medical devices to help screen for diseases and provide treatment recommendations. The few AI technologies that have been cleared by the FDA thus far, referred to as “locked” algorithms, don’t continually adapt or learn every time the algorithm is used. Instead, they need to be modified periodically by the device’s manufacturer, and each modification may require a new FDA clearance. In contrast, machine learning algorithms that continually evolve, called “adaptive” or “continuously learning” algorithms, do not require manual modification, but under current regulation each new adaptation might still require FDA review.

The FDA hopes that a new regulatory approach would “enable the evaluation and monitoring of a software product from its premarket development to post-market performance” and “allow the FDA’s regulatory oversight to embrace the iterative nature of these artificial intelligence products while ensuring that our standards for safety and effectiveness are maintained.”