FDA to Issue Formal Guidance on Regulating Generative AI Medical Devices

The Food and Drug Administration announced that it is creating a plan to regulate medical devices that incorporate generative artificial intelligence. Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT the agency will eventually release documents that spell out its policies on the technology.

Abramson said the agency aims to provide formal policy guidance that addresses the whole field while also offering more narrowly focused guidance for particularly complex or specialized generative AI topics.

The comments were made in an interview with STAT, reflecting the industry’s expectation for clearer rules as the ecosystem prepares for the upcoming regulatory framework.