FDA promises new AI guidance for medical devices

The FDA has told STAT News it intends to issue new guidance addressing generative AI-powered medical devices, according to the outlet’s Health Tech newsletter. The report, published August 25, does not yet specify a timeline or the guidance’s scope, but frames it as part of the agency’s ongoing effort to establish a regulatory framework for software that generates rather than merely analyzes clinical information.

The same dispatch covers developments from Epic’s Users’ Group Meeting (UGM), the annual gathering where the electronic health records company presents updates to its client base of hospitals and health systems. STAT’s coverage ties the two threads together as parallel signals of how artificial intelligence is being absorbed into the infrastructure of American medicine, one through federal oversight and the other through the commercial platforms that already sit inside most hospital workflows.

Beyond confirming that new FDA guidance is forthcoming and that Epic used UGM to announce updates, the available material does not detail specific rules, products, or dates beyond the story’s own publication. STAT News, a health and life sciences outlet, published the item as part of its subscriber newsletter series on health technology, STAT+.

No further specifics on the guidance’s content have been reported at this time.