FDA Says Generative AI Device Guidance Is Coming, Signaling A More Formal Policy Phase

The Food and Drug Administration says it is developing a plan for how to regulate medical devices that use generative artificial intelligence, with formal policy guidance intended to clarify the agency’s approach.

Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT that the FDA plans to release documents spelling out agency policies regarding the technology. “Our goal is formal policy guidance,” Abramson said.

He added that the ecosystem should expect not only broad guidance on generative AI overall, but also narrower specialty guidance on particular generative AI topics of special interest or special complexity.

Why it matters

The immediate signal is procedural rather than product-specific: developers now have a clearer indication that the agency intends to move beyond case-by-case signaling toward written policy. For companies building device software with generative AI components, that can shape development planning, evidence generation and regulatory strategy before a submission is filed.

Abramson’s comments do not set a timeline or define the contents of the future documents. But the commitment to both broad and topic-specific guidance suggests the FDA sees generative AI as a category that may need more than one umbrella framework.

That distinction matters because generative AI raises different questions depending on how it is used in a medical device. The FDA is signaling that at least some of those questions may be addressed through narrower guidance instead of relying only on one general statement of policy.