What To Watch: FDA Shifts Attention On Artificial Intelligence

In an interesting and somewhat unexpected turnabout over the last six months, FDA has pivoted its focus from regulating industry's use of artificial intelligence ("AI") to how the agency itself utilizes AI. This internal shift marks a departure from FDA's development of AI guidance over the last few years.

2024 marked an active year for AI regulation by FDA, with establishment of the CDER AI Council as well as the development and release of various white papers and guidance documents. Even at the beginning of 2025, FDA released much-anticipated drug and device guidance documents. As the agency has undergone transformation in the first half of 2025, it has been notably quiet on the release of policy statements or guidance documents impacting the industry's use of AI. Instead, FDA announced in May a short timeline to scale the use of AI internally across FDA's various centers, and in early June, rolled out Elsa, an AI tool to, among other uses, accelerate clinical