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 protocol reviews, scientific evaluations, and identify high-priority inspection targets. The way in which Elsa will affect FDA’s processes and timelines is certainly an area to keep any eye on.
Also, as FDA continues to prioritize its internal use of AI, the gap created by FDA’s deceleration on industry regulation and the continued emergence of state AI laws impacting industry is creating a tension that requires attention from in-house privacy, legal and compliance teams.