The Department of Health and Human Services is setting up two new FDA leadership roles. One would cover technology and AI, the other prescription drugs. The plan was first reported by CNBC, which cited unnamed officials.
The technology post would oversee both how the FDA uses AI internally and how the agency reviews AI-enabled medical products. Jared Seehafer, a senior FDA advisor and medical device industry veteran, is the front-runner, the report said. Enzyme, a software startup he founded, served life sciences clients with compliance tools. He later shifted to a San Francisco venture firm, then into the FDA last year.
No candidates have been named for the drugs role. Both new roles would sit under Heidi Overton, the president’s pick to run the FDA. The Senate has not yet confirmed her. The department sees the new posts as leverage over the agency, the report said.
The FDA already leans on AI internally. Its in-house generative AI tool, Elsa, helps staff condense documents and prepare written responses. Last week the agency released a discussion paper on regulating generative AI-enabled medical devices. It is collecting comments from patients, developers and clinicians before writing formal guidance.
AI oversight is becoming a structural priority at the FDA, not a side project. If confirmed, the new technology deputy would be the most senior official dedicated to AI at the agency.
