FDA gives all staff agentic AI tools for premarket reviews and inspections
On December 1, 2025, the FDA said it had deployed agentic AI tools, which can plan and carry out multi-step tasks, to all of its employees. The agency listed uses including meeting management, premarket reviews, review validation, postmarket surveillance, inspections and compliance. Use is voluntary, and the models run in a secure GovCloud environment. The FDA says they do not train on staff inputs or on industry submissions. It also says all AI output is checked by staff before it goes into any regulatory action. The rollout builds on the Elsa generative AI tool launched in May 2025, which the agency says more than 70% of staff use.
Why it's notable: The regulator that clears drugs and devices is now putting AI agents into its own review work. That could affect how fast, and how consistently, applications from device makers and drug sponsors are handled.