Lexology December 9, 2025
The U.S. Food and Drug Administration (FDA) announced it is using various artificial intelligence tools to use in premarket reviews and for other purposes, including post-market surveillance, inspections, and administrative functions. This initiative aligns with the Trump administration’s “OneHHS” AI strategy, which promotes integration of machine learning technologies across agencies to streamline workflows and enhance cybersecurity, including facilitating reproducible medical product pipelines.
FDA’s brief announcement specifies the agency will use “Agentic AI” – which are AI systems “designed to achieve specific goals by planning, reasoning, and executing multi-step actions” – for more ”complex tasks” than previous uses of AI within the agency, such as:
- premarket review
- review validation
- post-market surveillance
- meeting management
- inspections and compliance and administrative functions.
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