FDA announces agentic AI capabilities for employees

The FDA has introduced agentic AI to its workforce, aiming to facilitate more complex workflows and improve operational efficiency, with high-security measures ensuring data safety.
Dec. 2, 2025

The U.S. Food and Drug Administration (FDA) has expanded artificial intelligence (AI) offerings for employees with the addition of agentic AI, according to an announcement.

The goal of this action is to “enable the creation of more complex AI workflows.” FDA employees will have the option to use agentic AI, according to the agency. FDA reported that more than 70% of employees chose to use AI tool Elsa when it was launched in May. The new tool will include “built-in guidelines — including human oversight —to ensure reliable outcomes.” It includes high-security measures to ensure FDA data is safe.

FDA Commissioner Marty Makary, M.D., M.P.H. expressed the agency’s goal of providing its employees with high-quality tools in a press release. “We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators.” 

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

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