The Food and Drug Administration on Monday announced plans to offer its employees a broader set of artificial intelligence tools to use in pre-market reviews and for other purposes amid persistent concerns that the technology can behave unpredictably
The agency touts in a release that staff will now be able to use “agentic AI capabilities” to assist with “meeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance and administrative functions.” Agentic AI broadly refers to systems that can complete multi-step tasks autonomously. The announcement says that the agency is employing “guidelines — including human oversight — to ensure reliable outcomes.”
Asked for more details about these guidelines, Ben Nichols, an FDA spokesman, wrote in

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