{"id":419972,"date":"2025-12-02T17:32:38","date_gmt":"2025-12-02T17:32:38","guid":{"rendered":"https:\/\/www.europesays.com\/us\/419972\/"},"modified":"2025-12-02T17:32:38","modified_gmt":"2025-12-02T17:32:38","slug":"fda-offers-staff-agentic-ai-to-support-pre-market-reviews-other-tasks","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/419972\/","title":{"rendered":"FDA offers staff \u201cagentic AI\u201d to support pre-market reviews, other tasks"},"content":{"rendered":"

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech\u2019s promise. He\u2019s also the co-author of the free, twice weekly STAT Health Tech newsletter<\/a>. You can reach Mario on Signal at mariojoze.13.<\/p>\n

The Food and Drug Administration on Monday announced plans to offer its employees a broader set of artificial intelligence tools to use in premarket reviews and for other purposes amid persistent concerns that the technology can behave unpredictably.<\/p>\n

The agency touts in a release that staff will now be able to use \u201cagentic AI capabilities\u201d to assist with \u201cmeeting management, pre-market reviews, review validation, post-market surveillance, inspections and compliance and administrative functions.\u201d Agentic AI broadly refers to systems that can complete multistep tasks autonomously. The announcement<\/a> says that the agency is employing \u201cguidelines \u2014 including human oversight \u2014 to ensure reliable outcomes.\u201d\u00a0<\/p>\n

Asked for more details about these guidelines, Ben Nichols, an FDA spokesperson, wrote in an email that the \u201cagentic AI tools are exploratory\u201d and that the AI does not make regulatory decisions or replace human judgement. \u201cAll outputs from AI are reviewed and validated\u201d by FDA staff \u201cbefore being incorporated into any official regulatory action, ensuring that the AI remains a support tool rather than a decision maker,\u201d he wrote. (The FDA\u2019s drug center alone<\/a> has lost over 1,000 staff this year through reductions in force and voluntary departures.)<\/p>\n

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