Lexology October 6, 2025
The U.S. Food and Drug Administration (FDA) is offering an opportunity for stakeholders to provide feedback to “advance a broader discussion among the AI healthcare ecosystem.” Specifically, the FDA has issued a Request for Public Comment to gather insights on evaluating the real-world performance of AI-enabled medical devices, including generative AI technologies.
This initiative, detailed in Docket No. FDA-2025-N-4203, aims to ensure these devices remain safe and effective post-deployment by further evaluating challenges like data drift that may impact the accuracy and reliability of predictive models. Comments are due by December 1, 2025.
The FDA is seeking input from industry stakeholders on practical approaches to monitor and assess AI-enabled medical devices through a series of targeted questions.
Key topics include:
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