GoKawiilFDA seeks public input on regulating generative-AI medical devices
The US Food and Drug Administration has published a discussion paper inviting feedback on how to regulate generative-AI-enabled medical devices, with submissions due by a set deadline. The move comes as thousands of studies on AI tools in clinical medicine are published yearly and more than 230 million people weekly ask chatbots health-related questions.
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The rapid clinical adoption of AI tools for diagnosis, prescribing and image interpretation has outpaced clear regulatory frameworks, leaving open questions about oversight and accountability. Researchers argue that real-world testing is essential before these systems can be trusted, suggesting the FDA's input process could shape how rigorously such devices are validated going forward.
- FDA published a discussion paper on regulating generative-AI medical devices and is seeking public feedback.
- AI tools are increasingly used in diagnostics, prescribing, and image analysis in clinical settings.
- Researchers are urged to submit comments before the stated deadline to influence future regulation.
Source: nature.com, 2026-09-29
Published there as: “AI-powered medical devices must be tested in real-world settings”
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