FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

First publishedAug 18, 14:10 UTC

Last updatedAug 18, 17:10 UTC · 3m ago

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FDA10FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical DevicesAug 18, 14:10 UTCOpen ↗

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Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to the regulation of GenAI-enabled medical devices. This effort aligns with one of the Trump Administration’s key priorities to harness AI to accelerate the delivery of innovative medical products to market. “Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.” The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health, is leading this discussion paper which supports the FDA’s Public Health Pillar on Innovation and Global Leadership.

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  FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

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