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FDA Issues Discussion Paper on Regulating AI and ML as Medical/Dental Devices

The United States Food and Drug Administration (FDA) has issued a discussion paper on the regulatory framework to use for artificial intelligence (AI) and machine learning (ML) software as medical/dental devices.  The FDA noted that it is exploring a framework that would allow for modifications to AI and ML algorithms to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical/dental device is maintained.  You can submit comments on the discussion paper to the FDA at:FDA-2019-N-1185 by June 3, 2019.  To read the FDA discussion paper on regulation of AI and ML as medical/dental devices, use the first link below.  To read the FDA  announcement and summary of its proposed regulatory framework for AI and ML as medical/dental devices, use the second link below.
https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/SoftwareasaMedicalDevice/UCM635052.pdf?utm_campaign=2019-04-02%20Discussion%20Paper%20on%20Regulating%20Artificial%20Intelligence&utm_medium=email&utm_source=Eloqua  (FDA discussion paper on regulation of AI and ML in medical/dental devices)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635083.htm?utm_campaign=040219_Statement_Statement%20on%20FDA%E2%80%99s%20steps%20toward%20a%20tailored%20review%20framework%20for%20AI%2FML&utm_medium=email&utm_source=Eloqua  (FDA announcement and summary of proposed regulatory framework for AI and ML in medical/dental devices)
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