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.
(FDA discussion paper on regulation of AI and ML in medical/dental devices)
(FDA announcement and summary of proposed regulatory framework for AI and ML in medical/dental devices)