FDA Starts A Discussion About How To Regulate Artificial Intelligence / Machine Learning Software As A Medical Device

By Jeffrey K. Shapiro — A cutting-edge aspect of digital health is software as a medical device (SaMD) that uses artificial intelligence and machine learning to improve its performance based on real world use and experience.  Until earlier this week, FDA has said very little about how to handle the challenge of regulating software for diagnosing or treating patient that learns and adapts in the field.  That changed when the FDA Commissioner announced the release of a 20-page discussion paper outlining a potential framework for regulation. The press release itself is relatively long and detailed, but the key elements of the framework are in the discussion paper.  It is intended to elicit comments and feedback from interested parties.  FDA even includes 18 focus questions, similar to what industry typically uses in presubmission packages for FDA. Section I of the discussion paper provides discusses traditional medical device regulation and the challenged…

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