FDA announces action plan for AI/ML software as a medical device

In April 2019, the Food and Drug Administration (FDA) published a proposed regulatory framework for evaluating modifications for artificial intelligence/machine learning (AI/ML) software as a medical device (SaMD). AI/ML technologies in SaMD present unique issues, because the technology is intended to learn from real-world feedback and incorporate improvements into the SaMD algorithms. Since publishing the proposed framework, the FDA utilized workshops, publications and other means to obtain stakeholder feedback from device manufacturers and the public. The recently published action plan describes the agency’s intended actions incorporating this feedback.

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FDA Considers Adapting Regulatory Approval Processes for Artificial Intelligence/Machine Learning

Over the last several years, the Food & Drug Administration (FDA) has been grappling with how to tailor its regulatory approval pathways for Software as a Medical Device (SaMD). SaMD is defined as software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device. The FDA utilizes different pathways for manufacturers prior to distribution of the SaMD, depending on risk. The introduction of artificial intelligence (AI) and machine learning (ML) technologies further complicates this evaluation. The FDA published a discussion paper in April 2019 describing a proposed regulatory framework for modifications to AI/ML software.

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