Standards Committee presents

FDA Releases Artificial Intelligence/Machine Learning Action Plan

News And Updates

The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan

This AI/ML-Based Software as a Medical Device Action Plan builds on the Agency’s longstanding commitment to support innovative work in the regulation of medical device software and other digital health technologies. Stakeholders provided strong general support for the idea and importance of Good Machine Learning Practice (GMLP), and there was a call for FDA to encourage harmonization of the development of GMLP through consensus standards efforts and other community initiative.Given the need for GMLP, the Agency has been an active participant in numerous efforts related to their development, including standardization efforts and collaborative communities. For example, FDA maintains liaisons to the Institute of Electrical and Electronics Engineers (IEEE) P2801 Artificial Intelligence Medical Device Working Group and the International Organization for Standardization/ Joint Technical Committee 1/ SubCommittee 42 (ISO/ IEC JTC 1/SC 42) – Artificial Intelligence; and it participates in the Association for the Advancement of Medical Instrumentation (AAMI)/ British Standards Institution (BSI) Initiative on AI in medical technology. As part of this Action Plan, FDA is committing to deepening its work in these communities in order to encourage consensus outcomes that will be most useful for the development and oversight of AI/ML based technologies. Read more

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