FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently released a document outlining “guiding principles” essential to the development of medical devices using artificial intelligence (AI) and machine learning (ML).

The document, “Good Machine Learning Practices for Medical Device Development: Guiding Principles,” was published in October in a joint effort by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The document outlines 10 guiding principles that the agencies say provide a sound foundation for the future development of advanced medical devices, while also enabling regulators, standards organizations, and industry to work collaboratively to advance the deployment of safe and effective AI- and ML-based devices.

Read the complete text of the Guiding Principles jointly issued by the U.S. FDA, Health Canada, and the MHRA. Interested parties can submit comments on the document through www.regulations.gov (reference Docket FDA-2019-N-1185).

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