Per the notice below, the United States Food and Drug Administration (FDA) has issued guidance on machine learning-enabled medical/dental devices.

Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles

Today, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles.

For a machine learning-enabled medical device, effective transparency ensures that information that could impact patient risks and outcomes is communicated to all the people who could be interacting with the medical device, including health care providers, payors, and others, to help make informed decisions.  The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles build upon the Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles and the Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles, both published jointly by the FDA, Health Canada, and MHRA.  Transparency across health care is an international priority and the FDA will continue to collaborate with international partners in this area.

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