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FDA Collaborates with Canada and UK on Guiding Principles for Machine Learning-Enabled Medical Devices
June 13, 2024
Dear International Colleague,
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 "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, payers, and others — to help make informed decisions.
The new 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.
For more information about Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles, please contact the Digital Health Center of Excellence at digitalhealth@fda.hhs.gov.
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