Guidance

Good Machine Learning Practice for Medical Device Development: Guiding Principles

Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).

Documents

Good Machine Learning Practice for Medical Device Development: Guiding Principles

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The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).

Published 27 October 2021