FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

Today, the U.S. Food and Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Good Machine Learning Practice for Medical Device Development: Guiding Principles” to identify a set of ten guiding principles that are important to be included in the development of Good Machine Learning Practice (GMLP). Good Machine Learning Practice is intended to advance high quality artificial intelligence/machine learning enabled medical device development.

These ten principles are intended to identify areas where alignment in efforts related to research, building resources and tools, regulatory policies, regulatory guidelines, international harmonization and consensus standards could be developed by the International Medical Device Regulators Forum (IMDRF), international standards organizations and other collaborative bodies to advance the maturation of GMLP.

The FDA envisions that these guiding principles could be used to either specifically tailor practices applicable to health care, create new practices for health care or adopt from practices that have been proven in other domains.

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