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Good Machine Learning Practice for Medical Device Development: Guiding Principles
Today, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Good Machine Learning Practice for Medical Device Development: Guiding Principles.
The joint effort identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP) to help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
These 10 guiding principles are intended to lay the foundation for Good Machine Learning Practice (GMLP) that addresses the unique nature of these products and will help cultivate future growth in this rapidly progressing field. The 10 guiding principles also identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations, and other collaborative bodies could work to advance GMLP. The FDA’s Digital Health Center of Excellence continues to work with international regulatory partners and the broader community to align efforts to advance digital health.
About the Digital Health Center of Excellence
Launched in September 2020 and located in the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence is committed to strategically advance science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. The goal of the Digital Health Center of Excellence is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
Questions?
If you have questions about artificial intelligence and machine learning, email digitalhealth@fda.hhs.gov.
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