Good Machine Learning Practice for Medical Device Development: Guiding Principles from the FDA

October 27, 2021 — 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 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.

Read the Guiding Principles.