Good Machine Learning Practice for Medical Device Development: Guiding Principles (FDA, Health Canada, UK MHRA)

Summary

Ten guiding principles for good machine learning practice (GMLP) in developing medical devices that use AI/ML, released in October 2021 jointly by the FDA, Health Canada and the UK Medicines and Healthcare products Regulatory Agency. They are non-binding principles intended to promote safe, effective, high-quality ML-enabled devices across the product life cycle. In January 2025 the International Medical Device Regulators Forum (IMDRF) issued a final document identifying 10 GMLP guiding principles that builds on the 2021 set; FDA's GMLP page now presents the IMDRF document.

Key dates

1. October 2021Takes effect
2. October 2021Issued
3. October 16, 2026Checked against sources

Developments are added when the record is reviewed. Next review: October 16, 2027.

Evidence

Each passage is quoted from its source. The quoted passages are re-checked against the live pages every month.

1. The final document from IMDRF builds on the guiding principles released in October 2021 by the U.S. Food and Drug Administration, Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency.

   Supports: October 2021; joint issuers

   In January 2025, the International Medical Device Regulators Forum (IMDRF) released a final document that identifies 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP).

   Supports: IMDRF January 2025

   Good Machine Learning Practice for Medical Device Development: Guiding Principles U.S. Food and Drug Administration Primary source