FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles
[in effect]Global · safety standard · safety standard
Jurisdiction
Global
Classification
safety standard
Status
in effect
Effective Date
Jan 1, 2025
Primary Sources
1 audited
Statutory Scope & Summary
FDA, Health Canada, and UK MHRA finalized 10 Good Machine Learning Practice (GMLP) guiding principles for medical device AI/ML development, covering data quality, bias mitigation, transparency, human-AI teaming, and post-market monitoring. IMDRF released final GMLP principles in January 2025.
Covered Sectors & Application Domains
Regulatory Analysis & Inquiries
6 entriesWhat does FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles cover?
FDA, Health Canada, and UK MHRA finalized 10 Good Machine Learning Practice (GMLP) guiding principles for medical device AI/ML development, covering data quality, bias mitigation, transparency, human-AI teaming, and post-market monitoring. IMDRF released final GMLP principles in January 2025.
Where does FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles apply?
FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles is recorded as a safety_standard applying in Global on the DEPLOY registry.
When did FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles take effect?
FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles is recorded as effective January 1, 2025 on the DEPLOY registry.
Is FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles still in effect?
FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles apply to?
FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles is recorded as applying to surgical, biometric, wearable on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles?
8 robot models on the DEPLOY registry match the form-factor scope of FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles: AI Pin, ANOVO, AirGo Vision, Amazfit (Balance / Active / T-Rex / Helio) and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Primary Sources & Legal Instruments
1 document- https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principlesOfficial Source
https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles