DEPLOYDatabase

Regulation · Safety standard

FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles

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.

Jurisdiction: Global · Effective 2025-01-01

Machine-readable surfaces

Sources (1)

  1. https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles · 2025-01-01

Status history

  • In effect · 2025-01-01 · agent-recon

    Initial ingestion

Common questions

What 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.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles.

Canonical ID e8228fd0-b022-468c-aec7-f5d8ac6d46b2