_Regulation · Safety standard_

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

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

- **Jurisdiction:** [Global](/locations/global.md) (id: `6753d6b9-d63f-41f8-b672-4d80bdb4dd82`)
- **Kind:** `safety_standard`
- **Status (derived):** in_effect
- **Effective:** 2025-01-01

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.

## 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.


_API: GET /v1/regulations/e8228fd0-b022-468c-aec7-f5d8ac6d46b2 · sources: /v1/regulations/e8228fd0-b022-468c-aec7-f5d8ac6d46b2/sources · status: /v1/regulations/e8228fd0-b022-468c-aec7-f5d8ac6d46b2/status · canonical URL: /regulations/fda-gmlp-guiding-principles-2025_