{"id":"e8228fd0-b022-468c-aec7-f5d8ac6d46b2","slug":"fda-gmlp-guiding-principles-2025","kind":"safety_standard","headline":"FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles","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.","locationId":"6753d6b9-d63f-41f8-b672-4d80bdb4dd82","effectiveAt":"2025-01-01T00:00:00.000Z","expiresAt":null,"reviewStatus":"unreviewed","formFactors":["surgical","biometric","wearable"],"jurisdiction":"Global","complianceDeadline":null,"enforcementEvents":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"createdAt":"2026-08-09T14:31:36.779Z","updatedAt":"2026-08-09T14:31:36.779Z","location":{"id":"6753d6b9-d63f-41f8-b672-4d80bdb4dd82","name":"Global","slug":"global","kind":"site","parentLocationId":null,"region":null,"lat":null,"lng":null,"reviewStatus":"reviewed","aliases":[],"collisionRisk":"high","reviewNote":"Ungeocodable: non-geographic or multi-region location","createdAt":"2026-06-08T01:03:25.017Z","updatedAt":"2026-07-15T14:55:14.618Z"},"derived":{"status":"in_effect"},"sources":[{"id":"b1a0a60c-114e-41ab-9c2a-e66df4bdef0a","regulationId":"e8228fd0-b022-468c-aec7-f5d8ac6d46b2","url":"https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles","label":null,"publishedAt":"2025-01-01T00:00:00.000Z","notes":null,"title":"Good Machine Learning Practice for Medical Device Development: Guiding Principles","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T14:31:36.779Z","updatedAt":"2026-08-09T14:31:36.779Z"}],"statusEvents":[{"id":"bfad3e80-aad7-4e1d-9f47-90eb0de82274","regulationId":"e8228fd0-b022-468c-aec7-f5d8ac6d46b2","status":"in_effect","reason":"Initial ingestion","source":"agent-recon","effectiveAt":"2025-01-01T00:00:00.000Z","createdAt":"2026-08-09T14:31:36.779Z"}],"jsonLd":{"@context":"https://schema.org","@type":"Legislation","@id":"https://registry.deploy.report/regulations/fda-gmlp-guiding-principles-2025","url":"https://registry.deploy.report/regulations/fda-gmlp-guiding-principles-2025","name":"FDA/Health Canada/MHRA Good Machine Learning Practice (GMLP) Guiding Principles","description":"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.","identifier":"e8228fd0-b022-468c-aec7-f5d8ac6d46b2","legislationDate":"2025-01-01T00:00:00.000Z","legislationApplies":{"@type":"Place","name":"Global"},"publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-fda-database"]}}}