FDA/Health Canada/MHRA Good Machine Learning Practice Guiding Principles
United States · FDA/HC/MHRA GMLP Guiding Principles (Oct. 27, 2021)
Joint guiding principles by FDA, Health Canada, and the UK MHRA on safe development of ML-enabled medical devices. Updated by FDA's 2024 Transparency Guiding Principles.
Technical detail
10 GMLP guiding principles cover good software engineering, representative datasets, independence of training/test data, model-design tailored to data and clinical use, focus on the performance of the human-AI team, clinically meaningful test performance, training data quality, transparency, monitoring of deployed performance, and clear cybersecurity practices.
Who is protected: Patients whose care involves ML medical devices
Who must comply: Manufacturers of ML medical devices
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Status | In effect |
| Protection strength | Moderate protection |
| Effective date | 2021-10-27 |
| Enacted | 2021-10-27 |
| Citation | FDA/HC/MHRA GMLP Guiding Principles (Oct. 27, 2021) |
| Enforced by | FDA / CDRH (via existing FDCA authorities) |
| Private right of action | No — agency enforcement only |
| Penalties | FDCA enforcement |
| Topics | healthcare AI · automated decision-making |
| Last verified | 2026-06-16 |
| Official source | Good Machine Learning Practice for Medical Device Development — FDA ↗ |
More AI rules in United States
- FTC Act Section 5 (unfair/deceptive AI) · In effect
- TAKE IT DOWN Act · In effect
- FCRA (AI in credit & background checks) · In effect
- ECOA / Regulation B (AI credit discrimination) · In effect
- Title VII / ADA (AI hiring) · In effect
- COPPA + 2025 Rule (childrens data) · In effect
Related healthcare AI rules elsewhere
- Colorado AI Act (repealed) · Repealed / replaced
- SB 26-189 (Colorado ADMT Law) · Enacted (not yet in effect)
- AI Companion Safeguards Law · In effect
- Utah AI Policy Act · In effect
- HB 452 (Mental Health Chatbots) · In effect
- My Health My Data Act · In effect
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