FDA GMLP Principles
FDA/Health Canada/MHRA Good Machine Learning Practice Guiding Principles
United States · FDA/HC/MHRA GMLP Guiding Principles (Oct. 27, 2021)
- Status
- In effect
- Took effect
- October 27, 2021
- Applies to
- Manufacturers of ML medical devices
- Enforced by
- FDA / CDRH (via existing FDCA authorities)
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.
Who is protected: Patients whose care involves ML medical devices
Legal 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.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Strength | Moderate |
| Enacted | October 27, 2021 |
| Citation | FDA/HC/MHRA GMLP Guiding Principles (Oct. 27, 2021) |
| Private right of action | No, agency enforcement only |
| Penalties | FDCA enforcement |
| Topics | healthcare AI · automated decision-making |
| Agency page | Good Machine Learning Practice for Medical Device Development — FDA |
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