Question · GMLP
What are the 10 Good Machine Learning Practice (GMLP) principles?
Ten guiding principles issued by the FDA, Health Canada and the UK MHRA in October 2021 for developing safe, effective machine-learning medical devices across the total product lifecycle.
01 / The answer
The short answer
The 10 principles, published by FDA, Health Canada and the UK MHRA in October 2021, are: multidisciplinary expertise across the product life cycle; good software engineering and security practices; clinical study participants and data sets representative of the intended patients; training data independent of test sets; reference datasets based on best available methods; model design tailored to the data and intended use; focus on human-AI team performance; testing under clinically relevant conditions; clear, essential information for users; and monitoring deployed models while managing retraining risks. They are principles, not a checklist. IMDRF issued a near-identical final version in January 2025.
02 / The rule
What GMLP requires
Ten guiding principles issued by the FDA, Health Canada and the UK MHRA in October 2021 for developing safe, effective machine-learning medical devices across the total product lifecycle. IMDRF finalized a near-identical international version in January 2025, and FDA people reviewing it use the same concepts when assessing AI-enabled device submissions.
- 01Use multidisciplinary expertise throughout the total product lifecycle and follow good software engineering and security practices.
- 02Use clinical study participants and data sets representative of the intended patient population.
- 03Keep training data sets independent of test sets, and base reference datasets on best available methods.
- 04Tailor model design to the available data and intended use, and evaluate performance of the human-AI team.
03 / Records
Records to keep
- 01Dataset documentation showing representativeness and train/test separation
- 02Reference standard (ground truth) method and rationale
- 03Clinical performance testing report under intended-use conditions
- 04Post-market performance monitoring plan and retraining change records
Optional evidence · where Planisphere fits
Keep a record anyone can check
When your team meets a duty, Planisphere can seal the event it reports as a receipt.
A disclosure shown, a review signed, a model change approved: the event your system reports.
The event becomes a sealed receipt, dated and attributed to whoever is signed in.
Paste the receipt into Verify. No account or key.
A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.
SOURCES
Go back to the source
Medicines and Healthcare products Regulatory Agency (GOV.UK)
U.S. Food and Drug Administration
International Medical Device Regulators Forum
Regulatory Affairs Professionals Society
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Related: GMLP: the full guide