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    Good Machine Learning Practice

    Guiding principles for the development of AI/ML-enabled medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Good Machine Learning Practice (GMLP) describes guiding principles - jointly issued by FDA, Health Canada, and the UK MHRA - for developing AI/ML-enabled medical devices that are safe, effective, and high-quality.

    What this means in practice

    GMLP principles inform FDA review expectations, including data management, model validation, and human-AI team performance.

    Cross-references

    Governs

    Things this term applies rules or requirements to.

    Contains

    Sub-elements or required artefacts of this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    1. 1
      GMLP Guiding Principles
      Verified
      FDAfda.gov
    2. 2
      FDA - Software as a Medical Device (SaMD)
      Verified
      FDAfda.gov
    3. 3
      FDA - AI/ML-Enabled Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.