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    AI/ML-Enabled Medical Device

    Medical device that uses artificial intelligence or machine learning to perform its intended use.

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

    Definition

    An AI/ML-enabled device incorporates models that learn patterns from data to provide diagnostic, predictive, monitoring, or therapeutic functions. FDA maintains a public list of AI/ML-enabled devices that have been authorized.

    What this means in practice

    Most authorized AI devices today are 'locked' - the model weights do not change post-deployment. Adaptive systems require a Predetermined Change Control Plan (PCCP) to enable continued learning while maintaining oversight.

    Cross-references

    Governed by

    Regulations or standards this term must comply with.

    Uses

    Concepts or artefacts this term builds on.

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2MDCG·1
    1. 1
      FDA AI/ML-Enabled Device List
      Verified
      FDAfda.gov
    2. 2
      MDCG Software Guidance
      Verified
      MDCGhealth.ec.europa.eu
    3. 3
      FDA - Software as a Medical Device (SaMD)
      Verified
      FDAfda.gov

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