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    Interoperability

    Ability of devices and systems to exchange and use information.

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

    Definition

    Interoperability is the ability of two or more medical devices, products, technologies, or systems to exchange and use information with consideration for safety, effectiveness, and security.

    What this means in practice

    FDA's interoperability guidance recommends defining the purpose of an electronic interface, anticipated users, risk management, validation, and labeling.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    1. 1
      FDA Interoperability Guidance
      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.