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    Predetermined Change Control Plan

    FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.

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

    Definition

    A Predetermined Change Control Plan (PCCP) is a document, included in a marketing submission, that describes planned modifications to an AI/ML-enabled device, the methods used to develop, validate, and implement those modifications, and the impact on the device.

    What this means in practice

    PCCPs let manufacturers update AI/ML models within an authorized envelope without a new submission, while preserving safety and effectiveness controls.

    Use cases

    1 scenario
    1

    Continuous learning chest-X-ray triage SaMD

    ML & RA team

    The sponsor includes a Predetermined Change Control Plan in the 510(k): allowed modifications (retraining cadence, new sites), the protocol (data governance, performance thresholds), and impact assessment.

    OutcomeAfter clearance, the team retrains quarterly under the PCCP without filing a new submission for each update.

    Cross-references

    See also

    Closely related context worth reading.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2IMDRF·1
    1. 1
      FDA PCCP Guidance
      Verified
      FDAfda.gov
    2. 2
      FDA - AI/ML-Enabled Medical Devices
      Verified
      FDAfda.gov
    3. 3
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org

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