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    Predetermined Maintenance vs PCCP

    Distinction between routine maintenance changes (cybersecurity patches, minor fixes) and PCCP-controlled algorithm changes.

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

    Definition

    Not every software change to an AI/ML device requires a PCCP - cybersecurity patches, bug fixes, and infrastructure updates often fall under standard software maintenance. PCCPs specifically govern pre-specified algorithm modifications.

    What this means in practice

    Drawing the boundary clearly in the submission and SOPs prevents unnecessary submissions and confusion at audit time.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1IMDRF·1MDCG·1
    1. 1
      FDA PCCP Guidance
      Verified
      FDAfda.gov
    2. 2
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org
    3. 3
      MDCG Software Guidance
      Verified
      MDCGhealth.ec.europa.eu

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