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Predetermined Change Control Plans for Antimicrobial Susceptibility Test Systems: Updating Breakpoints in Device Labeling

This guidance is limited to antimicrobial susceptibility test (AST) system devices classified under specific regulations (21 CFR 866.1640, 866.1645, 866.1650) and focuses on recommendations for Predetermined Change Control Plans (PCCPs) to update AST system device labeling with new breakpoints. It excludes antimicrobial susceptibility test discs and other modifications unrelated to breakpoint updates.

  1. Submit a PCCP in any future 510(k) submission if no applicable PCCP exists
  2. Include in PCCP:
    • Description of modifications and applicability
    • Specific procedures for data re-evaluation
    • Planned labeling updates
    • Performance criteria verification process
  3. For legacy devices:
    • Evaluate if existing cleared PCCP can be utilized
    • Document changes and protocol use in quality system
    • Submit updated labeling to FDA’s designated inbox
  4. For new 510(k) submissions:
    • Incorporate by reference any previously cleared PCCP
    • Include reference to prior submission number
  5. Monitor STIC Website for breakpoint updates
  6. Maintain documentation of all changes and evaluations in quality system
  7. Contact FDA for additional guidance if needed through pre-submission process

Key Considerations

Clinical testing

  • Re-evaluation of previously collected clinical data must demonstrate unchanged device performance with updated breakpoints
  • Must meet prespecified performance criteria for category agreement, essential agreement, and error rates

Non-clinical testing

  • Sufficient number of resistant isolates required based on microbiology activity spectrum and MIC distribution data
  • Performance evaluation with updated breakpoints must be maintained compared to most recently cleared device

Labelling

  • Must update device labeling to incorporate new breakpoint information
  • Must update performance characteristics or limitations based on evaluation
  • Updated labeling should be sent to FDA’s designated email inbox

Safety

  • Changes must not reveal new risks or significantly modify existing risks
  • Must document changes in accordance with quality system requirements

Other considerations

  • 21 CFR 866.1640: Antimicrobial susceptibility test system
  • 21 CFR 866.1645: Automated antimicrobial susceptibility test system
  • 21 CFR 866.1650: Blood culture identification and susceptibility test system
  • 21 CFR Part 820: Quality System Regulation

Original guidance

  • Predetermined Change Control Plans for Antimicrobial Susceptibility Test Systems: Updating Breakpoints in Device Labeling
  • HTML / PDF
  • Issue date: 2023-09-29
  • Last changed date: 2023-09-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Antimicrobial Resistance
  • ReguVirta summary file ID: 606f045ce5facf479fb8b4e3b4c64788
This post is licensed under CC BY 4.0 by the author.