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.
Recommended Actions
- Submit a PCCP in any future 510(k) submission if no applicable PCCP exists
- Include in PCCP:
- Description of modifications and applicability
- Specific procedures for data re-evaluation
- Planned labeling updates
- Performance criteria verification process
- 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
- For new 510(k) submissions:
- Incorporate by reference any previously cleared PCCP
- Include reference to prior submission number
- Monitor STIC Website for breakpoint updates
- Maintain documentation of all changes and evaluations in quality system
- 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
- PCCP must be reviewed and cleared as part of 510(k) submission
- Updates must be consistent with FDA-recognized breakpoints on STIC Website
- Breakpoints must fall within drug concentration range reviewed and cleared by FDA
- Changes must be documented in manufacturer’s quality system
Relevant Guidances
- Predetermined Change Control Plans for Medical Device Modifications (Draft)
- Quality System Information Requirements for Premarket Submissions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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
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