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Sterilization of Convenience Kits: Component Compatibility and Validation Requirements

This guidance addresses concerns about finished device components that are assembled into clinical or surgical convenience kits and then sterilized. It focuses on ensuring that the sterilization process does not adversely affect the finished components in these kits.

  1. Assess and document the impact of sterilization process on kit components
  2. Measure and evaluate sterilant residuals
  3. Develop and validate appropriate labeling including storage instructions and expiration dating
  4. Determine regulatory pathway requirements (510(k) or PMA)
  5. Implement quality system requirements including:
    • Manufacturing controls
    • Labeling controls
    • Post-market surveillance
    • Adverse event reporting
    • Corrections and removals procedures
  6. Maintain documentation of all validation studies and controls
  7. Ensure shortest component expiration date is used for overall kit
  8. Verify package integrity post-sterilization
  9. Consult with device component manufacturers regarding sterilization compatibility

Key Considerations

Non-clinical testing

  • Validate stability data to support expiration dating
  • Conduct process validation studies for devices
  • Evaluate effects of storage conditions (e.g., one year at room temperature at 30 degrees centigrade)

Labelling

  • Provide instructions for appropriate storage conditions
  • Include expiration date supported by stability data
  • Ensure expiration date is not longer than the shortest expiration date of any component
  • Validate storage instructions

Safety

  • Evaluate effects of sterilization process on material degradation
  • Assess impact of sterilization on form, fit, and function of device components
  • Verify package integrity remains intact after sterilization
  • Determine sterilant residuals

Other considerations

  • ICH Q1A: Stability Testing of New Substances and Products
  • 21 CFR Part 820: Quality System Regulation
  • 21 CFR Part 803: Medical Device Reporting
  • 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals

Original guidance

  • Sterilization of Convenience Kits: Component Compatibility and Validation Requirements
  • HTML / PDF
  • Issue date: 2002-01-07
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket
  • ReguVirta summary file ID: c858061f7138a4dcbf901e1ed643ca4e
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