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Validation Data Requirements for Reprocessed Single-Use Medical Devices

This guidance describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act for reprocessed single-use medical devices (SUDs) in 510(k) submissions. It provides guidance to industry and FDA staff on submission and review procedures for validation data in 510(k)s for reprocessed SUDs.

  1. Develop comprehensive reprocessing procedure documentation from point of use through release
  2. Establish maximum number of reprocessing cycles and validate performance through that number
  3. Perform risk analysis identifying all potential hazards
  4. Validate cleaning process including agent characterization, process parameters, and endpoints
  5. Validate sterilization process per ISO 14937
  6. Conduct functional performance testing after maximum reprocessing cycles
  7. Document procedures for tracking number of reprocessing cycles
  8. Establish procedures for assessing impact of OEM device changes
  9. Maintain complete validation documentation including protocols and reports
  10. Consider using master files for common validation data across multiple devices

Key Considerations

Non-clinical testing

  • Validation data must include cleaning, sterilization, and functional performance data demonstrating substantial equivalence to predicate device after maximum number of reprocessing cycles
  • Testing should be performed on worst-case basis after maximum intended reprocessing cycles
  • Simulated use between reprocessing cycles should be performed
  • Device must continue to meet performance specifications after maximum cycles

Labelling

  • Must specify maximum number of times device can be reprocessed
  • Must include procedures for product release and criteria for conformance
  • Must include full description of final packaging materials, configuration and shelf life

Biocompatibility

  • Devices contacting blood must be assessed for residual pyrogens after sterilization
  • Biological safety after exposure to cleaning agents must be demonstrated
  • Limits for process residuals must be documented

Safety

  • Risk analysis required identifying hazards from product and processes
  • Safety of cleaning agents under conditions of use must be documented
  • Toxicological assessment of cleaning agents required

Other considerations

  • ISO 14937: Sterilization of medical devices – General requirements for characterization of a sterilizing agent and development, validation and routine control of sterilization process
  • ISO 14971: Medical devices - Application of risk management to medical devices

Original guidance

  • Validation Data Requirements for Reprocessed Single-Use Medical Devices
  • HTML / PDF
  • Issue date: 2004-06-02
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), User Fees
  • ReguVirta summary file ID: ab3f93a7adb73f068d926282c118e274
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