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Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions

This guidance outlines the recommended content and format for non-clinical bench performance testing information in premarket submissions (PMA, HDE, 510(k), IDE, De Novo). It covers mechanical and biological engineering performance testing, ex vivo/in vitro tests, and animal/human cadaveric testing. The guidance excludes biocompatibility, sterilization validation, human factors, software V&V, computational modeling, clinical studies, and IVD performance testing.

  1. Create standardized templates for test report summaries and complete test reports following the guidance format
  2. Implement a process to ensure all non-clinical bench testing documentation includes:
    • Clear test objectives
    • Detailed test methods
    • Sample size justification
    • Pre-defined acceptance criteria
    • Complete data analysis
    • Protocol deviation documentation
    • Clear conclusions
  3. Establish a review process to verify all required elements are included before submission
  4. Develop a tracking system to manage test reports and their locations within submissions
  5. Create a checklist to ensure consistency between test report summaries and complete test reports
  6. Implement a process to justify any testing not performed on final, finished devices
  7. Establish procedures for documenting and justifying protocol deviations
  8. Create a system to ensure proper documentation when using FDA-recognized standards

Key Considerations

Non-clinical testing

  • Test report summaries should be included in all submissions
  • Complete test reports should be provided as separate attachments
  • Test protocols can be provided separately or as part of complete test reports
  • All documents should be clear, legible and in English
  • Testing should be performed on final, finished devices when possible
  • Sample size selection should be scientifically justified
  • Multiple manufacturing lots should be tested when appropriate
  • Test methods should be described in sufficient detail
  • Data analysis plan should be included
  • All test results including outliers should be reported
  • Protocol deviations should be documented and explained

Other considerations

  • No specific norms or standards are mentioned in the guidance

Original guidance

  • Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
  • HTML / PDF
  • Issue date: 2019-12-20
  • Last changed date: 2020-10-20
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 1e3ea223620774419987f4c6f1642472
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