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.
Recommended Actions
- Create standardized templates for test report summaries and complete test reports following the guidance format
- 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
- Establish a review process to verify all required elements are included before submission
- Develop a tracking system to manage test reports and their locations within submissions
- Create a checklist to ensure consistency between test report summaries and complete test reports
- Implement a process to justify any testing not performed on final, finished devices
- Establish procedures for documenting and justifying protocol deviations
- 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
- Pass/fail criteria should be pre-defined with clinical/scientific/engineering justification
- Results should support overall submission (e.g., substantial equivalence for 510(k))
- Discussion/conclusions should be provided for all test results
- When using FDA-recognized standards, deviations should be documented
Relevant Guidances
- Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- De Novo Classification Process for Novel Medical Devices Without Predicates
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
Related references and norms
- No specific norms or standards are mentioned in the guidance
Original guidance
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