EMERGO SUMMARY OF KEY POINTS:

• US FDA issues recommendations for premarket test submissions regarding specific descriptions, inclusions, format, and report types.
• Recommendations include structured outlines that encapsulate test motives that are to be included with each required Summary Report submission.
• Specific FDA recommendations cover content and organization of complete Test Reports from overall description through conclusion.

For non-clinical, pre-market bench performance test submissions, the US Food and Drug Administration has issued guidelines for the required structure and content for each submission. This applies to Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Investigational Device Exemption (IDE) applications, premarket notification (510(k)) submissions, and De Novo requests.

The recommendations for the performance test reports are based on bench tests of actual non-clinical devices or device types.  Some of these tests include mechanical and biological engineering performance, bench tests using animal or human tissue, and animal or human cadaveric testing. These tests DO NOT include: biocompatibility evaluation, sterilization, animal in vivo evaluation, test reports for clinical studies, animal studies, and studies evaluating performance characteristics for IVD devices.

Required information on test reports

For a draft to be accepted for FDA review, a complete Test Report must be submitted in the recommended format with pertinent content.

*Note: For Special 510(k)s or for tests requiring a Declaration of Conformity to an FDA-   recognized consensus standard, a complete Test Report is not required. For more information, please refer to Recognition and Use of Consensus Standards.  

While not required, the FDA also recommends that these submissions include a Summary Report to provide an overview of the conducted test.

Test reports

Test Reports for non-clinical bench performance require an objective description of methods, pre-defined pass/fail criteria, results, and a conclusion to be considered complete.

• Test performed
• Objective of the test
• Description of test methods/procedures
  
  • Test sample information
  • Test sample size/selection
  • Test protocol
• Pre-defined pass/fail criteria
• Test results
  
  • Data points
  • Data analysis
  • Protocol deviations
• Discussion of the conclusions

Summary Reports

Although not required, the Summary Report is strongly recommended and will help the FDA facilitate your test review. The goal is to provide a brief summation of your test(s) while following the same structure as the aforementioned Test Reports outline.

Related US FDA medical device regulatory resources:

• US FDA consulting for medical device and IVD manufacturers
• Medical device mechanical and performance testing support