New FDA Guidance Regarding Bench Testing
The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports are typically not needed for Special 510(k)s and for some testing provided within Abbreviated 510(k)s. Conclusions from testing should discuss how the results support the overall submission (i.e. substantial equivalence for 510(k), reasonable assurance of safety and effectiveness for PMA). Test report summaries may be included in the executive summary of a premarket submission or as a distinct document. In test report summaries, include:
identify if the test was conducted as recommended by FDA guidance document or FDA-recognized consensus standard
Objective(s) of the test(s)
A brief description of the test methods, including sample size, device(s) tested, and any consensus standard(s) utilized
Describe the test sample (i.e. finished product vs. prototype, complete device vs. component)
Describe how the samples represent a clinically relevant worst-case scenario(s)
Pre-defined pass/fail criteria (when applicable)
Use assessment criteria for data interpretation if pass/fail criteria are not used
Provide appropriate summary for quantitative and/or qualitatively data
Highlight failed results and deviations and describe how they were resolved
As an alternative, utilize summary tables to capture the information above about performed tests while also providing written discussion of results/conclusions as needed.
Complete test reports should include all items listed above, in more detail. Additionally, the complete test result should report the data analysis plan and associated results and the data collected from the test. Data collected should be accompanied by a summary of the data and applicable statistical information. In the premarket submission, establish links to locations of the complete test reports within the summary.
We at Rook Quality Systems have updated templates to cover test protocol and report documentation. Our test report templates cover both the summary as well as in-depth results that can be easily separated in preparation of the premarket submission. For our test report template, sections 1 and 2 will satisfy the items FDA looks for in the test report summary as well as satisfying the complete test report with the document as a whole. The full text of the FDA guidance can be found here for your review.