FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions
The US Food and Drug Administration (FDA) on Friday finalized guidance on the content and format of non-clinical bench performance testing information to be included in premarket submissions for medical devices.The 12-page guidance, which FDA said was revised “as appropriate in response to the comments,” is meant for all types of device submissions (from 510(k) to de novo to PMA) and finalizes a draft guidance from May 2018.
Non-clinical bench performance testing can include tests run by the device manufacturer or a third party to evaluate mechanical and biological engineering performance (such as fatigue, wear, tensile strength, compression, burst pressure); bench tests using ex vivo, in vitro and in situ animal or human tissue; and animal carcass or human cadaveric testing.
FDA recommends test report summaries within the body of a company’s premarket submission that briefly describe and summarize: The test performed, objective, test methods, pre-defined pass/fail criteria (when applicable), a results summary, discussion/conclusions, location of the complete test report and an optional summary table.
As for the complete test reports, the guidance calls for it to be attached to the main body of the submission, such as in an appendix. “A complete test report means the entirety of the testing documentation submitted for a study, which some submitters or test labs might embody in a single document, while others might embody in multiple and separate documents.”
The complete report would include information such as the test sample size/selection, the data analysis plan and protocol deviations, among other pieces of information.
FDA said the guidance’s recommendations, which are not intended to constitute new policy, reflect what has been previously included in device-specific guidance documents and are consistent with review feedback for premarket submissions when non-clinical bench testing is provided.
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and FDA Staff