- FDA issued guidance Thursday with its recommendations for information about non-clinical bench performance testing for medical devices that manufacturers should include in premarket submissions.
- The guidance outlines what to include in test report summaries, test protocols and complete test reports.
- The information is intended to be used in conjunction with other FDA guidance such as device-specific documents and specific test reporting recommendations in FDA-recognized standards.
Non-clinical bench performance testing can be completed by either a device manufacturer or third party testing facility and depends on the actual device or device type. It covers mechanical and biological engineering performance such as fatigue, wear, tensile strength, compression and burst pressure; bench tests using ex vivo, in vitro, and in situ animal or human tissue; and animal carcass or human cadaver testing, FDA said.
The testing excludes biocompatibility evaluation, reprocessing or sterilization validation, human factors, software verification and validation, and computational modeling. Test reports for clinical studies, animal studies and studies evaluating the performance characteristics of in vitro diagnostic devices are also excluded.
FDA is recommending that premarket submissions include test report summaries and complete test reports. Manufacturers are advised to either embed a summary in an executive summary section of the premarket submission or provide it as a separate document. Complete test reports should be separate attachments. Test protocols can be separate attachments or included as part of a complete test report.
Complete test reports are typically not needed for special 510(k)s and for some testing provided within abbreviated 510(k)s, FDA said.
A premarket submission should describe how the non-clinical bench performance test results support the overall submission, the agency said.
Conclusions from the testing should cover how the testing demonstrates substantial equivalence of the device to the primary predicate device for a 510(k) or reasonable assurance of safety and effectiveness for a premarket approval application or de novo request. The information can be provided in the test report summary or other location in the premarket submission, and the information should be referenced appropriately for ease of identification within the submission.
Test report summaries should include the tests performed, test objectives and methods, pre-defined pass/fail criteria, results summary, discussion and conclusions, and location of the complete test report. A summary table is optional.
Complete test reports should have the test performed, objective, description of test methods, pass/fail criteria, data analysis plan, test results, and discussion and conclusions, per the guidance documents.
Test protocols can be provided in the premarket submission within the complete test report or as a separate document. They typically consist of the methods that were used to conduct the testing, the objective, pre-specified acceptance criteria and data analysis plan, FDA said.