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# Non-Clinical Bench Performance Guidance Out
- URL: https://www.fdaweb.com/non-clinical-bench-performance-guidance-out/
- Published: 2020-01-02T12:00:00.000Z
- Updated: 2026-09-14T15:56:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145743

FDA has published a guidance, *Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions*, to describe relevant information that should be included in test report summaries, test protocols, and complete test PMA applications, HDE applications, 510(k) submissions, IDE applications, and *De Novo* requests. For purposes of the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-non-clinical-bench-performance-testing-information-premarket?ref=fdaweb.com), non-clinical bench performance testing is defined as performance testing, performed by either a device manufacturer or a third party testing facility, which encompasses all bench testing and will be dependent upon the specifics of the actual device or device type.

Non-clinical bench performance testing includes, but is not limited to, 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 cadaveric testing, FDA says. It excludes biocompatibility evaluation, reprocessing or sterilization validation, human factors, software verification and validation, and computational modeling, because relevant information on these assessments is detailed in associated guidances. Test reports for clinical studies, animal studies, and studies evaluating the performance characteristics of *in vitro* diagnostic devices are also excluded from the document’s scope.

The agency says the information in the guidance is intended to help ensure that clear and consistent information is provided in premarket submissions containing non-clinical bench performance testing.