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# Non-Clinical Bench Performance Content Guidance
- URL: https://www.fdaweb.com/non-clinical-bench-performance-content-guidance/
- Published: 2019-04-25T12:00:00.000Z
- Updated: 2026-09-15T01:22:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143961

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 reports for non-clinical bench performance testing provided in a premarket submission such as a PMA, HDE, 510(k), IDE, or de novo request. For purposes of the [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM606051.pdf?ref=fdaweb.com), non-clinical bench performance testing is defined as performance testing, performed by either a device manufacturer or third-party testing facility, that encompasses all bench testing and will be dependent upon the specifics of the actual device or device type.