Performance data

Most 510(k)s rely on bench, biocompatibility, software and animal testing, and clinical data are needed only when other data cannot answer the questions raised by differences from the predicate. FDA's device-specific guidances often state which performance data it expects.

Performance data can be any data, including non-clinical (e.g., data from engineering testing, such as fatigue, wear, corrosion, etc., biocompatibility, functional animal studies, cadaver, etc.) and/or clinical, that are provided to support the substantial equivalence of a device that is intended to be marketed.

FDA guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 2014), Appendix D, Glossary of Significant Terminology