Reference device

A reference device can help show how a new technological characteristic should be tested, but it cannot be the basis for substantial equivalence. FDA expects a submission to keep the two roles clearly apart.

A legally marketed device that is intended to provide scientific and/or technical information (e.g., test methodology) to help address the safety and effectiveness of a new technological characteristic. Reference devices are not predicate devices and may only be used after Decision Point 4 on the 510(k) Decision-Making Flowchart.

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