Indications for use

In a 510(k), the indications for use can differ from the predicate's as long as the intended use stays the same. Narrowing or widening the indications is one of the changes that most often needs careful assessment.

The term indications for use, as defined in 21 CFR 814.20(b)(3)(i), describes the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology

The disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.

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