Reusable medical device

Reusable devices need validated reprocessing instructions, and FDA expects that validation in premarket submissions for many device types. Design matters too, since features that are hard to clean make reprocessing unreliable.

A device intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing between uses.

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