Reuse

Reuse is kept separate from refurbishing or repair for resale, which are different activities. Instructions that make reuse possible, such as disassembly or on-site sterilization steps, become part of the labeling and have to be validated.

Use of a device more than once on a single patient or on more than one patient. Actions necessary for reuse of a device may include instructions for assembly/disassembly, on-site sterilization or disinfection, etc. This definition does not include the refurbishing or repair of a device for redistribution or resale.

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