Distributes

This is a device tracking term from 21 CFR 821. Distribution under an IDE and distribution for teaching, law enforcement, research or analysis are excluded, so those shipments do not trigger tracking duties.

Distributes means any distribution of a tracked device, including the charitable distribution of a tracked device. This term does not include the distribution of a device under an effective investigational device exemption in accordance with section 520(g) of the act and part 812 of this chapter or the distribution of a device for teaching, law enforcement, research, or analysis as specified in § 801.125 of this chapter.

21 CFR, 821.3