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

Scoping language

The following definitions and terms apply to this part:

Is this correct? or