Restricted device

Restricted devices face extra rules on labeling, advertising and who may sell or use them, for example only on a practitioner's order. FDA also has authority over their advertising, which for most other devices falls to the Federal Trade Commission.

Restricted device means a device for which a requirement restricting sale, distribution, or use has been established by a regulation issued under section 520(e) of the act, by order as a condition of premarket approval under section 515(d)(1)(B)(ii) of the act, or by a performance standard issued in accordance with sections 514(a)(2)(B)(v) and 514(b) of the act.

21 CFR, 807.3