Regulations last checked for updates: May 03, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 882.4310 - Powered simple cranial drills, burrs, trephines, and their accessories.

(a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

(b) Classification. Class II (performance standards).

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
cite as: 21 CFR 882.4310