21 C.F.R. § 882.4300
Manual cranial drills, burrs, trephines, and their accessories
Cite as 21 C.F.R. § 882.4300 (2026)
(a)
Identification.
Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.
(b)
Classification.
Class II (performance standards).