StacksVerified U.S. regulatory reference

21 CFR §882.4300

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class II (performance standards).