21 CFR 882.4310
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.4310, § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90690
- Permanent ID
ys:prov:90690@1- SHA-256
0e2b13d514c51d51d33088c74aebae6e60d71e9a9b64e920619387c706728dde
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.