21 CFR 882.4325

§ 882.4325 Cranial drill handpiece (brace).

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 882.4325, § 882.4325 Cranial drill handpiece (brace), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90691
Permanent ID: ys:prov:90691@1
SHA-256: 9fd3660007545b8bb00f2f5be39b3ba14cda2f89e150705554f0ff8c651f0001

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Full text

(a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.