21 CFR § 882.4325 - Cranial drill handpiece (brace).

---
identifier: "/us/cfr/t21/s882.4325"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.4325 - Cranial drill handpiece (brace)."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.4325"
section_name: "Cranial drill handpiece (brace)."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---


# 882.4325 Cranial drill handpiece (brace).

(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.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]