21 CFR § 882.4300 - Manual cranial drills, burrs, trephines, and their accessories

---
identifier: "/us/cfr/t21/s882.4300"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.4300 - Manual cranial drills, burrs, trephines, and their accessories"
title_number: 21
title_name: "Food and Drugs"
section_number: "882.4300"
section_name: "Manual cranial drills, burrs, trephines, and their accessories"
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"
---


# 882.4300 Manual cranial drills, burrs, trephines, and their accessories

(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).