---
kind: "section"
citation: "21 C.F.R. § 882.4325"
title: "21"
number: "882.4325"
heading: "Cranial drill handpiece (brace)."
url: "https://uscodex.org/cfr/21/882.4325"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 882.9](/cfr/21/882.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

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