---
kind: "section"
citation: "21 C.F.R. § 880.5580"
title: "21"
number: "880.5580"
heading: "Acupuncture needle."
url: "https://uscodex.org/cfr/21/880.5580"
---

# §880.5580. Acupuncture needle.

- (a) **Identification.** An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
- (b) **Classification.** Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, 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 [§ 880.9](/cfr/21/880.9.md). Acupuncture needles must comply with the following special controls:
  - (1) Labeling for single use only and conformance to the requirements for prescription devices set out in [21 CFR 801.109](/cfr/21/801.109.md),
  - (2) Device material biocompatibility, and
  - (3) **Device sterility.**

## Notes

### Amendments

[61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019]

### Authority

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

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019]