CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART F—General Hospital and Personal Use Therapeutic Devices (§880.5025 to §880.5970) > 880.5580—Acupuncture needle.

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). 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 ,
(2) Device material biocompatibility, and
(3) Device sterility.

Code of Federal Regulations

[61 FR 64617, Dec. 6, 1996]