21 C.F.R. § 880.5580 Acupuncture needle.
Title 21 - Food and Drugs
(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. [61 FR 64617, Dec. 6, 1996]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices
§ 880.5580 Acupuncture needle.
