TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES

subpart f - GENERAL HOSPITAL AND PERSONAL USE THERAPEUTIC DEVICES

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.

[61 FR 64617, Dec. 6, 1996]