[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5580]

[Page 385]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 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]