Regulation Text
(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 of this chapter subject to the limitations in § 880.9 . 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.
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.