21 CFR §880.5580

1. (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.
2. (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. (1)Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
   2. (2)Device material biocompatibility, and
   3. (3)Device sterility.