(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.

[61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019]