§880.5580. Acupuncture needle.
21 C.F.R. § 880.5580
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.
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:
Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
Device material biocompatibility, and
Device sterility.
Notes, amendments, and revision history
Amendments
[61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
Amendments
[61 FR 64617, Dec. 6, 1996, as amended at 84 FR 71815, Dec. 30, 2019]