21 CFR 880.5580
§ 880.5580 Acupuncture needle.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 880.5580, § 880.5580 Acupuncture needle, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90547
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Full 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.