eCFR Reference Browser

---

title: "21 CFR §880.5580"

source: "https://www.ecfr.gov/current/title-21/section-880.5580"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "880"

part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"

subpart_code: "F"

subpart_subject: "General Hospital and Personal Use Therapeutic Devices"

section_number: "880.5580"

section_subject: "Acupuncture needle."

cfr_reference: "21 CFR 880.5580"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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). 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.

§880.5580 - Acupuncture needle.