Title 21 Part 880 → Subpart F → §880.5580

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5580

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5580

e-CFR data is current as of August 22, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5580

Title 21: Food and Drugs
Subpart F—General Hospital and Personal Use Therapeutic Devices

§880.5580   Acupuncture needle.

(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.

[61 FR 64617, Dec. 6, 1996]