{"data":{"id":"us/21-cfr-880.5580","jurisdiction":"us","citation":"21 CFR 880.5580","heading":"Acupuncture needle.","body":"(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.\n(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:\n(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,\n(2) Device material biocompatibility, and\n(3) Device sterility.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES","Subpart F—General Hospital and Personal Use Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"c28227c2871b236083e7f5777a6540943280b5e01fbb3188f097835d662c6be3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-880.5570","next":"us/21-cfr-880.5630"},"notice":"GroundRules: Original legal text. Not legal advice."}