eCFR Reference Browser

---

title: "21 CFR §886.3920"

source: "https://www.ecfr.gov/current/title-21/section-886.3920"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "886"

part_subject: "OPHTHALMIC DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "886.3920"

section_subject: "Aqueous shunt."

cfr_reference: "21 CFR 886.3920"

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 aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.

(b)Classification. Class II. The special controls for this device are FDA's:

(1)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”

(2)“510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and

(3)“Aqueous Shunts—510(k) Submissions.”

§886.3920 - Aqueous shunt.