CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR886.3920]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 886 -- OPHTHALMIC DEVICES

Subpart D - Prosthetic Devices

Sec. 886.3920 Aqueous shunt.

(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."

[65 FR 17147, Mar. 31, 2000, as amended at 66 FR 18542, Apr. 10, 2001]