eCFR Reference Browser

---

title: "21 CFR §886.4275"

source: "https://www.ecfr.gov/current/title-21/section-886.4275"

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: "E"

subpart_subject: "Surgical Devices"

section_number: "886.4275"

section_subject: "Intraocular fluid."

cfr_reference: "21 CFR 886.4275"

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 intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

(b)Classification. Class III.

(c)Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.

§886.4275 - Intraocular fluid.