eCFR Reference Browser

---

title: "21 CFR §886.3340"

source: "https://www.ecfr.gov/current/title-21/section-886.3340"

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: "886.3340"

section_subject: "Extraocular orbital implant."

cfr_reference: "21 CFR 886.3340"

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 extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

(b)Classification. Class II.

§886.3340 - Extraocular orbital implant.