21 CFR § 886.3200 - Artificial eye.

---
identifier: "/us/cfr/t21/s886.3200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.3200 - Artificial eye."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.3200"
section_name: "Artificial eye."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---


# 886.3200 Artificial eye.

(a) *Identification.* An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

(b) *Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9, if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.

[61 FR 1124, Jan. 16, 1996, as amended at 66 FR 38813, July 25, 2001]