---
kind: "section"
citation: "21 C.F.R. § 886.3400"
title: "21"
number: "886.3400"
heading: "Keratoprosthesis."
url: "https://uscodex.org/cfr/21/886.3400"
---

# §886.3400. Keratoprosthesis.

- (a) **Identification.** A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
- (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) “Guidance on 510(k) Submissions for Keratoprostheses.”

## Notes

### Amendments

[65 FR 17147, Mar. 31, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[65 FR 17147, Mar. 31, 2000]