21 C.F.R. § 886.3400 Keratoprosthesis.
Title 21 - Food and Drugs
(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.” [65 FR 17147, Mar. 31, 2000]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices
§ 886.3400 Keratoprosthesis.
