§ 886.3400. Keratoprosthesis.
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/us/cfr/t21/s§ 886.3400·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]