21 CFR 886.3400
§ 886.3400 Keratoprosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 886.3400, § 886.3400 Keratoprosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90968
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Full text
(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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.