{"data":{"id":"us/21-cfr-886.3400","jurisdiction":"us","citation":"21 CFR 886.3400","heading":"Keratoprosthesis.","body":"(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.\n(b) Classification. Class II. The special controls for this device are FDA's:\n(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”\n(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and\n(3) “Guidance on 510(k) Submissions for Keratoprostheses.”","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 886—OPHTHALMIC DEVICES","Subpart D—Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"aac1bf70bbcfb015b40254927ea79006d1fe4173d2c73ad5474597b766863784","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.3340","next":"us/21-cfr-886.3600"},"notice":"GroundRules: Original legal text. Not legal advice."}