§886.3400. Keratoprosthesis.
21 C.F.R. § 886.3400
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.
Classification. Class II. The special controls for this device are FDA's:
“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
“510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
“Guidance on 510(k) Submissions for Keratoprostheses.”
Notes, amendments, and revision history
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]