§ 886.4320 Corneal storage medium with preservatives including antifungals.

(a) Identification. Corneal storage medium with preservatives including antifungals is a device that is used to temporarily preserve human cornea tissue between harvesting and implantation. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. (i) The following performance characteristics of the cornea following storage in the device must be demonstrated: (A) Endothelial cell density; (B) Endothelial cell morphology; (C) Corneal transparency; and (D) Central corneal thickness. (ii) Antimicrobial activity of the device must be demonstrated at the initial and maximum labeled storage time. (iii) Characterization of all preservatives, including antifungals, must include the following: (A) Characterization of impurities, heavy metal analysis, concentration, and dissolution; and (B) Chemical activity of all preservatives over the labeled use life of the device. (2) Performance data must demonstrate the sterility of the device. (3) The device must be demonstrated to be biocompatible and non-pyrogenic. (4) Performance data must support the claimed shelf life by demonstrating continued sterility, controlled bioburden, package integrity, and device functionality over the intended shelf life. (5) The device and each of its components (e.g., antifungal, antibiotic, medium) must be demonstrated to be compatible with their respective commercial container closure system/packaging. (6) An analysis must be provided that identifies and evaluates any contribution to the development and spread of antimicrobial resistance. (7) Labeling must include the following instructions: (i) Rinsing of cornea prior to transplantation; and (ii) Complete dissolution of all preservatives.