---
kind: "section"
citation: "21 C.F.R. § 886.4320"
title: "21"
number: "886.4320"
heading: "Corneal storage medium with preservatives including antifungals."
url: "https://uscodex.org/cfr/21/886.4320"
---

# §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.**

## Notes

### Amendments

[91 FR 24347, May 6, 2026]

### 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

[91 FR 24347, May 6, 2026]