---
kind: "section"
citation: "21 C.F.R. § 886.5919"
title: "21"
number: "886.5919"
heading: "Hydrophilic re-coating solution."
url: "https://uscodex.org/cfr/21/886.5919"
---

# §886.5919. Hydrophilic re-coating solution.

- (a) **Identification.** A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity.
  - (2) The patient contacting components of the device and packaging components must be demonstrated to be biocompatible.
  - (3) Performance testing must demonstrate the sterility of the device.
  - (4) Use-related risk analysis must be performed to determine if a self-selection study and human factors validation study must be conducted to demonstrate that users can correctly use the device based solely on reading the directions for use.
  - (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
  - (6) Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device.
  - (7) Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses.
  - (8) Labeling must include the following:
    - (i) Instructions on how to correctly use the device, including instructions to use fresh components for each use;
    - (ii) Descriptions of compatible contact lenses;
    - (iii) Descriptions of compatible care solutions;
    - (iv) A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and
    - (v) **A precaution against use with lenses that have not been demonstrated to be compatible with the device.**

## Notes

### Amendments

[89 FR 72323, Sept. 5, 2024]

### 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

[89 FR 72323, Sept. 5, 2024]