21 CFR §886.5919

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity.
   2. (2)The patient contacting components of the device and packaging components must be demonstrated to be biocompatible.
   3. (3)Performance testing must demonstrate the sterility of the device.
   4. (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. (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. (6)Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device.
   7. (7)Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses.
   8. (8)Labeling must include the following:
      1. (i)Instructions on how to correctly use the device, including instructions to use fresh components for each use;
      2. (ii)Descriptions of compatible contact lenses;
      3. (iii)Descriptions of compatible care solutions;
      4. (iv)A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and
      5. (v)A precaution against use with lenses that have not been demonstrated to be compatible with the device.