Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) is classifying the hydrophilic re-coating solution into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hydrophilic re-coating solution's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.