Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Issue Date: July 27, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Labeling, Ophthalmic
Status: Final

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

FDA is issuing this guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses. These labeling recommendations are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.

Download the Guidance Document