Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations—Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 87 FR 50629

Summary

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations—Premarket Notification (510(k)) Submissions.” FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. The labeling recommendations in this draft guidance are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks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. This draft guidance is not final nor is it for implementation at this time.