2023-15879: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-- Premarket Notification (510(k)) Submissions." 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. The labeling recommendations in this guidance are intended to promote the safe and effective use of HPCPs and help consumers receive and understand information regarding the benefits and risks associated with the use of the device.
The agency’s own summary, as published.
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