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FDA Issues Draft Guidance on Hydrogen Peroxide-Based Contact Lens Care Products Labeling

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations -Premarket Notification (510(k)) Submissions.

This draft guidance, when finalized, is intended to:

• Help manufacturers develop labeling with information about specific risks and directions for use of hydrogen peroxide-based contact lens care products in conjunction with a user’s prescribed contact lenses in order to reduce misuse of the product
• Promote the safe and effective use of these devices
• Ensure consumers are provided with clear information about the benefits and risks associated with the use of these devices

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

Submit comments under docket number FDA-2022-D-0986 at https://www.Regulations.gov by October 17, 2022 to ensure that the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.