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Although you can comment on any guidance at any time (see 21 CFR 10. 115(g)(5)), to ensure that the FOOD AND DRUG ADMINISTRATION considers your comment on a draft guidance before it begins work on the final version of the particular guidance, submit either online or written comments upon the draft guidance before the close date.

If unable to submit comments online, please mail created comments in order to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document’s docket number: FDA-2022-D-0986


Docket Number:
FDA-2022-D-0986
Issued by:

Guidance Issuing Office

Center for Devices and Radiological Health

FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. 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 marking with information about specific risks plus directions for use of the particular HPCPs within conjunction with an 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 info regarding the benefits and risks associated with the make use of the particular device.