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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices. FDA is issuing this guidance to help ensure that both physicians can share and patients can understand information on the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of LASIK devices. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of LASIK devices that uniquely pertain to individual patients.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-1253.