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GUIDANCE DOCUMENT

Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations Draft Guidance for Industry and Food and Drug Administration Staff July 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2022-D-1253
Issued by:
Guidance Issuing Office
Center 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This draft guidance recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices.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.

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Submit Comments Online

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:

Dockets Management
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.

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