GUIDANCE DOCUMENT
Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations Draft Guidance for Industry and Food and Drug Administration Staff July 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2022-D-1253
- Docket Number:
- FDA-2022-D-1253
- Issued by:
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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This draft guidance recommends content and formatting for patient labeling information for laser-assisted in situ keratomileusis (LASIK) devices.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.