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FDA drafts guidance on patient labeling information for LASIK devices

In a draft guideline released by the US Food and Drug Administration on July 28, content and planning recommendations for labeling a patient for laser-assisted in situ keratomileusis (LASIK) are presented.

Out of concern that some patients do not receive and/or understand information about the risks and benefits of LASIK procedures, the authors provide content and design recommendations for patient labeling. The labeling recommendations are intended to promote physician-patient discussion of the benefits and risks of LASIK.

The recommended format and content of the patient label should include eye information and Surgery and an explanation of what LASIK is and what the laser does. Indications for use should be presented, and benefits, potential uses, contraindications, warnings, precautions, and patient risk information should be discussed. Additionally, the label should include information about what the patient should expect before, during, and after surgery, as well as relevant clinical information, while providing specific context about the LASIK device to be used. be used in the process.

“The FDA recommends that a copy of the patient information sheet be given to the patient so that the patient can refer back to this important information. solutionThe authors wrote. “FDA has also encouraged device manufacturers to develop a program to ensure this the sick are well informed about the risks of LASIK.”


The American Academy of Ophthalmology has reiterated its longstanding guidelines on LASIK


Additional information:
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hint: FDA drafts guidance on patient labeling information for LASIK devices (2022, August 1) Retrieved August 1, 2022 from https://medicalxpress.com/news/2022-08-fda-guidance-patient-lasik -devices.html

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FDA drafts guidance on patient labeling information for LASIK devices Source link FDA drafts guidance on patient labeling information for LASIK devices

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