The U.S. Food and Drug Administration (FDA) issued draft guidance to help ensure that information is available to both patients and health care professionals that clearly communicates the benefits and risks of LASIK devices. Manufacturers are prompted to include this data within their product labeling. In addition, the FDA recommends that manufacturers consider including information about how to use their devices safely and effectively and any clinical trials performed on their products.
The FDA has been concerned that patients may not get all the information they need about LASIK surgery, which can sometimes lead to complications. Patient safety is a top priority for the FDA; therefore, they brought forward this guidance to improve patient communication.
“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
Dr. Shuren continues, “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK.”
This draft guidance is based on the FDA’s understanding of current industry practices for labeling LASIK devices and feedback from patient groups, industry representatives, and other stakeholders. The agency believes this guidance will help ensure that all the necessary information is available to the patients and health care providers to communicate without leaving any stone unturned about the benefits and risks of LASIK surgery.
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Written by the digital marketing team at Creative Programs & Systems: www.cpsmi.com