WASHINGTON, D.C. — The following quote is attributed to William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices and Radiological Health:
“LASIK is a surgical procedure intended to reduce a person’s dependency on glasses or contact lenses. Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that can result from LASIK.
“The FDA has used medical device development tools to help us reach regulatory decisions and include these important patient-reported outcomes.
“Patient-Reported Outcomes with LASIK Symptoms and Satisfaction—also known as PROWL-SS—has been qualified as a scientifically validated tool to assess individuals’ symptoms and satisfaction with vision associated with LASIK surgery.
“This tool will support the FDA’s premarket and post-market regulatory decision making and can be used by manufacturers for the development and evaluation of LASIK devices.
“PROWL-SS provides patients, eye-care providers and manufacturers with valuable information about important patient-reported outcomes.”
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