FDA Qualified the PROWL-SS Medical Device Development Tool for Developing and Evaluating LASIK Devices The U.S. Food and Drug Administration (FDA) qualified the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) tool through the Medical Device Development Tools (MDDT) program. PROWL-SS provides patients, eye-care providers, and manufacturers with valuable information about important patient-reported vision symptoms and their level of satisfaction with vision after LASIK surgery. This tool will support the FDA's premarket and post-market regulatory decision making and can be used by manufacturers for the evaluation of LASIK devices. Questions? If you have questions about the MDDT Program, contact MDDT@fda.hhs.gov. |
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