Thursday, June 17, 2021

FDA Qualified PROWL-SS Tool for Evaluating LASIK Devices

The tool provides critical patient-reported outcomes data about vision symptoms and satisfaction with vision after LASIK surgery.

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FDA - Center for Devices and Radiological Health

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.

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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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