The US Food and Drug Administration has qualified the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction – or PROWL-SS – as a scientifically valid tool. The agency qualified PROWL-SS through its Medical Device Development Tools (MDDT) program, which was designed to expedite the approval process for devices that incorporate emerging technology.
Tool For Evaluating LASIK Outcomes Gets FDA Qualification
The US FDA has qualified a tool used to assess patient outcomes of LASIK surgery as scientifically valid. The qualification aims to support the agency’s pre- and post-market regulatory decisions and aid manufacturers in the development of devices for the procedure.
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