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Tool For Evaluating LASIK Outcomes Gets FDA Qualification

 
• By Brian Bossetta

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.

Patient having LASIK surgery.
PATIENT HAVING LASIK EYE SURGERY. • Source: Alamy

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.

LASIK (laser-assisted in situ keratomileusis) is one of the most common elective surgeries in the US. An estimated 10 million...

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