Unapproved PRK laser marketing and use to be addressed in FDA warning letters.
This article was originally published in The Gray Sheet
Executive SummaryUNAPPROVED PRK LASER MARKETING AND USE IN U.S. will be addressed in four upcoming warning letters to companies and physicians, FDA says. The agency is issuing the letters in an effort to crack down on the growing number of individuals seeking to tap the U.S. market for photorefractive keratectomy surgery before the first PRK laser is approved for sale.
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