SINGLE-SITE PRK STUDIES ADVOCATED BY FDA FOR MODIFIED, UNAPPROVED LASERS; FDA AUTHORITY OVER PHYSICIAN-MODIFIED LASERS UNCLEAR, ODE's BROGDON SAYS
This article was originally published in The Gray Sheet
Executive Summary
Ophthalmic surgeons that perform photorefractive keratectomy with lasers not labeled for the vision correction procedure can obtain FDA approval of the devices on a single-site, single-laser basis, Morrix Waxler, a reviewer in the Division of Ophthalmic Devices in FDA's Office of Device Evaluation, said at an April 1 meeting of FDA's Ophthalmic Devices Panel in Gaithersburg, Maryland.
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