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In Brief: Ophthalmic laser correction

This article was originally published in The Gray Sheet

Executive Summary

Ophthalmic laser correction: The Division of Ophthalmic Device's Diagnostic and Surgical Devices Branch in FDA's Office of Device Evaluation has set an internal goal of reviewing all investigational device exemption applications for refractive lasers within 10 days, FDA staffers say. "The Gray Sheet" (Nov. 25, I&W-3) incorrectly reported that the goal was set only for IDE applications received from physicians under the division's policy to bring home-built lasers into compliance...
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