Ophthalmic devices panel
This article was originally published in The Gray Sheet
Executive Summary
Convening via telephone conference call on May 20; a speaker telephone will be provided at FDA facilities on 5600 Fishers Lane in Rockville, Maryland "to allow public participation in the meeting." The panel will discuss "general issues relating to" a premarket approval application for a silicone intraocular lens, as well as IOL labeling issues and a multifocal IOL guidance document. The panel also is slated to hear and comment on a presentation on the Reanalysis of the Information on the Safety and Effectiveness (RAISE) program for extended wear contact lenses. For further information contact FDA's Daniel Brown at 301/427-1080.
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