Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Noncorrective contact lens crackdown: Nov. 24 FDA 1guidance clarifies that all contact lenses, including noncorrective lenses intended only to change the normal appearance or color of the eye, are subject to premarket authorization by FDA. Certain decorative lenses previously were regulated as cosmetics, but a November 2005 amendment to the Food, Drug & Cosmetic Act requires that all contact lenses be regulated as prescription devices and be dispensed only by licensed practitioners. Like all contact lenses, decorative lenses "can cause a variety of serious injuries or conditions" in the absence of supervision by a qualified eye care professional, the document states...