DAILY WEAR CONTACT LENS 510(K) GUIDANCE WILL ALLOW ACCELERATED AGING
This article was originally published in The Gray Sheet
Executive Summary
DAILY WEAR CONTACT LENS 510(K) GUIDANCE WILL ALLOW ACCELERATED AGING studies to be used to establish contact lens shelf life of beyond two years, David Whipple, associate director for contact lenses in FDA's Division of Ophthalmic Devices, said at a March 22 meeting of the agency's Ophthalmic Devices Panel in Bethesda, Maryland. Whipple noted that the agency received a "significant number of comments from manufacturers" objecting to the two year aging study limitation proposed in FDA's November 1993 draft guidance on 510(k)s for daily wear plastic contact lenses ("The Gray Sheet" Nov. 29, 1993, p. 8).