In Brief: Contact lens accessories reclassification
This article was originally published in The Tan Sheet
Executive Summary
Contact lens accessories reclassification: Rigid gas permeable contact lens solution, saline solution, lubricating/rewetting drops, disinfecting and conditioning products and contact lens cleaners are among the products moved to Class II from Class III under a reclassification proposal published in the Federal Register on April 1. FDA has developed a guidance document on preparation of 510(k)s for the products to serve as a Class II special control. Comments on the draft guidance are due by May 31, and on the proposed down-classification by June 7...