FDA Update: Next | 合法醫療器材資訊網

MultifocalandaccommodativeIOLsandtheFDAapprovalprocess....Whilehundredsofmonofocalintraocularlenses(IOLs)areontheU.S.market,only10of ...

By Elaine A. Richman, PhD, Contributing Writer Interviewing David F. Chang, MD, Malvina B. Eydelman, MD, Douglas D. Koch, MD, William H. Maisel, MD, PhD, and Thomas A. Oetting, MD

Download PDF[1]

While hundreds of monofocal intraocular lenses (IOLs) are on the U.S. market, only 10 of the so-called “premium IOLs” are available. Why is it taking so long to get more of these lenses approved? And are there ways to expedite the process? The Academy and the U.S. Food and Drug Administration (FDA) explored these questions and more in a first-ever collaborative workshop held this spring.1

More than 230 clinicians, researchers, FDA leaders, and industry representatives met to discuss novel endpoints for premium IOLs, covering such topics as adverse events (AEs), methods for assessing visual disturbances, and surgeons’ expectations for IOLs providing near vision. In addition, they discus...