ArticlesContact Lens Safety and the FDA: 1976 to the PresentSaviola, James F. O.D., F.A.A.O. Author Information From the U.S. Food and Drug Administration, Rockville, MD. Address correspondence and reprint requests to Captain J.F. Saviola, Office of Device Evaluation, Division of Ophthalmic and Ear, Nose, and Throat Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 9200 Corporate Boulevard, Room 250, HFZ-460, Rockville, MD 20850; e-mail: [email protected] Accepted August 1, 2007. Eye & Contact Lens: Science & Clinical Practice: November 2007 - Volume 33 - Issue 6 Part 2 of 2 - p 404-409 doi: 10.1097/ICL.0b013e318157e82a Buy Metrics Abstract The U.S. Food and Drug Administration (FDA) performs many different functions to fulfill its responsibility of regulating medical devices. The various roles in premarket and postmarket safety are discussed with representative historic events involving the regulation of contact lenses and lens care products. Current challenges facing the contact lens industry to maintain safe use of these medical devices are explained, and future pathways to address these challenges are considered. © 2007 Lippincott Williams & Wilkins, Inc.