Contact Lens Safety and the FDA: 1976 to the Present

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.