title: 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.
authors.affiliation: Office of Device Evaluation, Division of Ophthalmic and Ear, Nose, and Throat Devices, Center for Divices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD 20850, USA. james.saviola@fda.hhs.gov
authors.forename: James F
authors.initials: JF
authors.lastname: Saviola
mesh_terms: D003257:Consumer Product Safety; D018639:Contact Lens Solutions / Q000009:adverse effects; D003261:Contact Lenses / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D004869:Equipment Safety; D006801:Humans; D033181:Information Dissemination / Q000379:methods; D020407:Internet; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends*
chemical_list: D018639:Contact Lens Solutions