title: Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort.
abstract: The premarket review of contact lenses and accessories by the FDA involves the assessment of nonclinical and clinical information in support of clearance or approval of marketing applications. The review process for these medical devices, including attributes, which may contribute to comfort for lens wearers, is summarized, as are mechanisms by which FDA continues to assess and improve recommendations through the review process and through collaboration with external entities.
authors.affiliation: Division of Ear, Nose and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Denise
authors.initials: D
authors.lastname: Hampton
authors.forename: Joffre Angelo
authors.initials: JA
authors.lastname: Green
authors.forename: Marc
authors.initials: M
authors.lastname: Robboy
authors.forename: Malvina
authors.initials: M
authors.lastname: Eydelman
mesh_terms: D003263:Contact Lenses, Hydrophilic; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D062307:Medical Device Legislation; D010352:Patient Dropouts; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*