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Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort

Hampton, Denise Ph.D.; Green, Joffre Angelo Ph.D., D.A.B.T.; Robboy, Marc O.D.; Eydelman, Malvina M.D.

Eye & Contact Lens: Science & Clinical Practice: January 2017 - Volume 43 - Issue 1 - p 2–4
doi: 10.1097/ICL.0000000000000324
Review Article

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.

Division of Ear, Nose and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.

Address correspondence to Malvina Eydelman, M.D., 10903 New Hampshire Avenue, Silver Spring, MD 20993; e-mail:

The authors have no funding or conflicts of interest to disclose.

Accepted August 01, 2016

© 2017 Contact Lens Association of Ophthalmologists, Inc.