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- Denise Hampton, Joffre Angelo Green, Marc Robboy, and Malvina Eydelman.
- Division of Ear, Nose and Throat Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
- Eye Contact Lens. 2017 Jan 1; 43 (1): 2-4.
AbstractThe 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.
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