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December 1993

The FDA and Its Regulation of Ophthalmic Devices

Author Affiliations

Baltimore, Md

Arch Ophthalmol. 1993;111(12):1619-1620. doi:10.1001/archopht.1993.01090120041018

The Food and Drug Administration (FDA) is the division within the Department of Health and Human Services charged with enforcing federal laws regarding drugs and ophthalmic devices. Prior to 1976, items in the latter category were designated as "drugs," but the Medical Device Amendments to the Federal Food Drug and Cosmetic Act mandated a unique review process for devices, in particular for intraocular lenses.1 Since then, an enormous proliferation in the development of both drugs and medical devices has resulted in a profound expansion in the regulatory activities of the FDA. The efforts of this agency's Office of Device Evaluation (ODE) to ensure the safety and effectiveness of new products have frequently resulted in delays in availability and subsequent frustration for the medical profession, patients, and industry. More than two decades ago, sulfur hexafluoride was introduced as the first contemporary gas/vitreous substitute other than air, and the requirement of