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Expert Analysis

Drug-Device Applecart Upset Again

Law360, New York (September 30, 2014, 7:40 AM EDT) -- On Sept. 9, 2014, in Prevor v. Food and Drug Administration, the D.C. District Court held against the FDA's interpretation of the definition of a medical device included in the Federal Food, Drug and Cosmetic Act (the act). This case, going on now for five years, highlights the difficulties inherent in the statutory definitions of drug and device in the act, and raises the question — is it time for Congress to act?...

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