FDA Finalizes Regs On Device Info Requests

Law360, New York (April 6, 2012, 6:52 PM EDT) -- The U.S. Food and Drug Administration issued final guidelines Friday on the first step in the medical device review process, clarifying how device manufacturers can request information from the agency about which type of approval they'll need to market a device

Under Section 513(g) of the Federal Food, Drug and Cosmetic Act, device makers can ask the FDA for information about the generic type of device they have, out of the more than 1,700 types the FDA recognizes, and which class it likely falls into, from...
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