Is The Medical Device Review System Flawed?

Law360, New York (August 1, 2011, 1:14 PM EDT) -- At the request of the United States Food and Drug Administration, the Institute of Medicine appointed a committee to review the process under which medical devices are analyzed for reasonable assurances of safety and effectiveness as required by the Federal Food, Drug and Cosmetic Act (FFDCA). Manufacturers of medical devices that may have a moderate risk to patients cannot market the devices until the devices make their way through the 510(k) process — a reference to Section 510(K) of the FFDCA.

Due to growing concerns of...
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