IOM report: FDA's 510(k) process needs to be revised

07/31/2011 | Wall Street Journal, The

A report by the Institute of Medicine suggested that the 510(k) process used for clearing medical devices should be overhauled because dependence on "substantial equivalence cannot assure that devices reaching the market are safe and effective." The Advanced Medical Technology Association called the report a "disservice to patients." Jeffrey Shuren, director of the FDA's device center, said the agency "believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement."

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