Bill Targets 'Loophole' In FDA Device Approval Process

Law360, New York (February 2, 2012, 2:26 PM EST) -- A bill introduced Wednesday in Congress aims to strengthen the U.S. Food and Drug Administration's method for approving medical devices by making it harder for the agency to sign off on devices similar to ones that have been shown to be problematic.

About 90 percent of approved medical devices get the FDA's OK through what is known as a 510(k) exception, which means the devices do not undergo clinical testing on humans before being sold, said bill sponsor U.S. Rep. Edward Markey, D-Mass.

Instead, the FDA...
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