Experts Call FDA's Device Approval Process Flawed

Law360, New York (August 27, 2009, 3:35 PM EDT) -- Experts urged U.S. House of Representatives members Thursday to change how the U.S. Food and Drug Administration grants marketing approval for the riskiest Class III medical devices, saying that abbreviated approval pathways are continuing to allow faulty devices on the market at patients' peril.

Witnesses from the medical and regulatory community told the House health subcommittee on Thursday that the FDA should reclassify how Class III medical devices — considered the most risky and complex — are evaluated before going to market, either by requiring that...
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