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Tag Archive: PhRMA

Dangerous medical device ‘loophole’ still wide open


Consumer groups are crying foul over bipartisan legislation to extend user fees for pharmaceuticals and medical devices. They say that the bill, which the Senate hopes to pass this week, is missing a provision that would close a dangerous loophole in medical device safety.

Right now, the Food and Drug Administration (FDA) does not have the power to require medical device manufacturers to prove they've fixed  known safety flaws before they put a new device on the market. Sen. Jeff Merkley, D-Ore., and Rep. Edward Markey, D-Mass., both introduced bills earlier this year that would give the FDA this ...

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