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Lawmakers’ Silly Season No Laughing Matter for Device Industry

Medical device firms are always one recall away from increased scrutiny

Michael Causey
Wed, 03/28/2012 - 10:29
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Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if President Obama is reelected in November.

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The climate is not great for medical device firms, which are always one recall away from increased scrutiny. Add to that a recent poll from Consumer Reports that says the public wants more medical device regulation and less risk.

The poll was released just as House and Senate committees have issued draft legislation to reauthorize the statute governing medical devices, and at a time when the FDA’s process for reviewing new implants has come under intense criticism.

 …

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