FDA Proposes More Stringent Rules For Some Stents

Law360, New York (March 27, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has outlined tougher guidelines for testing drug-eluting stents to address safety concerns that patients are developing artery clots years after implantation of these devices.

The proposed guidance, which was posted on the agency’s Web site on Wednesday, is the first step the agency has taken since a meeting in December 2006 raised questions over whether these coated stents eventually cause more clots than bare-metal stents.

The FDA recommended that device manufacturers carry out more extensive analytic studies of their stents...
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