FDA Warns Edwards Over Heart Device Reporting

Law360, New York (April 8, 2010, 2:56 PM EDT) -- The U.S. Food and Drug Administration has hit Edwards Lifesciences LLC with a warning over the company's alleged inability to properly and timely report six complaints of adverse events linked to its annuloplasty ring devices and a pericardial heart valve device.

The FDA on Tuesday released the warning letter sent to Edwards' Irvine, Calif., headquarters on March 1 alerting the company that the devices are misbranded under the Federal Food, Drug and Cosmetic Act due to its inadequate reporting of these complaints.

The agency discovered these...
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