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...
To view the full article, register now.