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December 2009

FDA Announces New Effort to Seek Higher Test Data on Medical Devices

The New York Times reports today that the FDA, in a long overdue move, will require stricter test data from the manufacturers of medical devices used in humans. The Agency has long been under fire from Consumer groups and members of Congress who cite increasing problems in recent years with such devices as heart defibrillators, pacemakers and cardiac stents. These groups contend the problems with these devices should have been identified much earlier in the clinical testing phase so they could be remedied, or, at the very least, so doctors and their patients could be properly warned about potential negative effects. Some of these problems have lead to deaths in the patients who have used them. Other patients were required to undergo surgery to remove the defective devices and have them replaced.

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