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.
This move by the FDA comes partially as a result of studies published electronically in JAMA, the Journal of the American Medical Association which detailed a number of inadequacies in the data and its analysis that is routinely performed by medical device companies and furnished to FDA for device approval. The issue of whether or not device manufacturer give sufficient information to FDA for device approval and monitoring has become a hot button issue since the United States Supreme Courts ruling in the Riegel case which essentially stripped consumers of their rights to go to court for injuries related to defective devices.
Naturally, an industry spokesman has diminished the findings of the JAMA study and of FDAs efforts to require more complete information. The spokesman noted that the information FDA requires is already rigorous and she said that industry would respond more specifically in the coming days.