Federal regulators said Wednesday that that they would ask makers of some of the riskiest medical devices to prove that their products were safe and effective — a step that critics have said was long overdue. In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976. Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress told the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which ones did not. The agency never finished that process, leaving 27 different types of devices unexamined — products that include artificial lung membranes, external defibrillators and various pacemaker components.
Please click on the link below to read the complete New York Times article:
http://www.nytimes.com/2009/04/09/business/09device.html?_r=1&ref=health
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