April 8, 2009
Risky Medical Devices Need New Proof
The FDA announced that makers of certain older and risky medical devices will have to prove that their products are safe and effective according to the New York Times. Gardiner Harris reports,
Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress instructed 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.For decades, the F.D.A. has approved devices in these categories for sale without demanding rigorous tests showing that they work safely. Investigators for the accountability office stated that “it is imperative that F.D.A. take immediate steps” to fix its system for approving such devices, and the agency agreed.
The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days detailing the products’ safety and effectiveness. . . .
April 8, 2009 | Permalink
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