HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Wednesday, 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,

Federal regulators said Wednesday that that they would ask makers of some of the riskiest medical devices to prove that their products are safe and effective — a step that critics have said is 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 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. . . .

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