A report from the New York Times last week says that the F.D.A. is asking makers of some of the more risky medical devices to prove their products are safe and effective. This process was kicked into action by a January 2009 report from the Government Accountability Office that scolded the F.D.A. for failing for decades to fix its system of renewing categories of devices that have been on the market since 1976. Devices that were in existence before 1976 are know as legacy devices.
In 1976 the F.D.A. was told to reexamine all medical devices new and old and reclassify them, they never got around to it. This left 27 different types of medical devices that were simply approved without the proper testing. The G.A.O. and F.D.A. both agreed that the agency needs to take steps immediately to right this wrong.
Quotes:
“We have to review each device type separately, It will take some time.”
-FDA Spokeswoman Mary Long
“It’s great that F.D.A. is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness.”
-Diana Zuckerman, President of the National Research Center for Women and Families
