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Consumers Union Urges Congress to Strengthen Medical Device Oversight
Date:11/15/2011

WASHINGTON, Nov. 15, 2011 /PRNewswire-USNewswire/ -- Consumers Union urged Congress today to strengthen the law that governs the approval of medical devices to ensure patients aren't endangered by devices that haven't been thoroughly reviewed for safety. 

The consumer group called on Congress to ensure that all implantable and life-sustaining medical devices are subject to more rigorous review by the U.S. Food and Drug Administration and to establish a better system for tracking devices after approval so patients and doctors can be notified when safety problems arise.  The Senate Health, Education, Labor, and Pensions Committee is scheduled to hold a hearing on medical devices today at 2:30 p.m.

"Lax medical device approval standards are putting patient lives at risk," said Lisa McGiffert, manager of Consumers Union's Safe Patient Project (www.SafePatientProject.org).  "The current system has allowed FDA to fast track approval of more than 90 percent of new medical devices based on whether they are similar to other devices already on the market and without clinical trails that show the devices are safe and effective.  It's time to strengthen the federal law on medical devices, not scale back oversight at the expense of patient safety."

Consumers Union's full letter to Congress follows:

November 15, 2011

Dear Member of Congress,

Consumers Union's Safe Patient Project is writing to urge you to use the opportunity provided by the upcoming reauthorization of the Medical Device User Fee Act (MDUFA) to improve the quality, safety and effectiveness of medical devices. We believe the essential goal of not harming patients can be achieved without harming true innovation.

You have been hearing that the medical device industry faces onerous regulation by FDA.  But in many respects, the device industry is far less regulated than the drug industry
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SOURCE Consumers Union
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