Consumer group demands more med-tech oversight from MDUFMA III | Regulatory Roundup

February 8, 2012 by MassDevice staff

Patient advocacy group Consumer Union petitions the FDA to implement more stringent oversight for medical devices in the new medical device user fee agreements, to prevent the public from being used "as guinea pigs when it comes to something as important as a medical implant."

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Consumer Union demanded that a new user fee deal the medical device industry brokered with the FDA include more stringent oversight of med-tech makers.

"We shouldn't be used as guinea pigs when it comes to something as serious as a medical implant," according to the organization's website. "Medical devices should not be ticking time bombs!"

The patient advocacy group published a series of changes it would like included in the new Medical Device User Fee & Modernization Act, including banning all permanently implantable medical devices from the 510(k) clearance pathway and excluding all pre-1976 technology from serving as predicates for new devices.

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"Because of intense lobbying from the medical device industry, more than 90% of devices do not have to undergo testing on humans before they are sold to, or implanted in, us," according to Consumer Union. "That means heart valves and other high-risk devices can receive less scrutiny and testing than a drug for an upset stomach."

The group also called for heightened post-market surveillance of med-tech to ensure that patients are quickly informed if there is a defect or recall.

"When an implanted device is recalled or removed from the market, patients cannot simply stop using them," the organization wrote. "Even if the pre-market approval processes are improved in 2012, closely monitoring what happens when devices such as hip joints, pacemakers, stents, breast implants and insulin pumps enter the market becomes crucial to providing information about their safety and effectiveness."

Device makers recently reached a tentative agreement with the FDA for the next generation of user fees, which will be enshrined in MDUFMA III.

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