MASSDEVICE ON CALL — Consumer advocacy group Consumers Union submitted a letter to U.S. healthcare regulators, offering more than 11,000 signatures in favor of more stringent oversight of implantable medical devices.
CU urged the FDA to require that all high-risk medical implants undergo clinical testing vie the agency’s premarket approval process, rather than allowing them through via the less-stringent 510(k) pathway, which requires only that a device demonstrate that it’s "substantially equivalent" to a product already cleared by the FDA.
Citing the high-profile recall and subsequent lawsuits over metal-on-metal hip implants, CU asked regulators to take stronger action to prevent medical device makers from putting potentially faulty devices on the market.
"A MoM hip sold by Johnson & Johnson (NYSE:JNJ) had a 40% failure rate but the company continued to sell the remainder of their inventory, despite the knowledge of the failure rate," according to a CU press release, citing a New York Times report. "This kind of irresponsible behavior must stop. Requiring a more thorough review up front, as the current order proposes, will help to keep flawed devices from the market."
A relative newcomer, CU has made its mark on medical device lobbying. Representing the advocacy arm of Consumer Reports, CU has also has been involved in regulatory discussions involving FDA user fees and clearance status for Aptus Endosystems’ HeliFX endostapling system.
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