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WASHINGTON, DC — Today Chairman Henry A. Waxman, Subcommittee on Oversight and Investigations Chairman Bart Stupak, and Subcommittee on Health Chairman Frank Pallone, Jr., wrote to the Food and Drug Administration (FDA) requesting the agency to reexamine its decision in December to approve a medical device manufactured by ReGen Biologics, Inc. over the objection of FDA scientists.
This device, called a “collagen scaffold” and marketed as the Menaflex device, is used to reinforce and repair the meniscus, which is the natural cushion between the upper and lower leg bones in the knee.
“We understand that you may be reexamining the decision to approve this device for marketing. Given the questions raised by the FDA scientists about the lack of data on the safety and efficacy of this device, we believe this is a prudent course of action,” said Reps. Waxman, Stupak, and Pallone in the letter to the FDA. “Although we take no position on the ultimate outcome of your review, our paramount interest is in ensuring that all medical devices currently on the market are safe and effective, including the device manufactured by ReGen.”
The letter summarized documents obtained by the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations during its ongoing investigation of the process used by FDA to ensure that medical devices are safe and effective.
In addition, the Subcommittee on Health plans to hold a hearing to examine FDA’s process for evaluating the safety and efficacy of medical devices.
The letter is available online a www.energycommerce.house.gov.
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