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FDA To Tighten Norms For Approval Of Medical Devices
The FDA publicly acknowledged only in September last that it approved a device to help with knee-replacement surgeries—a device the agency’s own scientists said often failed—only after it received pressure from a cohort of Democratic congressmen from New Jersey, where the device’s manufacturer, ReGen Biologics, is located.
The $3000 device was known as the Menaflex, a “collagen scaffold” that supported a damaged meniscus in the knee. It failed its initial reviews but received approval in December of last year anyway, during the waning days of the Bush Administration.
Jeffrey Shuren, acting director of the FDA's device division, acknowledged weaknesses in clinical trials used to approve some cardiovascular devices.
He said he wanted companies to work closely with the FDA in setting specific goals for their studies, which hasn't always been the case. "We want to be clear to manufacturers about what is expected of them," he said.
An official at AdvaMed, the device industry trade group, however, told the Wall Street Journal that the FDA spent 1,200 hours reviewing each device application, and companies too submitted large amounts of data before approval was granted. The official also said that the authors of the JAMA study didn’t have access to all of the data companies submitted to the FDA.
Source-Medindia
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