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FDA Sued Over Knee Implant Market Removal

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New Jersey based RenGen Biologics has filed a lawsuit in the U.S. District Court for the District of Columbia against the Food and Drug Administration for revoking approval of the Menaflex knee repair device, calling the revocation “arbitrary and capricious.”

RenGen had applied for FDA approval in 2005 under the 510k system in which a device that is similar to an already approved device can be approved faster. RenGen claimed the Menaflex device was similar to shoulder implant devices manufactured by Johnson & Johnson. FDA scientist however disagreed and felt the device needed to follow a rigorous approval system that would include patient testing, saying that the device posed very little patient benefit.

In 2008 the FDA division head overruled the findings and approved the device, under what officials call outside pressure, including lobbyist for New Jersey lawmakers. The FDA says the decision to approve the Menaflex knee replacement was wrong and that the device is “technologically dissimilar from devices already on the market.”

The lawsuit alleges that the FDA overstepped its authority and “has forced a small U.S. company, committed to improving patients’ lives, into bankruptcy.” disclaimer: This article: FDA Sued Over Knee Implant Market Removal was posted on Thursday, June 2nd, 2011 at 4:46 pm at and is filed under Medical Device Lawsuits.

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