Biologics

ReGen Biologics appeals loss to FDA

April 9, 2014 by Brad Perriello

ReGen Biologics asks a federal appeals court to overturn its loss of a lawsuit filed against the FDA over its Menaflex device, arguing that the federal watchdog agency lacked the authority to rescind its clearance of the knee implant.

ReGen Biologics’ long battle against the FDA entered a new phase this year, with the medical device company’s appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA’s decision to rescind the clearance granted to ReGen’s Menaflex knee implant.

Oral arguments were held in the U.S. District Court of Appeals for the D.C. Circuit yesterday in ReGen’s appeal of the 2011 lawsuit it filed against the FDA, its Center for Devices & Radiological Health chief Dr. Jeffrey Shuren and HHS head Kathleen Sebelius. In April 2013 a lower court granted the FDA’s motion to dismiss, agreeing that the federal watchdog agency was within its rights to turn its green light for Menaflex to red.

 

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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