ReGen Sues FDA Over Knee Surgery Device (OTW)
ReGen Biologics sues FDA over 510(k) rescission (MassDevice)
The lawsuit calls the decision to pull the FDA clearance "arbitrary and capricious, an abuse of discretion, not in accordance with law, and in excess of statutory jurisdiction, authority and limitations" and asks the U.S. District Court for the District of Columbia to nullify the rescission.
ReGen Rejects FDA (OTW)
ReGen Biologics has rejected the FDA's offer for another hearing to make the case for the Menaflex device, 510(k) cleared by the agency in 2008. "Enough is enough," said Gerald Bisbee, Jr., Ph.D., the company's chair, president and CEO. He says safety and effectiveness issues were settled at a November 2008 FDA Advisory Panel meeting. "
ReGen Says "Enough is Enough" (HealthPointCapital by Lauren Uzdienzki)
ReGen called the FDA out for its "blatantly arbitrary and unfair" practices in a press release this afternoon, declining a hearing over the rescission of its Menaflex device.
In their press release, ReGen recounted six years of drama with the FDA, including an initial 510(k) application in 2005, followed by a couple of rejections and finally a clearance in Decemb...
