ReGen Biologics sues FDA over 510(k) rescission

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 Ger...