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 December of 2008. But it doesn’t end there: the Wall Street Journal unearthed some evidence of questionable conduct by the company in the months leading up to the 2008 clearance, resulting in an investigation, a new panel determination and a 510(k) re-review by the new FDA administration. The outcome? In an unprecedented decision, the FDA moved to rescind Menaflex’s clearance.
From there, the FDA offered the company a hearing under 21 CFR Part 16, which brings us to today’s press release. Part 16 allows a company to provide additional commentary before the agency takes action, but the company said that their “experience with the FDA . . . makes it clear that any such hearing would be futile.”
There’s clearly no love lost between these two, and we presume the FDA will go ahead with formally rescinding Menaflex’s clearance. More interesting will certainly be ReGen’s next move; the company plans to “seek an unbiased review of Menaflex’s approval status under U.S. law.”