Device Company Seeks D.C. Circuit Review of FDA 510(k) Rescission Order

By Jamie K. Wolszon –

ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a collagen scaffold device, marketed as Menaflex.  The petition for review is the most recent development in ongoing controversy surrounding FDA rescission of 510(k)s.  For many years industry has questioned FDA's statutory authority to rescind a 510(k) clearance.  One cannot determine from the petition for review if that argument will be a basis for the company's lawsuit.

The debate surrounding FDA’s 510(k) clearance for ReGen’s Menaflex (K082079) appears to have been an important catalyst for FDA’s recent review of the overall 510(k) process.  In light of criticisms from lawmakers and the trade press about the Menaflex clearance process, in April 2009 FDA Principal Deputy Commissioner Joshua Sharfstein tasked three high-ranking FDA officials, including then-Associate Commissioner for Policy and Planning Jeff Shuren (now CDRH director), with leading an internal review to investigate the clearance.  The agency indicated that the review of the Menaflex clearance should “determine whether changes should be made to the agency’s policies, processes, procedures, or practices to better protect the integrity of FDA’s decisionmaking.”

The September 2009 preliminary report, “Review of the ReGen Menaflex: Departures from Processes, Procedures and Practices Leave the Basis for a Review Decision in Question,” identified alleged procedural irregularities in the clearance process for that particular device.  The report recommended an independent scientific re-evaluation of the Menaflex substantial equivalence determination.  The report also recommended that the agency launch an independent review of the 510(k) program at CDRH.

Beginning in the fall of 2009, FDA undertook the recommended scientific re-evaluation of the determination of the device’s substantial equivalence.  An advisory committee considered the device in May 2010.  As a result of the re-evaluation of the device, FDA announced in October 2010 its intention to rescind the clearance for the device.

As for the recommendation for a review of the overall 510(k) program, we previously reported that since September 2009, CDRH has been reviewing the operation of the 510(k) program.  In August 2010, the 510(k) working group issued a preliminary report that included a recommendation that CDRH consider issuing a regulation to define the “scope, grounds, and appropriate procedures, including notice and an opportunity for a hearing, for the exercise of its authority to fully or partially rescind a 510(k) clearance.” 

This process, according to the report, would include consideration of whether FDA needs additional rescission authority.  Although the FDC Act does not state that the agency has 510(k) rescission authority, FDA believes that this authority is implicit in the statute.  FDA claims in the report that the agency has issued a limited number of partial and full rescissions.  It is not clear if any of the rescissions were issued over the objection of the 510(k) holder, as has happened in the ReGen case.

We previously reported (here and here) that several lawmakers from both the House and the Senate wrote FDA urging the Agency to delay implementation of the rescission proposal until the IOM issued its report on the evaluation of the 510(k) process, which is expected to be completed in the summer of 2011. 

FDA granted this request:  As we previously reported, FDA’s report in January 2011 included certain items that it would implement immediately and others for which it would wait until it IOM concluded its review.  The rescission proposal was one of the items that FDA postponed to allow for IOM input.