FDA Considers Impact of Reversing Its Decision on Knee Device

The Food and Drug Administration is attempting to determine if it has the authority to re-evaluate and possibly reverse its decision to clear a knee device that was previously cleared despite objections from FDA scientists and managers, according to a report in the Wall Street Journal.

In 2008, the FDA granted a 510(k) clearance to ReGen Biologics' Menaflex knee-repair device, which is designed to fix meniscus tissue in the knee, according to the report. After a WSJ report last year, an FDA investigation found the advisory panel had approved the device under extreme pressure from outside parties, including members of Congress and lobbying by the company.

Officials from the FDA have questioned the reason for re-evaluating a product that is still legally on the market. Others fear a decision to re-open a decision could lead to further increasing scrutiny of medical device applications, slowing down the approval process, according to the report. A lobbyist quoted in the report said a reversal could cause serious problems for physicians who have chosen to use the device in patients.

ReGen stands by the Menaflex, saying it is safe and has questioned the legality of a new review, according to the report.

The FDA has not made a decision regarding Menaflex.

Read the WSJ's report on the FDA's Menaflex decision (subscription required).