To correct this error, the agency will begin the process to rescind the product's marketing clearance. Before beginning this process, the FDA has asked the product's manufacturer, ReGen Biologics Inc., to meet with the agency to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.
The device, called Menaflex Collagen Scaffold, was cleared for marketing by the FDA in December 2008 for the repair and reinforcement of the meniscal tissue in the knee. The meniscus is a C-shaped disk of fibrocartilage in the knee that acts as a cushion between the ends of bones in the joint and helps lubricate the joint.
The September 2009 report recommended a scientific re-evaluation of the device because the administrative record did not supply a basis for the FDA's December 2008 decision to clear that was adequate to dispel questions about the role of outside pressures on the review process. This re-evaluation, initiated in the fall of 2009, included a team of scientists at the agency who were not involved in previous reviews of the device. Another advisory committee meeting was also held in March 2010.
The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called "predicate devices." These differences can affect the safety and effectiveness of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency.
It is unlikely that explanting the device will generally be appropriate or necessary because the device is resorbed and replaced with new tissue. However, patients who have had the Menaflex device implanted should talk with their surgeon or other health care professional about what, if any, steps should be taken.
A rescission is an FDA action to revoke a marketing clearance later determined to be erroneous.
After implementing a rescission, the FDA prohibits the manufacturer from further U.S. marketing until the agency approves or clears a new marketing application, or grants a classification petition. After the FDA issues a rescission notice, a manufacturer has the option of requesting a regulatory hearing with the FDA or can choose to voluntarily withdraw their marketing clearance. The device will remain on the market until the agency rescinds its clearance.
The circumstances surrounding the Menaflex device are unique, and FDA's decision in this case does not affect the status of other devices on the market.