FDA Panel Questions Knee Device ...WSJ Online
An FDA panel of outside experts found that there isn't enough scientific evidence to come to a firm conclusion about the benefits of a knee device approved by the FDA in 2008. The panel's statement highlights the agency's dilemma as it weighs whether it has authority to revoke a device's approval.
The chairman of the panel, orthopedic surgeon John Kelly of the University of Pennsylvania, cited inadequate and low-quality evidence about the effectiveness of the Menaflex implant made by ReGen Biologics Inc., and not enough information about the ...
