Edwards Lifesciences warning letter
This article was originally published in The Gray Sheet
Executive Summary
FDA cites quality system deviations, including complaint handling, documentation and training issues, in a warning letter to Edwards Lifesciences, announced Feb. 20. The warning, which stems from an inspection of the firm's Irvine, Calif., facility, notes that Edwards will not receive premarket approval for devices "reasonably related to those issues" until they are resolved. Edwards says the warning will not have a material impact in 2007 and it does not expect delays for product launches or clinical trials, including the U.S. pivotal trial for its Sapien transcatheter aortic heart valve, slated to begin this quarter. The firm continues to anticipate PMA approvals for its Magna mitral tissue valve and a superficial femoral artery indication for its LifeStent self-expanding stent by year-end (1"The Gray Sheet" Dec. 18, 2006, p. 11). Edwards is scheduled to meet with FDA regarding the warning letter in March...