Regulatory News In Brief

AbioCor HDE: Review of Abiomed's total artificial heart humanitarian use exemption (HDE) application is challenging the agency to consider how much weight should be given to the probable benefit of devices when adverse event risks are significant. On June 23, an FDA panel narrowly voted (7-6-1) that the artificial heart failed to meet criteria for HDE approval (1"The Gray Sheet" June 27, 2005, p. 5). However, FDA is signaling that it will look at more than the final panel vote in judging whether to approve the HDE. Potential artificial heart users "are at the end of their life. They don't have any other alternatives, and for them, maybe the chance to live another couple of months is worth the risks from the adverse events that the device presents," CDRH Office of Device Evaluation Director Donna Bea Tillman said June 28 during a conference on AAMI Human Factors, Ergonomics and Patient Safety for Medical Devices in Washington, D.C. "Trying to make that balance, I think, is something that continues to be a real challenge," the ODE official added...