Discussion over effectiveness of 510(k) process

An interesting discussion is shaping up about the future of the 510(k) process. The IOM (Institute of Medicine) recommends to chuck the 510(k) process in favor of something else - even if this something is ill-defined. The FDA vigorously defends its sickly child. AdvaMed is scared about the uncertainty facing the industry. Read this article in Fierce Medical Devices, which has several links to more background information.