DotMedNews, Despite criticism, FDA process deemed safe

DotMedNews, Despite criticism, FDA process deemed safe (09/16/10):

A study released Wednesday by the Advanced Medical Technology Association (AdvaMed) confirms the safety of the U.S. Food and Drug Administration’s 510(k) clearance process, the premarket review process for low- and moderate-risk devices.
The research, conducted by the Battelle Memorial Institute, and funded in part by AdvaMed, found that of the 47,000 medical devices cleared by the FDA through the 510(k) process since 1998, only 0.16 percent were involved in a Class I, or serious, recall. Class I recalls involve products that have the potential to cause serious health problems. …