Few topics ruffle feathers in the medical device industry as much as those related to the U.S. regulatory system. A common complaint in the industry is that it takes a lot of time and money to bring a new device to market in the U.S., especially when a premarket approval (PMA) is required. But a recent study by a group of researchers from the Yale University School of Medicine (New Haven, Conn.) suggested that the clinical evidence supporting many FDA-approved high-risk devices is relatively thin. The study is published in The Journal of the American Medical Association (JAMA).