I found this article that relates to the topic. It digs a little deeper as to WHY it actually takes so long go get devices approved in the US. According to the article, Innovative medical devices take significantly longer to gain approval from the U.S. Food and Drug Administration because of administrative hurdles, rather than unfamiliarity with the new devices.
“Pioneer, first-generation medical devices in a particular category took 7.2 months longer to gain FDA approval (34 percent) than the first follow-on device, while most follow-on drugs take about 10 days (1.2 percent) longer to approve than the original drug in their class, the study found. This means that cutting-edge drugs are getting through the FDA red tape faster than groundbreaking medical devices are.”

Additionally, the article highlights challenges that factor into the delay such as:
• Little guidance from the FDA about what they need to provide in clinical trials for novel, potentially high-risk devices. For most devices, the evaluation criteria that the FDA will use to assess a new product are not made explicit before the regulatory process begins
• Devices are less likely than drugs to have demonstrated clinical safety before they go to market. In a 2009 review published in the Journal of the American Medical Association, University of California-San Francisco cardiologist Dr. Rita Redberg and colleagues found that 65 percent of FDA pre-market approvals for cardiovascular devices were based on a single study. 27 percent of studies used to support recent FDA approval of cardiovascular devices were randomized and just 14 percent of them were blinded. Unrandomized, unblinded studies have significantly greater potential for bias.

http://www.washdiplomat. com/index.php?option=com_content&view=article&id=12344:too-slow-or-too-sloppy-medical-devices-want-faster-fda-approval&catid=1535&Itemid=428