FDA 510(k) Process Provides Framework for Effective Medical Device Regulation

DOTmed -- The Advanced Medical Technology Association (AdvaMed) has released a white paper explaining the history and evolution of FDA's premarket notification, or "510(k)," process for medical devices and diagnostics. Approximately 90 percent of the medical devices available in the U.S. have been evaluated by FDA through the 510(k) process allowing patients to have access to essential life-saving, life-enhancing safe medical technology in a timely fashion. FDA clears approximately 3,500 510(k)s per year.