FDA announces coming changes to premarket review of medical devices

The Food and Drug Administration intends to finalize guidance early next year on a new approach to its 510(k) program for pre-market review of medical devices. “Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old,” FDA Commissioner Scott Gottlieb, M.D., said yesterday. “That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies … Through this new path, a company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles.” Among other actions, he said the agency is considering publicizing on its website devices that were approved based on comparative testing against devices that are more than 10 years old; and plans “in the next few weeks” to issue a proposed rule clarifying procedures and requirements for its De Novo program, which allows FDA to establish special controls for novel devices of the same type.