ABSTRACT
Congressional pressure at the time focused on giving the FDA the authority to require companies to submit postmarket data as condition for continued approval of moderate-risk medical devices under the fast-track process and would have allowed the FDA to rescind approval if this condition was not met. While the FDA already had broad authority to require postapproval studies, bills working their way through Congress underscored the growing sentiment that medical device manufacturers and the FDA ought to increase activities aimed at ensuring product safety. the people expect it will continue to be the subject of much scrutiny and that postmarket safety surveillance activity will create path to greater transparency in both cost and quality of medical devices. Under pressure, delivery organizations will look to medical device manufacturers to dramatically reduce cost. The end of the "last version plus 5%" model will mean a radical change in way that medical device companies develop products, manage their portfolios, and plan for future.
