Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). User fees were renewed in 2007, with the Medical Device User Fee Amendments to the FDA Amendments Act (MDUFA II), and 2012 with the Medical Device User Fee Amendments to the FDA Safety and Innovation Act (MDUFA III). The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for MDUFA IV. Once final, MDUFA IV will be in place from Oct. 1, 2017 until Sept. 30, 2022.
Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market.
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