Does the new law do anything to strengthen postmarket surveillance?
MDUFMA authorizes additional appropriations for postmarket surveillance — $3 million for FY 2003, $6 million for FY 2004, and “such sums as may be necessary” in subsequent years. An authorization for additional appropriations does itself not provide FDA any additional resources. For FDA to receive these resources, Congress would have to pass appropriations acts providing these additional funds to the agency. In addition, MDUFMA requires FDA to conduct, and submit to Congress by January 10, 2007, a study of: • the effect of medical device user fees on FDA’s ability to conduct postmarket surveillance. • the extent to which device companies comply with postmarket surveillance requirements. • any improvements needed for adequate postmarket surveillance, and the amount of funds needed to do so. • recommendations as to whether, and in what amount, user fees should be used for postmarket surveillance, if extended beyond FY 2007.
