The Medical Device User Fee & Modernization Act (MDUFA) authorizes FDA to collect user fees from medical device sponsors for product review and approval activities. First passed in 2002, MDUFA was reauthorized in 2007, and again in 2012 (i.e., MDUFA III) as part of the FDA Safety & Innovation Act (FDAISA). It commits the FDA to meet strong, measurable performance goals negotiated between the medtech industry and the agency.
Through its national medtech industry partners, MichBio is monitoring several performance commitments covering pre-submission process improvements, average time to decision goals, an independent analysis of the management of the review process, and more. We seek a FDA and its Center for Devices & Radiological Health (CDRH) that meets its commitments so that product review processes are more predictable, transparent and reasonable.