The Food and Drug Administration (FDA) will be holding its first patient and consumer advocacy group meeting on the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA), which was renewed in the Medical Device User Fee Amendments of 2007 (MDUFA). The meeting will take place on January 13, 2011, from 9 a.m. to 11 a.m. Meetings will continue at least monthly during reauthorization negotiations with the regulated industry.
The statutory authority for MDUFMA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA’s negotiations with the regulated industry.
Background
MDUFMA was enacted “in order to provide the Food and Drug Administration (FDA) with the resources necessary to better review medical devices, to enact needed regulatory reforms so that medical device manufacturers can bring their safe and effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices are as safe and effective as original devices.”
MDUFMA was enacted to collect user fees for the review of medical device premarket applications, reports, supplements, and premarket notification submissions. These fees provide additional resources to make FDA reviews more timely, predictable, and transparent to applicants. MDUFMA fees and mandated appropriations for the medical device program, help FDA expand available expertise, modernize its information management systems, provide new review options, and provide more guidance to prospective applicants. The ultimate goal of collecting such fees is to help approve and clear safe and effective medical devices more rapidly, benefiting applicants, the health care community, and most importantly, patients.
Since the FDA is expected to issue changes relating to the 510(k) program under which many medical devices are approved, it is likely that many patient and consumer advocacy groups will address this issue.