Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient and Consumer Advocacy Group Intention to Participate

The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA 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. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.