I am pleased to present the Food and Drug Administration’s (FDA’s) fiscal year (FY) 2009 Performance Report to Congress for the Medical Device User Fee Amendments of 2007 (MDUFA II). This is the seventh report on medical device user fee review performance, and the second to reflect the more-demanding goals set under MDUFA II.
Medical device user fees were first authorized in 2002 under the Medical Device User Fee Modernization Act (MDUFMA I) for FY 2003 through FY 2007. MDUFMA I provided FDA an important source of additional resources that allowed us to pursue an ambitious set of negotiated performance goals. The enactment of MDUFA II reauthorized medical device user fees for FY 2008 through FY 2012.
FDA has continued to meet or exceed most review-time goals as we completed the transition from MDUFMA I to MDUFA II. Under MDUFA II, FDA is applying an interactive review process to focus on our negotiated performance goals, collaborating closely with stakeholders on development of guidances, and communicating directly with applicants to facilitate timely scheduling of meetings. We are continuing to clarify our regulatory requirements and to improve the efficiency and flexibility of our review processes. To improve FDA transparency, we are providing educational materials and conducting quarterly performance meetings. These efforts are expected to improve the quality of submissions, provide more timely reviews, and increase availability to patients and healthcare providers of important new medical devices.
FDA remains dedicated to meeting the challenges and responsibilities provided by medical device user fee performance goals and commitments. The results we have already achieved, and the long-term objectives we continue to pursue, demonstrate the value of medical device user fees and FDA’s commitment to maintaining high quality and timely review of medical device submissions.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Printable version of the FY 2009 MDUFA Performance Report
Overview of MDUFMA I and MDUFA II
Report on Final MDUFMA I Performance
Report on MDUFA II Performance Goals
Report on MDUFA II Performance Goals MDUFA II Performance At-A-Glance for FY 2008 and FY 2009 Original PMAs, Panel-Track PMA Supplements, and Premarket Reports Expedited Original PMAs and Panel-Track PMA Supplements PMA Modules 180-Day PMA Supplements Real-Time PMA Supplements 510(k) Premarket Notifications