FY 2010 MDUFA Performance Report
I am pleased to present the Food and Drug Administration’s (FDA’s) fiscal year (FY) 2010 Performance Report to Congress for the Medical Device User Fee Amendments of 2007 (MDUFA II). The enactment of MDUFA II reauthorized medical device user fees for FY 2008 through FY 2012. This is the eighth report on medical device user fee review performance, and the third to reflect the more demanding goals set under MDUFA II.
Under MDUFA II, FDA uses a two-tier approach for each submission type. Tier 1 performance goals focus on completing a large percentage (from 50 to 90 percent) of review cohorts in a shorter amount of time. Preliminary data, including completed and pending reviews for Tier 1 performance goals through September 30, 2010, indicate that FDA has met or has the potential to meet or exceed 14 of 16 Tier 1 performance goals. Tier 2 performance goals focus on completing a larger percentage (from 90 to 98 percent) of review cohorts, but over longer time frames. Preliminary data for Tier 2 performance goals show that FDA has met or has the potential to meet or exceed 10 of 16 Tier 2 performance goals. As our experience with Tier 1 and Tier 2 performance goals increases, we will continue with efforts to improve the efficiency and consistency of the review processes and ultimately, performance.
FDA also will continue to incorporate an interactive review process, collaborate closely with stakeholders on the development of guidance, provide educational materials to improve communication, and conduct quarterly performance meetings to improve transparency. Combined with performance improvements, these efforts are expected to improve the quality of submissions by applicants and provide more timely and consistent reviews by FDA. 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 increasing availability of important new medical devices to patients and healthcare providers.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs