FY 2011 MDUFA Performance Report
I am pleased to present the Food and Drug Administration’s (FDA’s) fiscal year (FY) 2011 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 ninth report on medical device user fee review performance, and the fourth 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, 2011, indicate that FDA has met or has the potential to meet or exceed 17 of 21 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, including completed and pending reviews, for Tier 2 performance goals show that FDA has met or has the potential to meet or exceed 15 of 21 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.
However, we recognize that although FDA is meeting most of its MDUFA goals, the total time for review – a combination of FDA time and industry time – has been increasing. Therefore in January 2011, FDA announced a Plan of Action that included 25 specific actions we would take this year to improve the predictability, consistency, and transparency of our premarket programs. Subsequently, FDA has taken or is taking actions to:
- create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risk;
- ensure predictable and consistent recommendations, decision-making, and application of the least-burdensome principle; and
- implement efficient processes and use of resources.
These actions exemplify FDA’s commitment to increasing the timely availability of safe and effective new medical devices to patients and healthcare providers.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Printable version of the FY 2011 MDUFA Performance Report