FY 2012 MDUFA Performance Report
I am pleased to present the Food and Drug Administration’s (FDA’s) fiscal year (FY) 2012 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 tenth report on medical device user fee review performance, and the fifth to reflect the more demanding goals set under MDUFA II.
Under MDUFA II, FDA used a two-tier approach for each submission type. Tier 1 performance goals focused on completing a larger 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, 2012, indicate that FDA has met or has the potential to meet or exceed 23 of 27 Tier 1 performance goals. Tier 2 performance goals focused 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 20 of 27 Tier 2 performance goals. As our experience with Tier 1 and Tier 2 performance goals increased, we continued our efforts to improve the efficiency and consistency of the review processes and ultimately, performance.
As an indication of FDA’s commitment to improving the predictability, consistency, and transparency of our premarket programs, we have taken or are 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.
We believe the actions that we have taken and plan to take in the future will have a positive impact on the device review process. With the enactment of the Medical Device User Fee Amendments of 2012 reauthorizing medical device user fees for FY 2013 through FY 2017, FDA looks forward to another five years of cooperative efforts for increasing the timely availability of safe and effective new medical devices to patients and health care providers.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs