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MDUFA II (FY 2008 through FY 2012)

FY 2009 MDUFA Performance Report Table of Contents

On September 27, 2007, the President signed FDAAA that included MDUFA II. MDUFA II reauthorized medical device user fees and identified new performance goals for FY 2008 through FY 2012.[4] MDUFA II committed FDA to meeting new premarket review performance goals, which are defined in the HHS Commitment Letter (see Appendix A). The new performance goals focus on FDA decisions, because FDA decisions are so strongly linked to the final approval or clearance of new devices. These performance goals were developed with input from industry and were a key part of the negotiated package of user fees and other changes made by MDUFA II. 
 
In addition to reauthorizing FDA to collect user fees for medical device applications, MDUFA II requires FDA to meet rigorous goals for reviewing medical devices that build on the progress of MDUFMA I. These goals are intended to achieve progressive, year-by-year improvements in review processes for medical devices. The majority of devices associated with MDUFA II are reviewed by the Center for Devices and Radiological Health (CDRH). However, a number of devices that are critical to ensuring the safety, purity, and potency of biologic products, including assuring the safety of our Nation’s supply of blood and human tissue products, are reviewed by the Center for Biologics Evaluation and Research (CBER). CBER also regulates diagnostic tests for retroviruses, including human immunodeficiency virus, as well as devices used in cell and gene therapies. An Intercenter Agreement between CBER and CDRH describes the types of devices regulated by CBER and is available at: Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health
 
MDUFA II requires the HHS Secretary to submit two annual reports to Congress: 1) a performance report and 2) a financial report that are both due within 120 days of the end of the fiscal year. This report is FDA’s seventh annual performance report and presents FDA’s progress in achieving user fee performance goals and additional commitments through FY 2009. The current and past performance and financial reports are available at: MDUFMA Reports.  

During FY 2008 and FY 2009, FDA continued to work to meet MDUFMA I decision goals for submissions received in FY 2003 through FY 2007. However, FDA no longer applies, tracks, or reports on MDUFMA I first-action and subsequent-action cycle goals.
 

[4] Title II of FDAAA, P.L. 110-85 (September 27, 2007).