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U.S. Department of Health and Human Services

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MDUFA Performance Reports

 
On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which included the reauthorization and expansion of MDUFA for 5 additional years (FY 2013 through FY 2017, referred to as MDUFA III). MDUFA III addresses many of the priorities and concerns identified by public stakeholders and the device industry and many of the important challenges identified by FDA.
 
MDUFA I to MDUFA III
 
Since the implementation of MDUFA I in 2002, MDUFA I allowed FDA to better serve the public health by providing additional funds to FDA for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met
 
  • MDUFMA I (FY 2003 through FY 2007). On October 26, 2002, MDUFMA I was signed into law. MDUFMA I amended the FD&C Act authorizing FDA to collect fees from companies that submit certain applications for marketing of medical devices. In return, MDUFMA I required FDA to pursue a comprehensive set of device review performance goals that were intended to significantly improve the timeliness and predictability of FDA’s review of new devices. A limited number of performance goals were applied during FY 2003 and FY 2004, allowing FDA time to hire staff, build infrastructure, provide guidance to industry, and take other actions. Consequently, most of the substantive review performance goals went into effect in FY 2005. Additional performance goals were added in FY 2006 and again in FY 2007, with the goals becoming more challenging each year. On April 1, 2004, MDUFMA I was amended and expanded by the Medical Device Technical Corrections Act (MDTCA), Public Law (P.L.) 108-214. MDTCA amended MDUFMA I to clarify Congress’ intent and to improve and expand upon some features of MDUFMA I. On August 1, 2005, the Medical Device User Fee Stabilization Act of 2005 (the “Stabilization Act”), P.L. 109-43, amended provisions of the FD&C Act relating to medical device user fees and device labeling; however, neither the changes made by MDTCA nor those made by the Stabilization Act affected the performance goals FDA pursued under MDUFMA I. 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. Final performance for MDUFMA I decision goal cohorts was reported in the FY 2009 MDUFA Performance Report to Congress.
 
  • MDUFA II (FY 2008 through FY 2012). On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007 (FDAAA), which included MDUFA II. MDUFA II reauthorized medical device user fees and identified new performance goals for FY 2008 through FY 2012. MDUFA II committed FDA to meeting new medical device premarket review performance goals, which were defined in the HHS Commitment Letter (see Appendix A). The new performance goals focused on FDA MDUFA decisions, because FDA decisions are so strongly linked to the final approval or clearance of new devices. These performance goals were agreed to by industry and were a key part of the negotiated package of user fees and other legislative changes made by MDUFA II.  MDUFA II increased the focus on making a timely decision, as defined for each type of MDUFA-related application. Under this approach, each performance goal consists of two tiers, each with a distinct review time (number of days) and performance level (percentage of submissions on time). Tier 1 performance goals focus on completing a specified proportion of reviews within shorter time frames as compared to performance goals that existed under MDUFMA I. Tier 2 performance goals focus on completing a larger proportion of reviews within somewhat longer time frames that were established under MDUFA II. MDUFA II required 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 10th annual medical device user fee performance report to Congress and presents FDA’s progress in achieving user fee performance goals.
 
  • MDUFA III (FY 2013 through FY 2017). Some of the changes to MDUFA III include improvements to the review process, infrastructure, and, capacity enhancements. MDUFA III introduced more rigorous review performance goals and shared outcome goals. Enhanced metrics for improvements to the premarket review process were provided for in MDUFA III. MDUFA III will fund about a third of the total cost of the medical device premarket review process.

 

For additional information on these reports, please contact:

Office of Planning
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
Phone: 301-796-4850
FAX: 301-847-3541