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FY 2016 MDUFA Performance Report

Commissioner’s Report

I am pleased to present the Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2016 Performance Report to Congress for the Medical Device User Fee Amendments (MDUFA).  The enactment of the third authorization of MDUFA in 2012 (MDUFA III) reauthorized medical device user fees for 5 additional years (FY 2013 through FY 2017).  This is the fourteenth report on medical device user fee review performance, and the fourth report to reflect the more challenging goals set under MDUFA III.

Reauthorization of the medical device user fee program has helped to expedite the availability of innovative new products to market by boosting the Agency’s medical devices regulatory review capacity through hiring new staff. MDUFA III represents a commitment between the U.S. medical device industry and FDA to increase the efficiency of regulatory processes in order to reduce the total time it takes to make decisions on safe and effective medical devices.

FDA’s performance continued to be strong during FY 2016, the fourth year of MDUFA III. Preliminary data for performance goals through September 30, 2016, including completed and pending reviews, indicate that FDA has met, or has the potential to meet, all 18 of the performance goals for which FDA received submissions in FY 2016. In FY 2015, FDA is currently exceeding all of 18 performance goals on which actions have been taken. With 73 submissions still pending within the MDUFA III goal date, representing 1 percent of the total cohort, FDA has the potential to meet or exceed all applicable performance goals for FY 2015. The steps FDA is taking to continue to improve predictability, consistency, and transparency in the device review process are listed on FDA’s website.

We believe the actions that FDA has taken and plans to take under MDUFA III will have a positive impact on the device review process. These completed and planned actions demonstrate our continued commitment to strengthening our medical device review programs, providing predictable device review processes, and increasing the efficiency with which medical devices are developed and made available to patients.

Robert M. Califf, M.D.
Commissioner of Food and Drugs

Printable version of the FY 2016 MDUFA Performance Report