Regulatory Focus™ > News Articles > MDUFA Goals Met in 74-85% of Cases in 2012, FDA Report Says

MDUFA Goals Met in 74-85% of Cases in 2012, FDA Report Says

Posted 08 March 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new congressional report it wrote regarding its performance under the final fiscal year of the Medical Device User Fee Act (MDUFA), a law intended to help the agency access more funding in return for meeting more stringent timelines for the review of medical devices.

The second iteration of the act, MDUFA II, was passed in 2007 under the Food and Drug Administration Amendments Act (FDAAA), and contains numerous application-type specific goals for the agency to meet each year.

Those goals are broken down into two "tiers," with Tier 1 performance goals focused on speed, and Tier 2 performance goals focused on overall review completion rates.

While the goals and expectations vary by the type of application submitted, they are intended to make sure that FDA clears a majority of the applications quickly (Tier 1 goals, 60-180 days), and the remainder within a slightly longer period (Tier 2 goals, 90-210 days).

Report on Overall Performance

The report notes that FDA has generally met those goals over the five-year MDUFA II term, though not in all cases. In 2012, for example, it met, exceeded or "has the potential to meet" its Tier 1 goals in 23 out of the 27 categories (85%) and 20 of 27 Tier 2 goals (74%).

The "potential to meet" category is based on submissions that may still be pending beyond the calendar year, but have not yet exceeded a goal in terms of FDA review days, which are treated differently than calendar review days for the purposes of MDUFA II goals.

Some application types fare better than others when it comes to FDA meeting its review goals. For Tier 1 products, just 70% of PMA modules and 34% of expedited original PMAs were reviewed on time. Similar trends held through second-tier goals, with just 85% of PMA modules and 67% of expedited original PMAs meeting their goals.

Nearly 100% of all other products in both Tiers met their review times, however, including 510(k) applications, which boasted an impressive 99.9% on-time percentage in Tier 2, and a 97% in Tier 1. FDA said it missed just two applications within its 150-day decision goal for 510(k) premarket notification submissions.

The agency also touted its development of new guidance documents that were committed to during the MDUFA II negotiation process. Nine of those documents were released in the 2012 fiscal year, including ones detailing its acceptance policies for 510(k) and premarket approval applications (PMAs), the pre-submission program, the appeals process for its device division, early feasibility studies, and the de novo process.


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