Medical Device User Fee Amendments 2012 (MDUFA III)

The Food and Drug Administration Safety and Innovation Act (Public Law 112-144) includes the Medical Device User Fee Amendments of 2012, or MDUFA III. MDUFA III will take effect on October 1, 2012 and will sunset in five years on October 1, 2017.

Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions.

Ultimately, MDUFA III represents a commitment between the U.S. medical device industry and the FDA to increase the efficiency of regulatory processes in order to reduce the time it takes to bring safe and effective medical devices to the U.S. market.

MDUFA III is the result of more than a year of public input, negotiations with industry representatives, and discussions with patient and consumer representatives. Under MDUFA III, the FDA is authorized to collect user fees that will total approximately $595 million (plus adjustments for inflation) over five years. With this additional funding, the FDA will be able to hire more than 200 full-time-equivalent workers over the course of MDUFA III.

In exchange, the FDA has committed to meet certain performance goals outlined in the Secretary of Health and Human Service’s letter to Congress (the MDUFA III commitment letter).