Medical Device User Fees and User Fee Acts

Erin D. Williams
Specialist in Public Health and Bioethics

The Food and Drug Administration (FDA) is the agency responsible for ensuring the safety and effectiveness of medical devices. An establishment may not market a device in the United States without FDA's prior approval or clearance. 

In 2002, Congress first granted FDA the authority to collect user fees from medical device establishments. The authority was granted to help reduce the time required for the agency to review and make decisions about marketing applications. Lengthy review times harmed establishments, which waited to market devices, and patients, who waited to use them. User fee law provides a revenue stream for the agency, and also requires it to set performance goals for rapid application review. 

The authority to collect medical device user fees has been authorized in five-year increments, and will expire next on October 1, 2012. In 2002, it was first established in the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250). Before reauthorization, it was amended by the Medical Device Technical Corrections Act (P.L. 108-214) and the Medical Device User Fee Stabilization Act of 2005 (P.L. 109-43). It has been reauthorized once, in the Medical Device User Fee Amendments of 2007 (MDUFA 2007), enacted as Title II of the Food and Drug Administration Amendments Act of 2007 (H.R. 3580; P.L. 110-85). 

Since medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA's device budget. In FY2003, $14.8 million of user fees comprised 6.8% of the budget. In FY2007 (the year of the most recent reauthorization), $35.2 million of user fees comprised 13.2% of the budget. 

Medical device user fees have raised a number of issues. These have prompted Congress to determine the following: which activities should require fees; how user fees can be kept from supplanting federal funding, or being diverted from device review (through triggers); which activities the agency should fund with user fees; and how to qualify as a small business. (Small businesses pay reduced fee amounts.) 

In addition to addressing the above issues, medical device user fee legislation has served a secondary purpose as a moving vehicle that legislators could use to address a range of issues related to medical devices. For example, MDUFA 2007 included provisions about the extent to which FDA can delegate activities to third parties (inspections and the review of premarket notifications); establishment registration requirements (timing and electronic submission); a unique device identification system; reporting requirements for devices linked to serious injuries or deaths; and requirements that FDA and GAO conduct certain studies. MDUFMA included provisions about reprocessed single use devices and other topics. 

This report provides an overview of FDA and the medical device review process. It then presents the legislative history of user fees. Next, it explains the basics of FDA's medical device user fee system, noting the way in which various provisions have evolved. Finally, it provides an overview of non-user fee issues addressed in the device user fee acts.


Date of Report: April 26, 2010
Number of Pages: 33
Order Number: RL34571
Price: $29.95

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