The FDA Medical Device User Fee Program (CRS Report for Congress)
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| Release Date |
Revised Feb. 6, 2013 |
| Report Number |
R42508 |
| Report Type |
Report |
| Authors |
Judith A. Johnson, Specialist in Biomedical Policy |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
The Food and Drug Administration (FDA) is the agency responsible for the regulation of medical devices. These are a wide range of products that are used to diagnose, treat, monitor, or prevent a disease or condition in a patient. A medical device company must obtain FDA's prior approval or clearance before marketing many medical devices in the United States. The Center for Devices and Radiological Health (CDRH) within FDA is primarily responsible for medical device review and regulation. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers), which together comprises FDA's total.
Congress first gave FDA the authority to collect user fees from medical device companies in the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). Five years later, the user fees were reauthorized through September 30, 2012, by the Medical Device User Fee Amendments of 2007 (MDUFA II; Title II of the Food and Drug Administration Amendments Act of 2007, FDAAA; P.L. 110-85). Over the years, concerns raised about medical device user fees have prompted Congress to carefully consider issues such as which agency activities could use fees, how user fees can be kept from supplanting federal funding, and which companies should qualify as small businesses and pay a reduced fee.
The purpose of the user fee program is to help reduce the time in which FDA can review and make decisions on marketing applications. Lengthy review times affect the industry, which waits to market its products, and patients, who wait to use these products. The user fee law provides a revenue stream for FDA; in conjunction, the agency negotiates with industry to set performance goals for the premarket review of medical devices. In February 2012, FDA reached agreement with the medical device industry on proposed recommendations for the second user fee reauthorizationâreferred to as MDUFA III. The draft MDUFA III packageâcomposed of statutory language and the FDA-industry agreement on performance goals and proceduresâwas posted on the FDA website in March 2012. Following a public meeting and a 30-day comment period on the draft, a final MDUFA III recommendation was submitted to Congress.
On July 9, 2012, the FDA Safety and Innovation Act (FDASIA, P.L. 112-144) became law. MDUFA III was included in FDASIA as Title II. FDA's authority to collect medical device user fees was reauthorized for another five years, FY2013 through FY2017. FDASIA also reauthorized the prescription drug user fee program, created new user fee programs for generic and biosimilar drug approvals, and modified FDA authority to regulate medical products.
However, under the current FY2013 continuing resolution (P.L. 112-175), although FDA is collecting the new user fees allowed by MDUFA III/FDASIA, it can only spend fees up to the FY2012 level. Since medical device user fees were first collected in FY2003, they have comprised an increasing proportion of FDA's device budget. All user fees (as enacted) accounted for 35% of FDA's total FY2012 program level, and device user fees accounted for 14% of the device and radiological health program level, which was $376 million in FY2012, including $53 million in user fees.
