Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization

Publication Date: April 2007

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health

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Abstract:

Unless Congress acts to reauthorize it, the Food and Drug Administration's (FDA's) authority to collect user fees under the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250) and, by reference, FDA's obligation to meet related performance goals, will expire on October 1, 2007. According to the President's budget request, in FY2008, funds from a reauthorized MDUFMA would account for an estimated $47.5 million and 200 full-time equivalent employees (FTEs). This would comprise 16.6% of FDA's medical device review budget authority and 13.0% of its medical device review-related FTEs. While these numbers and percentages are not as high as those projected for collection under a similar FDA user fee authority related to prescription drugs (pursuant to the Prescription Drug User Fee Act), they are significant.

For MDUFMA as passed in 2002 ("MDUFMA I"), the fee amounts and performance goals articulated and incorporated in statute were the result of an agreement between FDA and the medical device industry. In order to facilitate the reauthorization of MDUFMA ("MDUFMA II") in April 2007, the FDA and industry published the results of their negotiations with a notice of an April 30, 2007, public meeting on the topic. According to FDA, during the five years covered by the proposals (through 2012), FDA would receive approximately $287 million from user fees. This represents an increase from the $110 million FDA received during the first four years of the program.

The industry agreement also calls for changes in the fee structure, performance goals, small business relief, and third party inspection program. In addition, the agreement reflects FDA's initiatives related to the regulation of in vitro diagnostic devices (laboratory tests). (MDUFMA I enabled third party inspections and set standards for the use of reprocessed single-use devices.) The details of the proposed MDUFMA II provisions have been incorporated into Senator Kennedy's bill, the Food and Drug Administration Revitalization Act as reported out of the Senate Health, Education, Labor, and Pensions Committee (S. 1082). The details of MDUFMA I and these proposals for MDUFMA II are discussed in this report, following an introduction to FDA's medical device review process.

This report will be updated as needed.