{
  "id": "RL33981",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL33981",
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      "id": 348280,
      "date": "2007-07-12",
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      "title": "Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization",
      "summary": "Unless Congress acts to reauthorize it, the Food and Drug Administration\u2019s (FDA\u2019s) authority to collect user fees under the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250) and, by reference, FDA\u2019s obligation to meet related performance goals, will expire on October 1, 2007. According to the President\u2019s 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\u2019s 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.\nFor MDUFMA as passed in 2002, 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, 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.\nThe 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\u2019s initiatives related to the regulation of in vitro diagnostic devices (laboratory tests). (MDUFMA enabled third-party inspections and set standards for the use of reprocessed single-use devices.) The details of the proposed reauthorization of MDUFMA have been incorporated, with a few exceptions, into the Medical Device User Fee Amendments of 2007 (MDUFA 2007). On May 9, 2007, MDUFA 2007 passed the Senate as Title III of the Food and Drug Administration Revitalization Act (S. 1082). On July 11, 2007, the House passed it as Title II of the Food and Drug Administration Amendments Act of 2007 (H.R. 2900). The bills\u2019 MDUFA 2007 provisions are similar, but not identical. Differences between them are expected to be addressed in conference. The provisions of MDUFMA and the proposals for MDUFA 2007 are discussed in this report, following an introduction to FDA\u2019s medical device review process.\nThis report will be updated as event warrant.",
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      "source": "University of North Texas Libraries Government Documents Department",
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      "id": "RL33981_2007May11",
      "date": "2007-05-11",
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      "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc819859/",
      "id": "RL33981_2007Apr30",
      "date": "2007-04-30",
      "retrieved": "2016-03-19T13:57:26",
      "title": "Medical Device User Fee and Modernization Act (MDUFMA) Reauthorization",
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