	Overview: FDA and Medical Device Review

In order to understand the significance of MDUFMA, a basic introduction to FDA and the medical device review process is useful. The agreement specified that, in return for the additional resources provided by medical device user fees, FDA was expected to meet performance goals defined in a November 14, 2002 letter from the Secretary of the Department of Health and Human Services (HHS) to the Chairman and Ranking Minority Members of the Committee on Health, Education, Labor and Pensions Committee of the U.S. Senate and the Committee on Energy and Commerce of the U.S. House of Representative. FDA's authority for the first of these (the collection of user fees) will expire on October 1, 2007, unless Congress reauthorizes it. Pursuant to MDUFMA (§105), on April 30, 2007, FDA held a public meeting about the FDA Agreement. The terms of the FDA Agreement were, by and large, incorporated into the Food and Drug Administration Revitalization Act ( S. 1082 ), which the Senate passed on May 9, 2007. They have also been generally incorporated into the Food and Drug Administration Amendments Act of 2007 ( H.R. 2900 ), which the House passed on July 11, 2007. The two bills' MDUFA 2007 provisions are similar, but not identical, as explained below. Differences are expected to be addressed in conference. Like MDUFMA, MDUFA 2007 proposals address both user fee authorities and third-party inspection. User Fees

Several important aspects of MDUFMA and MDUFA 2007 are related to user fees, including statutory "triggers" that link FDA's authority to collect and spend user fees to levels of Congressional appropriations, as well as reductions and exemptions to fees, performance goals, and allowable uses of fees. According to the President's FY2008 budget request, MDUFMA fees would translate into 200 FTEs for that year, or 13% of the FTEs in the device review process (See Table 5 ). Under authority created by the Food and Drug Administration Modernization Act ( P.L. Small Businesses . MDUFA 2007 would change the third-party accredited person inspection program in three major areas. According to FDA, MDUFMA focused on premarket review activities, largely limiting FDA's use of MDUFMA funds to this area, and focusing all performance goals on it as well. S. 1082 contains no parallel provision in the medical device user fee title. This pilot would include only voluntary participants from industry, and the applications involved in the pilot would not be counted toward the MDUFA 2007 performance goals; Consider industry proposals on acceptable CLIA waiver study protocols, develop acceptable protocol designs, and make them available by adding appendices to the guidance or by posting redacted protocols on the Office of In Vitro Diagnostic Device (OIVD) website; Track and report FDA performance on CLIA waiver applications and share this information with industry annually and then evaluate, at the end of year two, whether user fees and performance goals for CLIA waivers should be considered for MDUFA 2007I; Review an industry-provided list of Class I and II low risk IVD devices to determine if any could be exempted from premarket notification and allow interested parties to petition for exemptions consistent with 510(m)(2) [provisions exempting certain devices from 510(k) premarket notification requirements]; and Conduct a review of the pre-IDE program to address issues raised by industry. Acronyms Used in This Report
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, 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.
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 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' 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's medical device review process.
This report will be updated as event warrant.