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GAO-07-882R 1 (2007-06-25)

handle is hein.gao/gaocrptavlo0001 and id is 1 raw text is: Sai Accountability * Integrity * Reliability United States Government Accountability Office Washington, DC 20548 June 25, 2007 The Honorable Joe Barton Ranking Member Committee on Energy and Commerce House of Representatives Subject: Food and Drug Administration: Methodologies for Identifying and Allocating Costs of Reviewing Medical Device Applications Are Consistent with Federal Cost Accounting Standards, and Staffing Levels for Reviews Have Generally Increased in Recent Years Dear Mr. Barton: The Food and Drug Administration (FDA) is the agency responsible for ensuring the safety and effectiveness of medical devices-such as catheters and artificial hearts-marketed in the United States. As part of its regulatory responsibilities, FDA reviews applications submitted by medical device companies for devices they wish to market, including devices that are new or those that include modifications to already approved devices. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)' authorized FDA, beginning in fiscal year 2003, to charge user fees for various types of device applications. User fees were intended to provide resources to FDA, to increase staffing for medical device reviews and speed the timeliness of reviews, in addition to resources otherwise provided through the annual appropriations process. Under MDUFMA, FDA is required to report to the congressional committees of jurisdiction annually on the implementation of the user fee program. FDA submitted financial reports that include information such as amounts collected from user fees, the costs of reviewing device applications, and staffing levels FDA dedicated to the review of medical device applications for each fiscal year from 2003 through 2005.2 In response to industry concerns about the need for more cost information, FDA supplemented these MDUFMA financial reports by reporting 'Pub. L. No. 107-250, 116 Stat. 1588. 2Department of Health and Human Services, Food and Drug Administration, FY 2003 MDUFMA Financial Report: Required by the Medical Device User Fee and Modernization Act of 2002 (Washington, D.C., March 2004); FY2004 MDUFMA Financial Report: Required by the Medical Device User Fee and Modernization Act of 2002 (Washington, D.C., March 2005); FY 2005 MDUFMA Financial Report: Required by the Medical Device User Fee and Modernization Act of 2002 (Washington, D.C., July 2006). GAO-07-882R Medical Device Review

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