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GAO-07-571R 1 (2007-03-30)

handle is hein.gao/gaocrptavbt0001 and id is 1 raw text is: Sai Accountability * Integrity * Reliability United States Government Accountability Office Washington, DC 20548 March 30, 2007 The Honorable Joe Barton Ranking Minority Member Committee on Energy and Commerce House of Representatives Subject: Food and Drug Administration: Revenue Information on Certain Companies Participating in the Medical Device User Fee Program Dear Mr. Barton: The Food and Drug Administration (FDA) is responsible for approving medical devices- such as catheters and artificial hearts-to provide reasonable assurance of their safety and effectiveness. As part of this responsibility, FDA, an agency within the Department of Health and Human Services (HHS), reviews applications submitted by medical device companies for devices they wish to market in the United States, including devices that are new or those that constitute modifications to already approved devices. Prior to 2002, members of Congress, representatives of the medical device industry, and others expressed concern that FDA lacked the resources necessary to complete such reviews in a timely manner to ensure that patients have access to useful, possibly life-saving, devices. In response, Congress enacted the Medical Device User Fee and Modernization Act of 2002 (MDUFMA),' which authorizes FDA to charge user fees for some device applications and not others. Revenues from the user fees, together with additional appropriations that were also authorized by MDUFMA, were intended to provide additional resources to FDA for improving the timeliness of device review. In fiscal year 2005, FDA collected approximately $31 million in user fees from device applications. Under the MDUFMA user fee program, fees for individual medical device applications range from under $5,000 to more than $250,000.2 Higher fees are charged for applications that require more review. One of the applications with a higher user fee-$259,600 in fiscal year 2006-is the Original Premarket Approval (PMA) application. A PMA is submitted for a device that supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. One of the applications with a lower user fee-$3,833 in fiscal year 2006-is a Premarket Notification. A Premarket Notification is submitted for devices that are substantially equivalent to a legally marketed device that was not subject to premarket approval. 'Pub. L. No. 107-250, 116 Stat. 1588. 2MDUFMA includes provisions for user fee amounts for fiscal years 2006 and 2007. GAO-07-571R Financial Information on Device Companies

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