Food and Drug Administration: Revenue Information on Certain Companies Participating in the Medical Device User Fee Program
The Food & Drug Amin. (FDA) is responsible for approving medical devices -- such as catheters & artificial hearts -- to provide reasonable assurance of their safety & effectiveness. Congress enacted the Medical Device User Fee & Modernization Act of 2002 (MDUFMA) which authorizes FDA to charge user fees for some device applications & not others. In FY2005, FDA collected $31 million in user fees from device applications. This report provides revenue information for: (1) companies that qualified as small businesses under the MDUFMA user fee program in FY2006; & (2) companies publicly traded in the U.S. that submitted device applications subject to user fees & did not qualify as small businesses under MDUFMA in FY2006. Charts.
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258 publicly traded 4,500 applications subject accepted accounting principles afﬁliate Analytics and Mergent annual revenue information approved device approximately 4,500 applications assessed the reliability Audit Analytics database BLA Efficacy Supplements businesses in ﬁscal companies submitted companies that qualiﬁed companies that submitted companies were responsible Development Protocol PDP device applications subject Enclosure FDA data FDA in ﬁscal Federal Food federal income tax fee waiver ﬁled with SEC ﬁnancial statement ﬁled ﬁscal year 2006 GAO’s Government Accountability Ofﬁce gross sales income tax returns MDUFMA user fee names and addresses obtained annual revenues ofﬁcials parent ﬁrm percent Premarket Notiﬁcation Premarket Report pretax ﬁnancial income private data vendors program in ﬁscal provide annual revenues publicly traded companies qualiﬁed small businesses qualify as small reliability of FDA Request for approval revenues above $30 sales or receipts small business qualiﬁcation standard user fee subject to user submitted device applications submitted to FDA threshold for small user fee program
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Page 10 - Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health;" "Intercenter Agreement Between the Center for Devices and Radiological Health and the Center for Biologies Evaluation and Research;" "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Biologies Evaluation and Research.
Page 4 - CDRH reviews applications for the majority of these devices, such as artificial hearts, dialysis machines, and radiological devices. CBER reviews applications for devices used in the testing and manufacture of biological products, including diagnostic tests intended to screen blood donors (such as for the human immunodeficiency virus), as well as therapeutic devices used in cell and gene therapies. FDA also inspects manufacturers' establishments to assess compliance with good manufacturing practices...
Page 5 - Request for approval of a device that supports or sustains human life, is of substantial importance in preventing impairment of human health, or which...
Page 4 - DOD officials reviewed a draft of this report and provided technical comments, which we incorporated where appropriate.
Page 9 - To provide annual revenues for the 697 companies that qualified as small businesses under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA...
Page 4 - It also contains proposed labeling for the device and, when applicable, clinical and nonclinical studies that provide reasonable assurance of the device's safety and effectiveness.