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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 app

 
Our Price: $15.00
By Randall B. Williamson (au)
Year: 2007
Pages: 13
Binding Paperback

Product Code: 1422315614

Description
 
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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