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Brendon Nafziger, DOTmed News Associate Editor | September 01, 2009
Anticipated fee
hikes quantified
The FDA is raising user fees for most medical equipment companies, according to guidelines printed in the Federal Register (Aug. 3).
As previously reported by DOTmed Business News, the fees are set to go up for 2008-2012 following passage of the Medical Device User and Modernization Act of 2002 (MDUFMA), as well as amendments in 2005 and 2007.
The so-called standard fee, the fee by which most payments are determined, has increased to $217,787 for the 2010 fiscal year, which begins Oct. 1, 2009.
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The fee increase applies to most companies that manufacture, develop and sterilize medical devices, as well as to those that re-process single-use equipment. The costs of both annually registering companies and applying for FDA approval on devices have increased.
Source:
Federal Register
Get all the details from FDA:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm
