Medical Device Importers Can Expect Decrease In FDA Fees for 2012, According to FDAImports.com

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While fees are increasing for many industries importing to the United States, the medical device industry can expect to pay less next year due to instruction from Congress, according to FDAImports.com

In fiscal years 2008, 2009, 2010, and 2011 (expected), FDA collected more fees than Congress appropriated for FDA to collect – $18 million more.

Most FDA-regulated industries are bracing to pay more in fees in the coming months, but not the medical device industry, which received happy news when FDA recently announced the user fees for fiscal year 2012, according to FDAImports.com.

In fiscal years 2008, 2009, 2010, and 2011 (expected), FDA collected more fees than Congress appropriated for FDA to collect – $18 million more. Therefore, Congress mandated that FDA credit this excess back to the industry by decreasing the fees for F.Y. 2012, which was originally established in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

For example, the medical device industry paid $2,179 in fiscal year 2011 for an annual device registration. According to MDUFMA, the medical device industry expected to pay $2,364, but will actually end up paying $2,029. This is welcome news as most importers and manufacturers are preparing for new fees, larger costs and associated examination expenses. By contrast, food importers are preparing for a substantial uptick in costs and fees for imports, mostly in regard to shipments with a potential food safety issue and the new structure FDA has put in place to examine and approve them.

Sources:
1. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm266885.htm
2. 76 Fed. Reg. 45826 (Aug. 1, 2011).
3. 76 Fed. Reg. 45826, 45827
4. http://www.fdaimports.com/coalition.php

Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Currently he is founder and CEO of FDAImports.com, LLC, a firm of consultants and affiliated attorneys practicing at the intersections of complex administrative law and regulations that impact international traders in highly regulated commodities.

For more information contact Benjamin L. England and the FDAImports.com team at http://www.fdaimports.com, call (410) 740-3403 or contact Jon Barnes at jrbarnes(at)fdaimports(dot)com.

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