Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

Delay in publication of Medical Device User Fees for Fiscal Year 2006

The FDA on August 1, 2005 announced that there would be a delay in publishing the user fee it would be assessing for medical device applications for fiscal year 2006.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorized FDA to collect user fees for medical device applications in exchange of expediting the approval process. However, the act also specifies that the FDA can change the fee in FY 2006 and FY 2007 only if the total amounts appropriated for FY 2003 through FY 2005 are not less than the levels specified in MDUFMA. As it turns out, FDA collections for the device and radiological health program have been less than the mandated levels and hence FDA would be unable to assess a user fee in FY 2006 for medical device applications. This holds true unless additional legislation is enacted that overrules or modifies the above requirement. The FDA is delaying making any announcement for the time being, however, if any legislation is enacted that allows the agency to collect the fee, the FDA would, in the next 2 weeks from the date of announcement, announce the applicable fees for FY 2006.

For more information on the FDA User Fees contact the FDA at www.FDA.gov/cdrh/dsma or mdi at Userfees@mdiconsultants.com.

If any questions on the report or comments please email us at info@mdiconsultants.com.

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map