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"Medical Device User Fee and Modernization Act of 2002

The FDA will begin issuing invoices for fees payable for medial device applications submitted between October 1, 2002 and September 30, 2003.  The FDA will not actually begin collecting these fees until the enabling appropriations are enacted.  The fees will be due and payable within 30 days after the date of the Federal Register notice that the enabling appropriations have been enacted.

The basic fee structure will be $154,000 for the premarket application (PMA).  All other fees are set as a percent of this fee.  For example, the small business fee would be $58,520 ( 80% of a full application fee).

On Oct. 9, the House of Representatives passed HR 3580, the "Medical Device User Fee and Modernization Act of 2002," which hopefully will speed FDA approval of new devices by instituting a system of manufacturer user fees to help cover the costs of the agency's premarket reviews. Passage came on a roll-call vote of 406 to 3.

The FDA would raise $150 million over the next five years through the new user fee program.

Among other provisions, HR 3580 establishes FDA performance goals, third-party inspections for Class II and Class III devices and new labeling for reprocessed single-use devices.

On October 26, 2002  President Bush announced that he was signing HR 5651 that day.  The “Medical Device User Fee and Modernization Act of 2002”, initiates a system of manufacturer user fees.  These fees are to be paid by the manufacturers upon application to the FDA for approval of their new product(s).

 

These fees will be used to off set the expenses the FDA has incurred with the ever increasing volume of new medical technologies they are being asked to approve.  The FDA will use these fees to “afford more expert staff to conduct thorough reviews within reasonable time limits”, with the aim of “faster approval of lifesaving innovations.”