Establishment of Medical Device User Fee Rates for Fiscal Year 2004

摘要

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2004. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes FDA to collect user fees for certain medical device applications. The FY 2004 fee rates are provided in this notice. For all applications submitted on or after October 1, 2003, and through September 30, 2004, fees must be paid at the FY 2004 rates at the time that applications are submitted to FDA. It is the date that the application is received by FDA, not the date that the check is received, that governs the fee that must be paid. This notice provides details on how fees for FY 2004 were determined and payment procedures for those submitting medical device applications subject to user fees.