Zdrowie i gospodarka · 25.02.2003

Medical Device User Fee Payment Procedures

The Food and Drug Administration (FDA) is announcing the payment procedures for medical device user fees for fiscal year (FY) 2003. 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 2003 fee rates were published in the Federal Register of November 21, 2002 (67 FR 70228 at 70229, as amended by the Federal Registers of January 10, 2003, and January 22, 2003 (68 FR 1469 and 68 FR 3033)); however, FDA could not begin to collect these fees until enabling appropriations were enacted. Those enabling appropriations were enacted on February 20, 2003, so FDA is now able to collect Medical Device User Fees for FY 2003. Accordingly, FDA will issue invoices for all fees payable for applications submitted between October 1, 2002, and March 31, 2003. Those invoices will be due and payable within 30 days of issuance. For all applications submitted on or after April 1, 2003, fees must be paid at the time that applications are submitted to FDA. This notice provides payment procedures for those submitting medical device applications th