FDA began collecting MDUFMA user fees for each premarket application, premarket report, supplement, or 510(k) submitted on or after October 1, 2002, unless the establishment is eligible for a waiver or exception. If you submitted an application between October 1, 2002 and March 30, 2003, FDA did not require you to submit payment at the same time you submitted your application; instead, FDA will send you an invoice for the fee for the application you submitted during that period. You must pay your invoice by the due date printed on the invoice. Beginning April 1, 2003, you must pay your fee before FDA will file your application. If you do not pay the appropriate fee, FDA will not review your application and you will not be able to market your device. | 
