Under MDUFMA II, fee rates for PMA and BLA fees and for annual establishment registration are set in the statute. The rates for all other fees are statutorily set as a percent of the full PMA fee rate. The premarket report fee and the efficacy supplement fee are equal to the PMA fee. The panel track supplement fee is 75 percent of the PMA fee. The 180-day supplement fee is 15 percent of the PMA fee. The real-time supplement fee is seven percent of the PMA Fee. The 30-day notice fee is 1.6 percent of the PMA fee. The premarket notification submission (510(k)) fee is 1.84 percent of the PMA fee. The request for classification information (513(g)) fee is 1.35 percent of the PMA fee and the fee for periodic reporting concerning class III devices is 3.5 percent of the PMA fee. Qualified small businesses (an entity that reported $30,000,000 or less in gross receipts or sales in its most recent Federal income tax return) pay 25 percent of the specified fee, except that for premarket notifications (510(k)s), 30-day notices, and requests for classification they pay 50 percent of the specified rate. There is no small business rate for annual establishment registrations. Table 10 exhibits the rates for all types in FY 2009 (Second year of MDUFMA II) and FY 2010 (Third year of MDUFMA II).  

 

 

 

 

 

Table 11 summarizes the number of applications/fees received by FDA in each year,FY 2008 through FY 2010, for which the fees had been paid in full by the companies before September 30.