U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Medical Device User Fee Amendments (MDUFA)
  5. Comparison of Quantitative Decision Goals in MDUFMA I and II
  1. Medical Device User Fee Amendments (MDUFA)

Comparison of Quantitative Decision Goals in MDUFMA I and II

MDUFMA IMDUFMA II
PMA and Panel Track Supplements
50% of PMAs and panel track PMA supplements in 180 days60% of PMAs and panel track PMA supplements in 180 days
90% of PMAs, panel-track supplements, premarket reports in 320 days90% of PMAs and panel track PMA supplements in 295 days
NA50% of expedited PMAs and expedited panel track PMA supplements in 180 days
90% of expedited PMAs in 300 days90% of expedited PMAs and expedited panel track PMA supplements in 280 days
Modular PMA
NA75% of PMA modules in 90 days
NA90% of PMA modules in 120 days
510 (k)s
80% of 510(k)s in 90 days90% of 510(k)s in 90 days
NA98% of 510(k)s in 150 days
180-Day PMA Supplements
90% of 180-Day PMA supplements in 180 days85% of 180-Day PMA supplements in 180 days
95% of 180-Day PMA supplements in 210 days
Real-Time PMA Supplements
NA80% of Real-Time PMA Supplements in 60 days
90% of Real-Time PMA Supplements in 90 days
BLAs
90% of BLAs in 10 monthsSame as MDUFMA I
90% of BLA supplements in 10 months
90% of BLA resubmissions and BLA supplement resubmissions in 2 months

Proposed Industry User Fee Schedule for MDUFMA II

Fees Structure2007 Fees & RelationshipsBase YearFee Amounts for 2009-2012
200720082009201020112012
FeeFeeFeeFeeFeeFee
Full PMA/BLA Fee$ 281,600$ 185,000$ 200,725$ 217,787$ 236,298$ 256,384
Small Businesses Making Above Submissions$ 107,008$ 46,250$ 50,181$ 54,447$ 59,075$ 64,096
Full Fee for Panel Track Supplements$ 281,600$ 138,750$ 150,544$ 163,340$ 177,224$ 192,288
Small Businesses Making Above Submissions$ 107,008$ 34,688$ 37,636$ 40,835$ 44,306$ 48,072
180-Day Supplements Full Fee$ 60,544$ 27,750$ 30,109$ 32,668$ 35,445$ 38,458
Small Businesses Paying Above Fee$ 23,007$ 6,938$ 7,527$ 8,167$ 8,861$ 9,614
Real Time Supplements Full Fee$ 20,275$ 12,950$ 14,051$ 15,245$ 16,541$ 17,947
Small Businesses Paying Above Fee$ 7,705$ 3,237$ 3,512$ 3,810$ 4,134$ 4,485
510k Fee$ 4,158$ 3,404$ 3,693$ 4,007$ 4,348$ 4,717
Small Businesses Paying Above Fee$ 3,326$ 1,702$ 1,847$ 2,004$ 2,174$ 2,359
30-Day Notice Fee $ 2,960$ 3,212$ 3,485$ 3,781$ 4,102
Small Businesses Paying Above Fee$ 1,480$ 1,606$ 1,742$ 1,890$ 2,051
513(g) fee$ 2,498$ 2,710$ 2,940$ 3,190$ 3,461
Small Businesses Paying Above Fee$ 1,249$ 1,355$ 1,470$ 1,595$ 1,731
Device Registration Fee$ 1,706$ 1,851$ 2,008$ 2,179$ 2,364
Annual Report Filing Fee$ 6,475$ 7,025$ 7,623$ 8,270$ 8,973
Small Businesses Making Above Submissions$ 1,619$ 1,756$ 1,906$ 2,068$ 2,243