Medical Devices

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

 

Page Last Updated: 04/02/2015
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