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U.S. Department of Health and Human Services

Medical Devices

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Comparison of Quantitative Decision Goals in MDUFMA I and II

MDUFMA I MDUFMA II
PMA and Panel Track Supplements
50% of PMAs and panel track PMA supplements in 180 days 60% of PMAs and panel track PMA supplements in 180 days
90% of PMAs, panel-track supplements, premarket reports in 320 days 90% of PMAs and panel track PMA supplements in 295 days
NA 50% of expedited PMAs and expedited panel track PMA supplements in 180 days
90% of expedited PMAs in 300 days 90% of expedited PMAs and expedited panel track PMA supplements in 280 days
Modular PMA
NA 75% of PMA modules in 90 days
NA 90% of PMA modules in 120 days
510 (k)s
80% of 510(k)s in 90 days 90% of 510(k)s in 90 days
NA 98% of 510(k)s in 150 days
180-Day PMA Supplements
90% of 180-Day PMA supplements in 180 days 85% of 180-Day PMA supplements in 180 days
95% of 180-Day PMA supplements in 210 days
Real-Time PMA Supplements
NA 80% of Real-Time PMA Supplements in 60 days
90% of Real-Time PMA Supplements in 90 days
BLAs
90% of BLAs in 10 months Same 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 Structure

 

 

2007 Fees & Relationships

Base Year

Fee Amounts for 2009-2012

2007

2008

2009

2010

2011

2012

Fee

Fee

Fee

Fee

Fee

Fee

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