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 |
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 |
Updated April 16, 2007
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