Comparison of Quantitative Decision Goals in MDUFMA I and 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

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