费用类型

标准收费

小企业收费

FY2024

FY2025

升/降

FY2024

FY2025

升/降

510(k) premarket notification submission

$21,760

$24,335

11.84%

$5,440

$6,084

11.84%

Premarket  application

$483,560

$540,783

11.84%

$120,890

$135,196

11.84%

Panel-track  supplement

$386,848

$432,626

11.84%

$96,712

$108,157

11.84%

De  novo classification request

$145,068

$162,235

11.84%

$36,267

$40,559

11.84%

180-day  supplement

$72,534

$81,117

11.84%

$18,134

$20,279

11.84%

Real-time  supplement

$33,849

$37,855

11.84%

$8,462

$9,464

11.84%

30-day  notice

$7,737

$8,653

11.84%

$3,869

$4,326

11.84%

513(g)  request for classification information

$6,528

$7,301

11.84%

$3,264

$3,650

11.84%

Annual  Fee for Periodic Reporting on a Class III device

$16,925

$18,927

11.84%

$4,231

$4,732

11.84%

Annual Establishment Registration Fee

$7,653

$9,280

21.25%

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