Application Type 应用类型 |
Standard Fee | Small Business Fee† 小企业收费 |
Medical device manufacturer control fees 医疗器械制造商管制费 |
$7653 | $7653(No reduction or exemption/无减免) |
510(k) 510K审核费 | $21760 | $5440 |
513(g) 513g审核费 | $6528 | $3264 |
PMA, PDP, PMR, BLA 上市前批准,申报审核费 | $483560 | $120890 |
De Novo Classification Request,De Novo分类请求审查验收收费 | $145068 | $36267 |
Panel-track Supplement 信息补充收费 | $386848 | $96712 |
180-Day Supplement 180天信息补充收费 | $72534 | $18134 |
Real-Time Supplement 实时补充收费 | $33849 | $8462 |
BLA Efficacy Supplement BLA有效性补充收费 | $483560 | $120890 |
30-Day Notice 30天通知收费 | $7737 | $3869 |
Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) III类设备定期报告的年费(PMA、PDP和PMR) | $16925 | $4231 |
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