Release Time：2021-04-25
2020年7月31日，FDA公布2021财年医疗器械评审最新收费情况。
以下是FDA官方发布的2021财年FDA医疗器械评审收费表：
申请类型 | 标准收费 | 小企业收费 |
510(k) | $12,432 | $3,108 |
513g | $4,936 | $2,468 |
De Novo classification | $109,697 | $27,424 |
PMA, PDP, PMR, BLA | $365,657 | $91,414 |
panel-track supplement | $274,243 | $68,561 |
180-day supplement | $54,849 | $13,712 |
real-time supplement | $25,596 | $6,399 |
BLA efficacy supplement | $365,657 | $91,414 |
PMA annual report | $12,798 | $3,200 |
30-day notice | $5,851 | $2,926 |
Annual Establishment Registration Fee | $5,546 | |
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