FDA收费价格(2017年10月1日)生效
申请类型 |
标准收费标准 |
小企业收费标准 |
510(K) | $10,566 | $2,642 |
513(g) | $4,195 | $2,098 |
De Novo classification | $93,229 | $23,307 |
PMA,PDP,PMR,BLA | $310,764 | $77,691 |
Panel-track supplement | $233,073 | $58,268 |
180-day supplement | $46,615 | $11,654 |
Real-time supplement | $21,753 | $5,438 |
BLA efficacy supplement | $310,764 | $77,691 |
PMA annual report | $10,877 | $2,719 |
30-day notice | $4,972 | $2,486 |