FDAClass II
510(k) 上市前通知
510(k) Premarket Notification
$26,0676–12个月
医疗器械
FDAClass III
PMA 上市前批准
Premarket Approval (PMA)
$579,27218–36个月
医疗器械
FDAClass I / Class II (new)
De Novo 分类申请
De Novo Classification Request
$173,78212–24个月
医疗器械体外诊断
FDAClass II
510(k) IVD 上市前通知
510(k) for IVD
$26,0678–14个月
体外诊断
FDAClass III
PMA 高风险 IVD
PMA for High-Risk IVD
$579,27224–42个月
体外诊断
FDA
NDA 新药申请
New Drug Application (NDA)
$4,488,83060–120个月
药品
FDA
505(b)(2) 新药申请
505(b)(2) NDA
$4,488,83024–60个月
药品
FDA
ANDA 仿制药申请
Abbreviated New Drug Application (ANDA)
$243,90518–36个月
药品
FDA
BLA 生物制品许可申请
Biologics License Application (BLA)
$4,488,83072–144个月
生物制品
FDA
351(k) 生物类似药申请
Biosimilar Application (351(k))
$438,84348–96个月
生物制品
FDA
MoCRA 化妆品合规
MoCRA Cosmetic Compliance
$01–3个月
化妆品
FDA
膳食补充剂合规（DSHEA）
Dietary Supplement Compliance (DSHEA)
$02–6个月
保健品中药