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FY 2009 Device Review User Fees (U.S. Dollars) 9 d* e5 G4 ^# v6 A4 [5 M( f
$ ^" e( S ^9 A4 g510(k) :/ Z/ Z8 o( c& E6 j- K3 Y
Application Standard Fee
2 X/ s$ `0 ]2 e' e) ?. k$3,693
9 g/ D6 o: G: ?9 k2 | : C! |2 l6 C, }1 z) R
Small Business (≤$100 million in
z* W" z/ Z2 f5 agross receipts or sales) Fee& z w' N0 K! I- c
$1,847* ?4 c. ~) W/ w# A$ ?( V1 G
% O5 M7 T" @! {0 m2 j) J/ S
如果你符合 small business 资格认定标准,又有很多 510k 要申请,强烈建议去申请 small business ,
# E1 h7 Z# \) _( ~8 ~8 c
2 \' X: M6 D. }
" {5 a% E8 o3 G) I$ o, K# \1 BFY 2009 Establishment Registration Fee is $1,851 U.S. Dollars,$ u0 C* L. e6 Z
以前注册不用钱.) m4 o) \* Z$ @5 k! w
! B9 X) _* X2 W; |6 Z$ c. Z/ J; Y
6 I# i' F' P: M; b _" w% z7 q% M以上费用为2009 年最新费用,FDA会适时调整收费标准 |
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