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FY 2009 Device Review User Fees (U.S. Dollars) ( l6 u. u9 N" H N/ I4 p4 y9 M
% _% O+ z/ ]7 y U! k510(k) :6 @- z& _* ?* @1 {" i. M' H3 x6 B
Application Standard Fee1 }6 k4 O" F! H8 p
$3,693
' V; A0 I* w0 t* p t/ n* ^" c% t x( q) [$ K
Small Business (≤$100 million in( ~+ F/ l5 [9 q9 k* ~* v. s W
gross receipts or sales) Fee
3 `, r# f* G) b$ ^" i w0 k2 l$1,847
4 d/ l5 ?& h5 A; h0 ?- z+ V, B
5 C- f+ w5 T5 Y- D/ W+ X# c# f: p- O如果你符合 small business 资格认定标准,又有很多 510k 要申请,强烈建议去申请 small business ,
6 |+ D/ o, q3 ^" `9 q8 Q' t0 I7 c$ D* E& D& b6 [
6 _4 e; `6 w! c
FY 2009 Establishment Registration Fee is $1,851 U.S. Dollars,9 ~# Q0 t# `" n6 S
以前注册不用钱.
. [% Y5 _4 z( F' o$ p H
2 |1 M8 n4 Z0 @9 Y& W2 p
' n! h. f1 R' p+ s; q% C7 G' u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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