|
|
FY 2009 Device Review User Fees (U.S. Dollars)
$ F1 d. C& D8 o& f& \% @- p
2 J( X+ E' V, B& x G5 B" `510(k) :9 O9 P. c7 a! O) p) M
Application Standard Fee
1 q4 A$ ~; N& D9 C5 Z8 t9 h+ ^$ I$3,693+ `% f* n: w- q ?0 O
" V, ^' M1 S) B! {0 }$ K: N% z
Small Business (≤$100 million in
7 H3 r8 r G& e# pgross receipts or sales) Fee
* r7 t1 m; h$ j3 v0 d) M# L% d$1,8474 [2 V6 h* O- Y5 D* S, t- a6 O$ v6 Y
2 H2 A6 c& {/ l% @: a1 D2 V
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 ,3 Q0 T; J. G0 t" {
0 h. E$ R& A+ B1 x5 N1 H! T/ ]! m) J t" K7 u0 M a
FY 2009 Establishment Registration Fee is $1,851 U.S. Dollars,
+ x8 U$ y% P( e, ^0 G, \* ~+ m以前注册不用钱.
" I! z3 e+ C; |
- B) U0 M; j9 D1 }
. A2 o5 i% N1 `2 l* e1 Q以上费用为2009 年最新费用,FDA会适时调整收费标准 |
|