发布时间：2009-08-21
FDA公布2010财政年度(2009.10.1-2010.09.30) 财政年度医疗器械收费案
2010年医疗器械制造商年费变更为USD2008, 从2009年10月开始到12月底止，FDA将征收所有注册制造商的2010年年费；
其他收费具体参加下表：
Table 1.--Medical Device Fees for FY 2010
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Standard Fee, as a Percent
Application Fee Type of the Standard Fee for a FY 2010 Standard Fee FY 2010 Small Business Fee
Premarket Application
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Annual establishment (2010年度制造商年费) Set in statute $2,008 $2,008
registration fee (to be paid
by each establishment that
is a manufacturer, a single-
use device reprocessor, or a
specification developer, as
defined by 21 U.S.C.
379i(13))
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510(k) premarket notification 1.84% $4,007 $2,004
Submission (510K审核费)
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Premarket application (a PMA Set in statute $217,787 $54,447
submitted under section
515(c)(1) of the act (21
U.S.C. 360e(c)(1)), a PDP
submitted under section
515(f) of the Act, or a BLA
submitted under section 351
of the Public Health Service
(PHS) Act (42 U.S.C. 262))
----------------------------------------------------------------------------------------------------------------
Premarket report (submitted 100% $217,787 $54,447
under section 515(c)(2) of
the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an 100% $217,787 $54,447
approved BLA under section
351 of the PHS Act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement 75% $163,340 $40,835
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180-day supplement 15% $32,668 $8,167
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Real-time supplement 7% $15,245 $3,811
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30-day notice 1.6% $3,485 $1,742
----------------------------------------------------------------------------------------------------------------
513(g) (21 U.S.C.
request for classification
information
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Annual Fee Type ..........................
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Annual fee for periodic 3.5% $7,623 $1,906
reporting on a class III
device
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