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美國FDA 2011財務(wù)年度的醫(yī)療器械收費狀況

美國 FDA 于2010年8月3日頒布了2011財務(wù)年度的醫(yī)療器械收費狀況，如下表

申請類型	對應(yīng)情況	標(biāo)準(zhǔn)收費金額	小規(guī)模公司（收入總額或銷售額小于1億美元）收費金額
上市前批準(zhǔn) 包括PMA、PDP、PMR、BLA申請	①	236,298美元	59,075美元
小組追蹤PMA補充申請	②	177,224美元	44,306美元
180天PMA補充申請	③	35,445美元	8,861美元
實時PMA補充申請	④	16,541美元	4,135美元
上市前通告（510K）申請		4,348美元	2,174美元
III類產(chǎn)品周期性報告		8,270美元/年	2,068美元/年
機構(gòu)注冊		2,179美元
由CDRH出具的出口證明（CFG）		對由同一個生產(chǎn)企業(yè)在同一生產(chǎn)場所生產(chǎn)的一個或多個產(chǎn)品申請CFG：正本175美元，每申請1個副本加收15美元（包括與正本同時申請或得到正本后的補充申請）

具體以下面英文為主：

Table 1.--Medical Device Fees for FY 2011
----------------------------------------------------------------------------------------------------------------
Standard Fee, as a
Percent of the Standard FY 2011 Small
Application Fee Type Fee for a Premarket FY 2011 Standard Fee Business Fee
Application
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Set in Statute $236,298 $59,075
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 under section 100% $236,298 $59,075
515(c)(2) of the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an approved BLA under 100% $236,298 $59,075
section 351 of the PHS Act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement 75% $177,224 $44,306
----------------------------------------------------------------------------------------------------------------
180-day supplement 15% $35,445 $8,861
----------------------------------------------------------------------------------------------------------------
Real-time supplement 7% $16,541 $4,135
----------------------------------------------------------------------------------------------------------------
510(k) premarket notification submission 1.84% $4,348 $2,174
----------------------------------------------------------------------------------------------------------------
30-day notice 1.6% $3,781 $1,890
----------------------------------------------------------------------------------------------------------------
513(g) request for classification information 1.35% $3,190 $1,595
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class 3.5% $8,270 $2,068
III device
----------------------------------------------------------------------------------------------------------------
Annual establishment registration fee (to be Set in Statute $2,179 $2,179
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))