新疆喜乐彩走势图

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格慧泰福(GHTF)新疆喜乐彩走势图 | 高端医疗器械临床注册专家

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新疆喜乐彩走势图

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美国FDA 2011财务年度的医疗器械收费状况
 美国 FDA 于2010年8月3日颁布了2011财务年度的医疗器械收费状况,如下表

SHENQINGLEIXING

DUIYINGQINGKUANG

BIAOZHUNSHOUFEIJINE

新疆喜乐彩走势图XIAOGUIMOGONGSI(SHOURUZONGEHUOXIAOSHOUEXIAOYU1YIMEIYUAN)SHOUFEIJINE

SHANGSHIQIANPIZHUN

BAOKUOPMA、PDP、PMR、BLASHENQING

236,298MEIYUAN

59,075MEIYUAN

新疆喜乐彩走势图XIAOZUZHUIZONGPMABUCHONGSHENQING

177,224MEIYUAN

44,306MEIYUAN

180TIANPMABUCHONGSHENQING

35,445MEIYUAN

8,861MEIYUAN

SHISHIPMABUCHONGSHENQING

16,541MEIYUAN

4,135MEIYUAN

新疆喜乐彩走势图SHANGSHIQIANTONGGAO(510K)SHENQING

4,348MEIYUAN

2,174MEIYUAN

IIILEICHANPINZHOUQIXINGBAOGAO

8,270MEIYUAN/NIAN

2,068MEIYUAN/NIAN

JIGOUZHUCE

2,179MEIYUAN

新疆喜乐彩走势图YOUCDRHCHUJUDECHUKOUZHENGMING(CFG)

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JUTIYIXIAMIANYINGWENWEIZHU:

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))

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    美国FDA 2011财务年度的医疗器械收费状况

    美国FDA公布2014财年医疗器械FDA注册收费

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