申請類型 | 對應情況 | 標準收費金額 | 小規模公(gong)司（收入(ru)總額(e)(e)或銷售額(e)(e)小于1億美元）收費金額(e)(e) |
上市前批準 包括(kuo)PMA、PDP、PMR、BLA申(shen)請 | ① | 236,298美元 | 59,075美元 |
小(xiao)組追(zhui)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(tong)告（510K）申請(qing) | 4,348美元 | 2,174美元 | |
III類產品周期性報告(gao) | 8,270美元/年 | 2,068美元/年 | |
機構注冊 | 2,179美元 | ||
由CDRH出(chu)(chu)具的出(chu)(chu)口證明（CFG） | 對由同一個(ge)(ge)生(sheng)產企業在(zai)同一生(sheng)產場(chang)所生(sheng)產的一個(ge)(ge)或多個(ge)(ge)產品申請(qing)CFG：正(zheng)本175美(mei)元，每申請(qing)1個(ge)(ge)副本加收15美(mei)元（包(bao)括與正(zheng)本同時申請(qing)或得到正(zheng)本后的補充申請(qing)） | ||
具(ju)體以下(xia)面(mian)英文(wen)為(wei)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))
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