申請(qǐng)類型 | 對(duì)應(yīng)情況 | 標(biāo)準(zhǔn)收費(fèi)金額 | 小規(guī)模公司（收入總額或銷售額小于1億美元）收費(fèi)金額 |
上市前批準(zhǔn) 包括PMA、PDP、PMR、BLA申請(qǐng) | ① | 236,298美元 | 59,075美元 |
小組追蹤PMA補(bǔ)充申請(qǐng) | ② | 177,224美元 | 44,306美元 |
180天PMA補(bǔ)充申請(qǐng) | ③ | 35,445美元 | 8,861美元 |
實(shí)時(shí)PMA補(bǔ)充申請(qǐng) | ④ | 16,541美元 | 4,135美元 |
上市前通告（510K）申請(qǐng) | 4,348美元 | 2,174美元 | |
III類產(chǎn)品周期性報(bào)告 | 8,270美元/年 | 2,068美元/年 | |
機(jī)構(gòu)注冊 | 2,179美元 | ||
由CDRH出具的出口證明（CFG） | 對(duì)由同一個(gè)生產(chǎn)企業(yè)在同一生產(chǎn)場所生產(chǎn)的一個(gè)或多個(gè)產(chǎn)品申請(qǐng)CFG：正本175美元，每申請(qǐng)1個(gè)副本加收15美元（包括與正本同時(shí)申請(qǐng)或得到正本后的補(bǔ)充申請(qǐng)） | ||
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))
-
服務(wù)流程資料添加中....
- 官方收費(fèi)資料添加中....
- 基礎(chǔ)法規(guī)資料添加中....
- 相關(guān)服務(wù)資料添加中....
全國服務(wù)熱線：
