2024 FDA 年度注冊費7653$， 無優(yōu)惠和減免， 510（K）技術(shù)審評費 小規(guī)模5440$, 相比2023 分別遞增17.87% 和9.52%！

2023 FDA 年度注冊費6493$， 無優(yōu)惠和減免， 510（K）技術(shù)審評費 小規(guī)模4967$，相比2022 分別遞增14.47% 和55.90%！

2022 FDA 年度注冊費5672$， 無優(yōu)惠和減免， 510（K）技術(shù)審評費 小規(guī)模3186$

兩個費用，年年遞增，需要申請美國FDA醫(yī)療器械產(chǎn)品注冊和備案和朋友，請聯(lián)系深圳市思博達彭先生或登錄公司網(wǎng)站www.bccgd.com。

贈送510K電子遞交申報格式部分內(nèi)容供參考，更多更詳細(xì)的請聯(lián)系深圳市思博達彭先生或登錄公司網(wǎng)站www.bccgd.com。

Structure of the current eSTAR 510(k) Electronic Submission Template

1、Submission Type

Identification of key information that may be useful to FDA in the initial processing and review of the 510(k) submission, including content from current Form FDA 3514, Section A.

2、Cover Letter / Letters of Reference

Attach a cover letter and any documents that refer to other submissions.

3、Submitter Information

Information on submitter and correspondent, if applicable, consistent with content from current Form FDA 3514, Sections B and C.

4、Pre-Submission Correspondence & Previous Regulator Interaction

Information on prior submissions for the same device included in the current submission, such as submission numbers for a prior not substantially e (NSE) determination, prior deleted or withdrawn 510(k), , Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE) application, or De Novo classification request.