FDA

         根據(jù)美國聯(lián)邦食品、藥品與化妝品法律(Food ， Drug and Cosmetic Act) 的規(guī)定，任何人應當在美國市場銷售醫(yī)療器械之前的90 天，向美國食品藥品監(jiān)督管理局(FDA) 遞交510(k)申請，除非該器械的申請途徑為入市前許可(Premarket Approval, PMA) 或者510(k) 豁免。

         According to Federal Food, Drug, and Cosmetic Act, each person must submit a premarket notification submission to the Food and Drug Administration (FDA) at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution 01 a device, unless the submission type of the device is Premarket Approval (PMA) or 510(k) exempt.

           此外，所有與銷往美國產品相關的企業(yè)，包括但不僅限于，生產商，合約生產商，滅菌站，進出口公司等，都需要根據(jù)21 CFR part807 的要求向FDA 進行工廠注冊(Establishment Registration) 以及醫(yī)療器械列示(Medical Device Listing); 所高美國海外的企業(yè)還需要同時告知FDA 其在美國境內的美國代理入(U.S. Agent) 。

            In addition, all the related firms, including but not limited to manufacture， contract manufacturer, contract sterilizer, importer and exporter and etc, are required to complete Establishment Registration and Medical Device Listing per 21 CFR part 807. AII foreign firms shall appoint a U.S. Agent during the establishment registration.

我們的服務

Services

◆ 策略咨詢

 Pre-submission strategy consulting

◆ 根據(jù)產品的特點， 確定合適的對比器械

 Determine appropriate predicate device per your product features

◆ 協(xié)助制定整體解決方案

 Establish submission plan based on our experience

◆ 建立測試方案，提供測試服務，或推薦合適的檢測機構

 Establish test plan, provide testing service, or recommend test laboratories

◆ 協(xié)助準備510(k) 文件所需的各類相關信息

 Assist you in preparing the information required by 510(k)

◆ 編寫510(k) 文件

 Complete the 51 O(k) submission documents

◆ 代表您與指定的審核機構進行溝通

 Communicate with the designated review party

◆ 協(xié)助完成工廠注冊和醫(yī)療器械列示

 Complete Establishment Registration and Medical Device Listing

◆ 提供美國代理人服務

 Act as your U.S. Agent

此外，我們還可以根據(jù)FDA 的要求，

建立臨床方案、軟件確認方案、可用性測試方案，并根據(jù)您的產品和企業(yè)情況提供針對性培訓

Furthermore, we have capabilities to assist you in establishing clinical protocol, software validation protocol, usability/human factor testing plan according to the FDA requirements , and provide targeted training based on your product and business situation.

體系文件(融入21 CFR PART 820)編制、輔導、審核

Compile QMS documents（covering 21 CFR Part 820 requirements） ,guide and audit

FDA技術服務流程

Service for FDA