FDA

FDA

         根据美国联邦食品、药品与化妆品法律(Food ， Drug and Cosmetic Act) 的规定，任何人应当在美国市场销售医疗器械之前的90 天，向美国食品药品监督管理局(FDA) 递交510(k)申请，除非该器械的申请途径为入市前许可(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，所有与销往美国产品相关的企业，包括但不仅限于，生产商，合约生产商，灭菌站，进出口公司等，都需要根据21 CFR part807 的要求向FDA 进行工厂注册(Establishment Registration) 以及医疗器械列示(Medical Device Listing); 所高美国海外的企业还需要同时告知FDA 其在美国境内的美国代理入(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.

我们的服务

Services

◆ 策略咨询

 Pre-submission strategy consulting

◆ 根据产品的特点， 确定合适的对比器械

 Determine appropriate predicate device per your product features

◆ 协助制定整体解决方案

 Establish submission plan based on our experience

◆ 建立测试方案，提供测试服务，或推荐合适的检测机构

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

◆ 协助准备510(k) 文件所需的各类相关信息

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

◆ 编写510(k) 文件

 Complete the 51 O(k) submission documents

◆ 代表您与指定的审核机构进行沟通

 Communicate with the designated review party

◆ 协助完成工厂注册和医疗器械列示

 Complete Establishment Registration and Medical Device Listing

◆ 提供美国代理人服务

 Act as your U.S. Agent

此外，我们还可以根据FDA 的要求，

建立临床方案、软件确认方案、可用性测试方案，并根据您的产品和企业情况提供针对性培训

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.

体系文件(融入21 CFR PART 820)编制、辅导、审核

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

FDA技术服务流程

Service for FDA