申请美国的FDA510K流程怎么做? 器械FDA 510(k)注册,因其相应FD&C Act第510章节,故通常称510(K)注册。510(k)为器械在美国上市的主要途径之一,绝大多数的II类器械和部分I类、III类器械通过此途径清关上市。对510(k)注册文件所必须包含的信息,FDA有一个基本的要求,其内容大致如下16个方面: 1) 申请函,此部分应包括申请人(或联系人)和企业的基本信息、510(K)递交的目的、申请上市器械的名称型号和分类资料、进行实质等效比较的产品(Predicate Device)名称及其510(k)号码; 2) 目录,即510(k)文件中所含全部资料的清单(包括附件); 3) 真实性保证声明,对此声明,FDA有一个标准的样本; 4) 器材名称,即产品通用名、FDA分类名、产品贸易名; 5) 注册号码,如企业在递交510(k)时已进行企业注册,则应给出注册信息,若未注册,也予注明; 6) 分类,即产品的分类组、类别、管理号和产品代码; 7) 性能标准,产品所满足的强制性标准或自愿性标准; 8) 产品标识,包括企业包装标识、使用说明书、包装附件、产品标示等; 9) 实质相等性比较(SE); 10) 510(k)摘要或声明; 11) 产品描述,包括产品的预期用途、工作原理、动力来源、零组件、照片、工艺图、装配图、结构示意图等; 12) 产品的安全性与有效性,包括设计、测试资料; 13) 生物相容性; 14) 色素添加剂(如适用); 15) 软件验证(如适用); 16) 灭菌(如适用),包括灭菌方法的描述、灭菌验证产品包装和标识等。 FDA510K 流程 实质相等性比较(SE) 实质相等性比较是要证明所申请上市的产品和已在美国市场上合法销售的产品在安全性和有效性方面比较是实质相等的。选择合适的产品进行比较是510(K)申请的关键步骤。在进行比较时应从如下方面进行考虑: 企业必须提供充足的资料证明,所申请上市的器械和被比较的器械是实质相等的(SE),否则510(k)申请通过。
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FDA 化妆品注册怎么做? FDA化妆品注册(138电181话046微17信) • 1/ 化妆品企业注册可以在出口美国之前或者出口之后(30天内); • 2/ 化妆品产品注册需要有1000美金的出口之后,但是实际上FDA无法核对; • 3/ Can I file formulations in the VCRP for products that are considered drugs but also have a cosmetic function? 对于药品有化妆品功能的是否可以做化妆品注册? • Yes, products that are considered drugs in the United States, such as sunscreens, but also make cosmetic type claims, such as moisturizing, can be filed in the VCRP. • 4/ 可以进行化妆品注册,但是这并不能豁免其需要同时满足药品的相关要求的职责。
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Responsibilities of a U.S. agent The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours. The responsibilities of the U.S. agent are limited and include: assisting FDA in communications with the foreign establishment, responding to concerning the foreign establishment's devices that are imported or offered for import into the United States, assisting FDA in scheduling inspections of the foreign establishment and if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be e to providing the same information or documents to the foreign establishment. Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).
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QSR820审核的可能的结果 NAI(审核无483直接通过) VAI(审核有483,是一般不符合) OAI(审核有483,是严重不符合) Warning Letter 警告信(企业必须在规定期限回复,有可能需要再次审核进行验证) Import Alert 进口禁令(企业产品到美国海关会被自动扣留,进入DWPE程序)