sungo的fda验厂优势 1） 团队具备多年500强美资企业的法规工作经验； 2） 具有成功包括新华集团在内的近百家企业通过fda审核的经验； 3） 具有成功fda提前五天通知的飞行检查的经验； 4） 咨询师具有的语言能力，担任陪审和翻译的任务会使得企业应对更轻松。 提供fda美国代理人服务，产品美国fda注册，化妆品fda注册、食品fda注册，fda验厂、陪审和翻译
选择了sungo作为美代的您可以享受到如下星级服务： 1. fda注册的日常维持，更新； 2. fda新动态的时间告知及建议； 3. 随时为您提供与fda注册和上市后监管等相关的事务的处理意见； 4.可代表您回答您美国客户的相关fda问题（英文邮件，英文电话会议均可）； 5.接受fda验厂时，以优惠的价格提供qsr820、审核经验传授及全程英语陪审 6.选择有能力进行qsr820（包括美国法规知识、国内审核经验和英语沟通能力）的美国代理人！ 7.在完成注册后，启动qsr820体系，按照美国法规的要求实施管理，有备无患！ 8.实在没有满足第2条又被抽查到，立即联系我们，为你提供五天方案审查！
510(k)审查程序 fda在收到企业递交的510(k)资料后，先检查资料是否，如资料，则受理并给企业发出确认性，同时给出申请受理编号(k yyxxxx)，此号码也将作为正式批准后的号码;如不，则要求企业在规定时间内补充，否则作企业放弃处理。fda在受理申请后即进入内部工作程序，其中可能还会要求企业补充一些资料。在510(k)申请通过审阅后，fda并不立即发出批准函件，而是根据产品风险等级、市场先前是否对企业有不良反 映等确定是否对企业进行现场gmp考核，考核通过后再发给企业正式批准函件(clearance);如无须现场考核gmp，则510(k)申请通过后立即发给正式批准函件。
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).
fda对于美国代理人的解释也可以参考看一下网站的原文： any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the united states must identify a united states agent (u.s. agent) for that establishment. information about a foreign establishment’s u.s. agent is submitted electronically using the fda unified registration and listing system (furls system) and is part of the establishment registration process. each foreign establishment may designate only one u.s. agent. the foreign establishment may also, but is not required to, designate its u.s. agent as its official correspondent. the foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the u.s. agent. the u.s. agent identified will be required to complete an automated process to confirm that they have agreed to act as the u.s. agent. the automated process will forward an email verification request to the u.s. agent. they will be re to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. if the u.s. agent denies consent (or does not respond within 10 business days), the official correspondent/owner operator of the foreign establishment will be notified and must designate a new u.s. agent to satisfy the regulatory obligation.
FDA510K
