哪些企业需要进行FDA的企业注册 从下图可以看出，在美国本土外的器械制造商，器械出口商，分包制造商，分包灭菌服务提供方，器械设计开发者以及器械的再加工，再生产和再贴牌的厂家都需要进行企业注册并且需要按照FDA的要求缴纳年金。
SUNGO TECHNICAL SERVICE LLC是美国的专门从事法规技术服务的集团公司，在英国注册为SUNGO GROUP COMPNAY LIMITED，在中国注册为上海沙格企业管理咨询有限公司。SUNGO集团凭借网络和队伍为客户提供法规性服务，在器械行业尤为专长。 选择SUNGO，不是选择了一次性的合作伙伴，而是选择了一个长期的技术支持的战略伙伴。 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
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）
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 requested 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.