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。
出口美国的企业需要建立QSR820体系 QSR820的定义 QSR是质量体系法规的简写，820实际指的是CFR 21 PART 820部分，是FDA法规中对于器械质量管理体系的相关要求。QSR820不是孤立的要求，其要求与PART 803，PART 807等其他部分都紧密相关。QSR820和ISO13485的要求有部分类似，但又有明显的差异。 FDA对QSR820的监控方式 FDA像CFDA一样在发放许可证之前行体系考核。FDA对于所有的企业的体系考核是通过后续的抽查形式来进行监控的，的器械注册企业都会有被抽查到的可能性。风险越高的器械的生产企业被抽查到的概率越高。通常抽查会提前两个月通知被检查的企业，也有部分是提前一周才通知的。
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.
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）