n95口罩出口美国eua申请注意事项

n95口罩出口美国eua申请办理，美国地区为了规范口罩的进口，在疫情期间给出了更优的认证方案，提出了EUA申请办理。

对于n95口罩申请EUA备案的事项可以联系我司咨询，以上递交资料适用于本来就已经生产医疗器械、但口罩尚未在美国境内上市的制造商。有两点是需要注意的：

1、FDA只是减免了510（k）技术文档要求，但关于产品测试，生产车间质量体系的要求是从未有放弃的；

2、在新冠肺炎疫情爆发期间内，FDA不拘泥于任何区域的产品标准，只要你是做相关产品测试，欧盟的、中国的，都可以将测试报告递交，由FDA决定是否可以授予紧急授权。

FDA也欢迎非医疗器械企业生产销售医疗器械，可以粗暴理解成就是连生产车间QSR820都未外审过的制造商，至于要怎么操作，发邮件问FDA。

额外要求

FDA对于紧急授权下的口罩产品，有如下要求：

Appropriate conditions designed to ensure that health careprofessionals administering the device are informed—

that FDA has authorized the emergency use of the device;

of the significant known and potential benefits and risks of theemergency use of the device, and of the extent to which suchbenefit and risks are unknown;

of the alternatives to the device that are available, and oftheir benefits and risks.

Appropriate conditions designed to ensure that individuals towhom the device is administered are informed—

that FDA has authorized the emergency

of the option to accept or refuse administration of the device,of the consequence,if any, of refusing administration of thedevice, and of the alternatives to the device that are availableand of their benefits and risks.