上海随缘企业登记1. 现在有针对中国KN95型口罩的EUA申请★，FDA在短期内快速审核口罩的资料★。并在关网上公布获得EUA授权的企业和产品型号★！相当于发一个简易临时的合格证替代NIOSH认证★，
2、范围是中国生产的一次性防护型口罩★，就是立体的那种★。医用平面口罩不算在内★！
在FDA的指导里面写明★，可以申请EUA的目前有两种机构:一是实验室★。可以申请EUA获得检测允许;第二种就是医疗器械公司★！有研发制造能力的可以申请EUA★，给器械获取紧急时期的使用资格★。
4、根据FDA文件★，中国生产的口罩获得EUA授权★。需要满足三个要求：★！
一是拥有一个或多个NIOSH(美国国家职业安全卫生研究所)认证产品的制造商★，按照其他国家/地区的适用授权标准生产的其他型号的过滤式面罩呼吸器(FFR)★。FDA可以进行验证；★！
二是中国以外的其他地区授权的★，FDA可以进行验证；★。
三是有独立的测试实验室出具的检测报告★，能显示其产品性能符合适用的测试标的★。FDA可以进行验证★！
这其中最容易满足的应该是第3个条件★，注意：
（EUA）有效期：这个授权仅在爆发期间有效★，FDA认为结束的时候该EUA就会失效★。疫情结束后需要重新做NIOSH认证★！
未在美国境内的上市的医疗用途的外科口罩、N95口罩★，不管是美国境内还是境外制造商★。都可以申请紧急授权★！需要递交以下资料★，并发送到FDA 这个邮箱：CDRH-COVID19-SurgicalMasks@fda.hhs.gov★。由FDA审核是否可以授予紧急授权★！让该产品在新冠疫情期间在美国境内销售★，
1、General information such as your contact information★，name and place of business★。email address★！and contact information for a U.S. agent (if any) in addition to generalinformation about the device such as the proprietary or brand name★，model number★。and marketing authorization in your country (or region).★！
2、copy of the product labeling.★，
3、Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number★，if available).★。
4、Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO13485: Medical Devices ?C Quality Management Systems ?C Requirements forRegulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such.★，
5、Description of testing conducted on the device★，including any standards met★。such as
★！6、liquid barrier protection★，flammability★。biocompatibility★！and filtration performance★，asappropriate. For surgical N95 respirators★。FDA recommends including fluid resistance testing (liquid barrier performance).★！
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★！
此外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★，
FDA对于紧急授权下的口罩产品★，有如下要求：
已有74家中国生产企业获EUA★。想出口美国的赶紧申请★！_随缘企登
★，Appropriate conditions designed to ensure that health care professionals 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 the emergency use of the device★，and of the extent to which such benefit and risks are unknown;★。
of the alternatives to the device that are available★，and of their benefits and risks.★。
Appropriate conditions designed to ensure that individuals to whom the device is administered are informed―★，
that FDA has authorized the emergency★，
of the significant known and potential benefits and risks of the emergency use of the device★，and of the extent to which such benefit and risks are unknown;★。
of the option to accept or refuse administration of the device★，of the consequence★。if any★！of refusing administration of the device★，and of the alternatives to the device that are available and of their benefits and risks.★。
获得EUA授权的口罩★，要在包装标识上明确这是FDA紧急授权的产品★。
