kn95口罩EUA备案申请办理事项

kn95口罩EUA备案申请办理，kn95口罩产品eua备案申请注意事项，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gicalMasks@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。

资料如下：

1、General information such as your contact information, name andplace of business,email address, and contact information for a U.S.agent (if any) in addition to generalinformation about the devicesuch as the proprietary or brand name, model number,and marketingauthorization in your country (or region).

2、copy of the product labeling.

3、Whether the device currently has marketing authorization inanother regulatory jurisdiction (including certification number, ifavailable).

4、Whether the device is manufactured in compliance with 21 CFRPart 820 or ISO13485: Medical Devices – Quality Management Systems– Requirements forRegulatory Purposes or an equivalent qualitysystem and the manufacturer or importer has documentation ofsuch.

5、Description of testing conducted on the device, including anystandards met, such as

6、liquid barrier protection, flammability, biocompatibility, andfiltration performance, asappropriate. For surgical N95respirators, FDA recommends including fluid resistance testing(liquid barrier performance).