随着新冠疫情在美国不断蔓延,美国各类医疗物资陷入了紧缺的状态,尤其是个人防护口罩更是一罩难求。为了应对日益严峻的疫情,确保中国生产的KN95口罩快速进入美国市场。美国食品药品监督管理局FDA(U.S. Food&Drug Administration)早在今年2月初就开辟了快速认证通道-应急使用授权EUA(Emergency Use Authorization ),以取代NIOSH漫长冗杂的认证流程。EUA认证时间短、发证快、流程简单。
FDA 官网

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,并在官网上公布获得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。
3. 什么机构可以申请EUA?
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、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、中国以外的其他地区授权的,FDA可以进行验证;
三、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可能进行验证。
这其中最容易满足的应该是第三个条件。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
5EUA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
资料如下:
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 – Quality Management Systems – 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).
对于中国生产的KN95个人防护口罩,应该怎么申请EUA认证呢?
所需资料:
1,厂家的营业执照;
2,厂家的英文名字和地址需要跟商务部备案上面的一致;
3,产品的型号,标签(英文);
4,工厂体系文件(证书英文版QSR820orISO13485)
5,有CNAS盖章的GB2626报告或者EN 149报告;
6,疫情期间预计的出货数量
注意:
A. 产品型号不能包含中文;
B.标签要描述产品会销售的地方,比如医院等等;
C.EUA认证只是临时应急方案,暂时取代NIOSH认证,疫情结束后,需要重新回归到NIOSH认证。
D. EUA有效期限可能随时会被FDA终结。
EUA认证周期:资料合格,7-10个工作日。
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,就要发邮件问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 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 emergencyof 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。
(截止目前已经有74家中国KN95口罩生产厂家拿到EUA认证, 列表还在不断更新中。)
