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超过70家中国口罩生产商获得美国FDA紧急使用(EUA)授权

* 来源: 福建省左海物流 左海物流 * 作者: admin * 发表时间: 2022-07-19 16:46:19 * 浏览: 69

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

5、如何申请EUA

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。

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).

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。

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 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。

冠状病毒病(COVID-19)紧急使用授权(EUA)信息官网:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations