又雙翻轉(zhuǎn)！74家中國(guó)口罩生產(chǎn)企業(yè)獲美緊急使用授權(quán)（附如何申請(qǐng)EUA）

美國(guó)食品藥品監(jiān)督管理局（FDA）網(wǎng)站顯示，截至4月14日，已有74家工廠位于中國(guó)的企業(yè)所生產(chǎn)的口罩獲緊急使用授權(quán)（EUA）。其中既包括3M中國(guó)這樣的外商獨(dú)資企業(yè)，更多的則是比亞迪、奧美醫(yī)療、永泰三聯(lián)、金納爾醫(yī)療等中國(guó)本土生產(chǎn)商。

什么機(jī)構(gòu)可以申請(qǐng)EUA？

在FDA的指導(dǎo)里面寫明,可以申請(qǐng)EUA的目前有兩種機(jī)構(gòu):一是實(shí)驗(yàn)室,可以申請(qǐng)EUA獲得檢測(cè)允許;第二種就是醫(yī)療器械公司，有研發(fā)制造能力的可以申請(qǐng)EUA，給器械獲取緊急時(shí)期的使用資格。

根據(jù)FDA文件，中國(guó)生產(chǎn)的口罩獲得EUA授權(quán)，需要滿足三個(gè)要求：

一是擁有一個(gè)或多個(gè)NIOSH(美國(guó)國(guó)家職業(yè)安全衛(wèi)生研究所)認(rèn)證產(chǎn)品的制造商，按照其他國(guó)家/地區(qū)的適用授權(quán)標(biāo)準(zhǔn)生產(chǎn)的其他型號(hào)的過濾式面罩呼吸器(FFR)，F(xiàn)DA可以進(jìn)行驗(yàn)證；

二是中國(guó)以外的其他地區(qū)授權(quán)的，F(xiàn)DA可以進(jìn)行驗(yàn)證；

三是有獨(dú)立的測(cè)試實(shí)驗(yàn)室出具的檢測(cè)報(bào)告，能顯示其產(chǎn)品性能符合適用的測(cè)試標(biāo)的，F(xiàn)DA可以進(jìn)行驗(yàn)證。

這其中最容易滿足的應(yīng)該是第3個(gè)條件。注意：

（EUA）有效期：這個(gè)授權(quán)僅在爆發(fā)期間有效，F(xiàn)DA認(rèn)為結(jié)束的時(shí)候該EUA就會(huì)失效。疫情結(jié)束后需要重新做NIOSH認(rèn)證

如何申請(qǐng)EUA

未在美國(guó)境內(nèi)的上市的醫(yī)療用途的外科口罩、N95口罩，不管是美國(guó)境內(nèi)還是境外制造商，都可以申請(qǐng)緊急授權(quán)。需要遞交以下資料，并發(fā)送到FDA 這個(gè)郵箱：CDRH-COVID19-SurgicalMasks@fda.hhs.gov，由FDA審核是否可以授予緊急授權(quán)，讓該產(chǎn)品在新冠疫情期間在美國(guó)境內(nèi)銷售。

資料如下：

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).

以上遞交資料適用于本來就已經(jīng)生產(chǎn)醫(yī)療器械、但口罩尚未在美國(guó)境內(nèi)上市的制造商。有兩點(diǎn)是需要注意的：

1、FDA只是減免了510（k）技術(shù)文檔要求，但關(guān)于產(chǎn)品測(cè)試，生產(chǎn)車間質(zhì)量體系的要求是從未有放棄的；

2、在新冠肺炎疫情爆發(fā)期間內(nèi)，F(xiàn)DA不拘泥于任何區(qū)域的產(chǎn)品標(biāo)準(zhǔn)，只要你是做相關(guān)產(chǎn)品測(cè)試，歐盟的、中國(guó)的，都可以將測(cè)試報(bào)告遞交，由FDA決定是否可以授予緊急授權(quán)。

此外，F(xiàn)DA也歡迎非醫(yī)療器械企業(yè)生產(chǎn)銷售醫(yī)療器械，可以粗暴理解成就是連生產(chǎn)車間QSR820都未外審過的制造商，至于要怎么操作，發(fā)郵件問FDA。

額外要求

FDA對(duì)于緊急授權(quán)下的口罩產(chǎn)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.

獲得EUA授權(quán)的口罩，要在包裝標(biāo)識(shí)上明確這是FDA緊急授權(quán)的產(chǎn)品。

冠狀病毒?。–OVID-19）緊急使用授權(quán)（EUA）信息官網(wǎng)（或點(diǎn)擊閱讀原文）：

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