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

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

什么機構可以申請EUA？

在FDA的指導里面寫明,可以申請EUA的目前有兩種機構:一是實驗室,可以申請EUA獲得檢測允許;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EUA，給器械獲取緊急時期的使用資格。

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

一是擁有一個或多個NIOSH(美國國家職業(yè)安全衛(wèi)生研究所)認證產(chǎn)品的制造商，按照其他國家/地區(qū)的適用授權標準生產(chǎn)的其他型號的過濾式面罩呼吸器(FFR)，F(xiàn)DA可以進行驗證；

二是中國以外的其他地區(qū)授權的，F(xiàn)DA可以進行驗證；

三是有獨立的測試實驗室出具的檢測報告，能顯示其產(chǎn)品性能符合適用的測試標的，F(xiàn)DA可以進行驗證。

這其中最容易滿足的應該是第3個條件。注意：

（EUA）有效期：這個授權僅在爆發(fā)期間有效，F(xiàn)DA認為結束的時候該EUA就會失效。疫情結束后需要重新做NIOSH認證

如何申請EUA

未在美國境內(nèi)的上市的醫(yī)療用途的外科口罩、N95口罩，不管是美國境內(nèi)還是境外制造商，都可以申請緊急授權。需要遞交以下資料，并發(fā)送到FDA 這個郵箱：CDRH-COVID19-SurgicalMasks@fda.hhs.gov，由FDA審核是否可以授予緊急授權，讓該產(chǎn)品在新冠疫情期間在美國境內(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、但口罩尚未在美國境內(nèi)上市的制造商。有兩點是需要注意的：

1、FDA只是減免了510（k）技術文檔要求，但關于產(chǎn)品測試，生產(chǎn)車間質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)品標準，只要你是做相關產(chǎn)品測試，歐盟的、中國的，都可以將測試報告遞交，由FDA決定是否可以授予緊急授權。

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對于緊急授權下的口罩產(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授權的口罩，要在包裝標識上明確這是FDA緊急授權的產(chǎn)品。

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

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