FDA 口罩開通綠色通道（EUA）
FDA近日頒布了在新冠肺炎疫情期間口罩的緊急授權(quán)（可以理解成國(guó)內(nèi)綠色通道），并發(fā)布了相關(guān)指南，今天和大家簡(jiǎn)要說(shuō)說(shuō)這份指南的內(nèi)容。

綠色通道適用產(chǎn)品代碼

首先，F(xiàn)DA說(shuō)明了該政策適用的產(chǎn)品代碼范圍：

FDA 口罩開通綠色通道（EUA）
接著FDA說(shuō)明以下產(chǎn)品代碼不在該政策適用范圍，有且不限于以下這些：

FDA 口罩開通綠色通道（EUA）
醫(yī)療器械or非醫(yī)療器械

FDA在該指南中解釋了什么屬于醫(yī)療器械，什么不屬于醫(yī)療器械：

Face masks and respirators are devices when they are intended for a medical purpose, such as prevention of infectious disease transmission (including uses related to COVID-19).

Face masks andrespirators are not devices when they are intended for a non-medical purpose, such as for use in construction.

可以簡(jiǎn)單理解成有醫(yī)療用途的口罩就屬于醫(yī)療器械，沒(méi)有醫(yī)療用途的口罩就不屬于醫(yī)療器械。



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(lái)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(guò)的制造商，至于要怎么操作，發(fā)郵件問(wèn)FDA。