FDA近日頒佈了在新冠肺炎疫情期間口罩的緊急授權（可以理解成國內綠色通道），併發布了相關指南，今天和大家簡要說說這份指南的內容。
綠色通道適用產品代碼
首先，FDA說明了該政策適用的產品代碼範圍：
接著FDA說明以下產品代碼不在該政策適用範圍，有且不限於以下這些：
醫療器械or非醫療器械
FDA在該指南中解釋了什麼屬於醫療器械，什麼不屬於醫療器械：
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.
可以簡單理解成有醫療用途的口罩就屬於醫療器械，沒有醫療用途的口罩就不屬於醫療器械。
如何申請EUA
未在美國境內的上市的醫療用途的外科口罩、N95口罩，不管是美國境內還是境外製造商，都可以申請緊急授權。需要遞交以下資料，併發送到FDA 這個郵箱：[email protected]，由FDA審核是否可以授予緊急授權，讓該產品在新冠疫情期間在美國境內銷售。
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).
以上遞交資料適用於本來就已經生產醫療器械、但口罩尚未在美國境內上市的製造商。有兩點是需要注意的：
1、FDA只是減免了510（k）技術文檔要求，但關於產品測試，生產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期間內，FDA不拘泥於任何區域的產品標準，只要你是做相關產品測試，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，FDA也歡迎非醫療器械企業生產銷售醫療器械，可以粗暴理解成就是連生產車間QSR820都未外審過的製造商，至於要怎麼操作，發郵件問FDA。
額外要求
FDA對於緊急授權下的口罩產品，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; and
- 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; and
- 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緊急授權的產品。
參考信息：
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-face-masks-and-respirators-during-coronavirus-disease-covid-19-public-health
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