FDA近日颁布了在#肺炎疫情期间口罩的紧急授权（可以理解成国内绿色通道）。绿色通道适用产品代

首先，FDA说明了该政策适用的产品代码范围：

接着FDA说明以下产品代码不在该政策适用范围，有且不限于以下这些：

EUA（美国应急使用授权）**

1.发布时间及适用产品

注意事项

EUA申请流程1.递交申请（附相关资料）

2.FDA根据产品类型提交需要注册的资料清单

3.企业按要求递交相关资料

4.FDA对其进行审批

5.企业根据要求进行整改

6.FDA*终做出决定

其审批时间可能加快至半个月

EUA认可标准和证书产品面向医用市场

则产品满足以下标准或者认证即可：

欧盟CE 认证

澳大利亚ARTG

加拿大Health Canada Licence

日本PMDA/ MHLW

或以下相关标准：

或者直接获得美国NIOSH认证（限以下三种类型）

1) Non-powered air-purifying particulate FFRs and reusable respirators such as elastomeric half and full face piece respirators, approved by NIOSH in accordance

with 42 CFR Part 84 and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection;

2) Other powered air purifying respirators (PAPRs) approved by NIOSH, in accordance with 42 CFR Part 84, and that are listed on the NIOSH CEL for PAPRs

with particulate protection, and;

3) FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, are not damaged, and have been held in accordance with manufacturers’ storage conditions in strategic stockpiles,

for use in healthcare settings by HCPs .

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。

想了解更多检测认证相关资讯或者是有产品想要申请检测认证的欢迎拨打中拓热线：。

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