在2020年 6月6日发布的EUA版本中提到的口罩,如果符合三个预先确定的资格标准中的任何一个,都将被授权 。该批准标准将不再适用于本公告 。
“Effective immediately, the reissued EUA no longer includes the three eligibility criteria, meaning the FDA will no longer review requests nor add to the list of authorized respirators–known as Appendix A—of this EUA based on those criteria.“
公告中提及“删除EUA资格标准”
“As part of our continuing work to meet the demands of this public health emergency, we undertook and completed a shortage assessment and concluded that reissuing this EUA was appropriate to reflect the current U.S. demand for these products,”
由于美国的疫情仍未好转,美国食品和药物管理局FDA认识到FFP仍然 供不应求。为了提供额外的需求,美国食品和药物管理局继续对重新发布 的EUA的附录A中包括的口罩型号授予紧急使用授权。
1,10月15号之后FDA将不再接受新的EUA申请;
2,10.15之前申请的但是还不在榜单上的有较大可能审核不过;
3,已在EUA榜单上的FDA会重新审核,再重新颁发EUA。