Title
FDA重新發布了中國制造過濾式面罩呼吸器（FFR）的緊急使用授權（EUA）
發布時間：2020/5/8 14:21:00 文章來源：百度新聞 點擊量：3005
FDA重新發布了中國制造過濾式面罩呼吸器（FFR）的緊急使用授權（EUA）
FDA Reissues Emergency Use Authorization (EUA) for Filtering Facepiece Respirators (FFR) manufactured in China
2020年5月7日，美國食品藥品監督管理局（FDA）為在中國生產的不符合NIOSH標準的一次性過濾式口罩呼吸器發布了經修訂的《緊急使用授權》。 經修訂的EUA包括更新的附錄，該附錄列出了由醫療保健提供者（HCP）授權在醫療保健場所使用的呼吸器，以防止暴露于SARS-CoV-2。 附錄已更新，以刪除某些不再根據EUA授權的呼吸器。
On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization for disposable filtering facepiece respirators manufactured in China that do not meet NIOSH standards. The revised EUA includes an updated appendix that lists the respirators that have been authorized for use in health care settings by health care providers (HCPs) to prevent exposure to SARS-CoV-2. The appendix was updated to remove certain respirators that are no longer authorized under the EUA.
根據2020年5月7日重新發布的EUA，為了將您的FFR作為授權呼吸器添加到附錄A中，必須滿足以下資格標準之一：
Under the reissued May 7, 2020 EUA, in order for your FFR to be added to Appendix A as an authorized respirator, one of the following eligibility criteria must be met:
1.生產企業依照他國授權適用標準制造的其他型號FFRs有一個或者多個NIOSH批準， 可由FDA驗證；要么
1. It is manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA; or
2.企業產品通過了其他國家的認證，包括由適當的省或市監管機構頒發的中國國家藥品監督管理局（NMPA）注冊證明，可以由FDA進行認證和驗證;要么
2. It has a regulatory authorization under a jurisdiction, including the Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority, that can be authenticated and verified by FDA; or
3.之前已在2020年4月3日的授權書附錄A中列為授權呼吸器，因為它已被證實符合測試報告所記錄的適用標準的可接受性能，并本EUA發布之日起45個日歷天內，已由NIOSH使用改良版的NIOSH標準測試程序（STP）TEB-APR-STP-0059評估了顆粒過濾效率，并已具備NIOSH測試結果，表明最小和最大過濾效率大于或等于95％。
3. It was previously listed in Appendix A under the April 3, 2020 letter of authorization as an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.
FDA將根據標準三從已經進口的大量呼吸器中抽取呼吸器樣品。如果重新發布EUA時制造商尚未將呼吸器運到美國，則FDA將與符合此標準的制造商合作，以便在到達美國入境口岸時對呼吸器進行采樣。
FDA will sample respirators from already imported lots of respirators under criterion three. If a manufacturer has not shipped respirators to the United States at the time this EUA is reissued, FDA will work with a manufacturer who is eligible for this criterion in order to sample respirators once they arrive at a US port of entry.
