多家中國企業在列,美國發布最新呼吸機及配件EUA清單

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FDA又再發布呼吸機EUA
 
授權多家中國企業
 

本文摘譯自FDA 2020年6月25日

以下為詳文

 

持續呼吸機是一種通過在呼吸氣體中輸送預定百分比的氧氣來機械控制或協助患者呼吸的裝置。FDA曾經發布EUA,助力增進呼吸機和呼吸機附件的可用性,這是COVID-19大流行期間治療嚴重呼吸窘迫患者所不可或缺的。

 

FDA網站截圖

 

關于呼吸機和呼吸機配件的《傘式EUA》

2020年3月24日,FDA發文《傘式EUA》,以應對COVID-19大流行期間FDA批準的用于醫療機構治療患者時的呼吸機在供應性和可用性方面的不足。該《EUA》緊急授權某些呼吸機、氣體麻醉機改裝的呼吸機、正壓呼吸裝置改裝的呼吸機、呼吸機管連接器和呼吸機附件,并確定了這些設備在符合安全、性能和標簽方面的特定標準。按照《EUA》,符合入選資格的設備是那些目前沒有在美國銷售的產品,或是那些目前在美國銷售但又對設備進行了改裝的產品,正如FDA《呼吸機強制實施政策》中所討論的,要求制造商向FDA提交新的上市前通知(510(k))。

 

呼吸機參考版權圖

 

本授權的范圍僅限于呼吸機、呼吸機管連接器和呼吸機附件的使用,列表見附錄B:COVID-19流行期間供患者在醫療環境中使用的已授權的呼吸機、呼吸機管連接器和呼吸機附件。

 

■EUA授權書---呼吸機、氣體麻醉機改裝的呼吸機、正壓呼吸裝置改裝的呼吸機(統稱為“呼吸機”)、呼吸機管連接器和呼吸機附件

醫療保健提供者的資料表

患者的資料表

附錄A:安全、性能和標簽的標準

附錄B:已授權的呼吸機、呼吸機管連接器和呼吸機附件

 

呼吸機EUA:根據呼吸機EUA的規定,用于向FDA提供信息的交互審查模板支持納入合格產品:《呼吸機EUA交互審查模板》(2020年4月21日更新版)。

 

下表列出了在《傘式EUA》中授權的呼吸機、呼吸機管連接器和呼吸機附件。

 

附錄B:授權的呼吸機、呼吸機管接頭和呼吸機配件(更新日期:2020年6月29日)

 

下表是COVID-19突發公共衛生事件期間根據《傘式EUA》中的授權產品清單所列出的包含授權呼吸機、呼吸機管接頭和呼吸機附件在內的一份清單。

授權呼吸機

授權呼吸機管連接器

授權呼吸機附件

 


 

 

原文:

 

 

Ventilators and Ventilator Accessories EUAs

June 25, 2020 By FDA

 

A continuous ventilator is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. FDA has issued EUAs to help increase the availability of ventilators and ventilator accessories, which are integral to treat patients with severe respiratory distress during the COVID-19 pandemic.

 

Umbrella EUA for Ventilators and Ventilator Accessories

On March 24, 2020, FDA issued an umbrella EUA in response to concerns about the insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. This EUA authorizes the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance, and labeling. The devices that are eligible for inclusion under the EUA are those that are not currently marketed in the U.S., or those that are currently marketed in the U.S. but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the FDA, as discussed in the agency's Ventilator Enforcement Policy.

 

The scope of this authorization is limited to the use of ventilators, ventilator tubing connectors, and ventilator accessories listed below in Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories for use in healthcare settings by patients during the COVID-19 pandemic.

 

EUA Letter of Authorization - Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories

?Facts Sheets for Healthcare Providers

?Facts Sheets for Patients

?Appendix A: Criteria for Safety, Performance and Labeling

?Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories

For Ventilator EUA: The interactive review template, which can be used to provide information to FDA, to support inclusion of an eligible product under the Ventilator EUA is available: Ventilator EUA Interactive Review Template (Updated April 21, 2020)

 

The tables below lists the ventilators, ventilator tubing connectors, and ventilator accessories authorized in this umbrella EUA.

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated June 25, 2020)

The table below includes a list of authorized ventilator, ventilator tubing connector, and ventilator accessory to the list of authorized products in this Umbrella EUA during the COVID-19 public health emergency.

 

?Authorized Ventilators

?Authorized Ventilator Tubing Connectors

?Authorized Ventilator Accessories

 

 

 

 

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