David Salkeld

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FDA Revises EUA for Respirators Manufactured in China

What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China....more

5/11/2020 / Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , NIOSH , Personal Protective Equipment

FDA Issues EUA for Face Masks

This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment...more

4/23/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Personal Protective Equipment , Public Health , Re-Opening Guidelines

FEMA: Certain Exports of Respirators, Masks, and Gloves (PPE) Exempt From Ban

The Federal Emergency Management Agency has left many important questions blowing in the wind as a result of a Notification of Exemptions action published for public inspection on Friday, April 17, 2020. The final action will...more

4/20/2020 / Coronavirus/COVID-19 , Customs and Border Protection , Export Controls , Exports , FEMA , Medical Supplies , Personal Protective Equipment

Update: Importation and Distribution of Face Masks and Respirators During the COVID-19 Pandemic

This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic. As reported in the news on a...more

4/6/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Personal Protective Equipment

The Importation of Personal Protective Equipment for Treatment of COVID-19

News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system. Masks, ventilators, and gowns are...more

3/25/2020 / Coronavirus/COVID-19 , Customs and Border Protection , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Personal Protective Equipment

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