Theodore Lis

Faegre Drinker Biddle & Reath LLP

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FDA Amends Imported Non-NIOSH Approved Respirator EUA

In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more

6/24/2020 / Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Imports , Medical Devices , Medical Equipment , NIOSH

FDA Revises Enforcement Policy for Face Masks and Respirators

On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...more

6/24/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , NIOSH , Personal Protective Equipment

FDA Revises EUA Criteria for Respirators Manufactured in China (Updated)

In a June 6 Letter of Authorization (LoA) regarding the emergency use authorization (EUA) for non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators manufactured...more

6/24/2020 / Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Equipment , NIOSH , Personal Protective Equipment

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