Gary Rom

Faegre Drinker Biddle & Reath LLP

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Latest Posts › Medical Devices

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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

In a May 7 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its April 3 LoA with revised eligibility EUA criteria for non-NIOSH-approved disposable filtering facepiece respirators...more

5/12/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices

FDA Eases Regulations On Face Masks And Respirators During COVID-19 Pandemic

On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the...more

4/1/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Medical Devices , Pharmaceutical Industry

FDA Issues Emergency Use Authorization for Ventilators, Tubing Connectors and Accessories

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more

3/31/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Suppliers , Supply Chain

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