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FDA Issues Umbrella EUA for Surgical Masks

The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators Manufactured in China

On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...more

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China

On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute...more

FDA Issues Guidance on Use of 3D Printing on Medical Devices, Accessories, Components, and Parts

On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more

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