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Medical Equipment Medical Devices Emergency Use Authorization (EUA)

Faegre Drinker Biddle & Reath LLP

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

Mintz - Health Care Viewpoints

FDA Reverses Decision to Authorize Use of Chinese KN95 Respirators

Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the...more

Mintz - Health Care Viewpoints

FDA Expands Face Mask Enforcement Policy to Allow Imports of KN95 Respirators

On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more

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