News & Analysis as of

Medical Equipment Emergency Use Authorization (EUA) Personal Protective Equipment

Faegre Drinker Biddle & Reath LLP

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

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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