News & Analysis as of

Medical Equipment Masks Coronavirus/COVID-19

Society of Corporate Compliance and Ethics...

Chinese manufacturer receives approval to deliver N95 masks to California

Report on Supply Chain Compliance 3, no. 13 (June 25, 2020): Chinese auto manufacturer BYD Auto Co. Ltd. received approval from the United States National Institute for Occupational Safety and Health (NIOSH) to sell U.S....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

Seyfarth Shaw LLP

Head to Toe: Summary of FDA COVID-19 Guidance Relating to Gowns, Other Apparel, and Gloves

Seyfarth Shaw LLP on

Along with the US Food and Drug Administration’s guidance addressing shortages of masks and respirators, FDA has released guidance aimed at increasing the supply of other personal protective equipment important in the fight...more

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