News & Analysis as of

NIOSH Medical Equipment

Jackson Lewis P.C.

Surgical Masks, Respirators, And More: Employers Grapple With Personal Protective Equipment Requirements Amid Constantly Evolving...

Jackson Lewis P.C. on

Eight months into the coronavirus (“COVID-19”) pandemic and employers in both healthcare and non-healthcare settings are grappling with requirements for employees’ use of personal protective equipment (“PPE”) and respiratory...more

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

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

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

Harris Beach PLLC

NIOSH-Approved Masks Defined as Covered Countermeasures for Liability Immunity Under Amended PREP Act Declaration

Harris Beach PLLC on

As concern about availability of personal protective equipment (“PPE”) continues to grow amid the COVID-19 pandemic, the federal government continues to take action aimed at increasing the availability of PPE with important...more

White and Williams LLP

OSHA Releases COVID-19 Guidance

White and Williams LLP on

The United States Department of Labor’s Occupational Safety and Health Administration (OSHA) ensures safe and healthful working conditions for employees by setting and enforcing standards and by providing training, outreach,...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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