News & Analysis as of

Personal Protective Equipment Food and Drug Administration (FDA) NIOSH

Davis Wright Tremaine LLP

Stay ADvised: 2024, Issue 11

Plaintiff Says Splenda 100% Natural Ad Claims Leave a Bitter Taste - A class action lawsuit accuses the makers of Splenda Naturals Stevia, a sugar alternative, of misleading consumers with the claim that the product is...more

Maynard Nexsen

The FDA Revokes EUAs for Decontamination Systems and Non-NIOSH-Approved Respirators (i.e., KN95 Respirators)

Maynard Nexsen on

Since early last year, the United States Food and Drug Administration (FDA) issued several Emergency Use Authorizations (EUAs) for personal protective equipment (PPE) products to address concerns about their availability...more

Faegre Drinker Biddle & Reath LLP

FDA Revises Enforcement Policy for Face Masks and Respirators

On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...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

Seyfarth Shaw LLP

FDA Revises Guidance on Face Masks, Respirators, and Face Shields to Address Covid-19 Concerns

Seyfarth Shaw LLP on

Earlier last week, the US Food and Drug Administration (FDA) issued new and revised guidance on its enforcement policy for face masks, surgical masks, respirators, and face shields during the COVID-19 emergency in response to...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

ArentFox Schiff

FDA Revises EUA for Respirators Manufactured in China

ArentFox Schiff on

What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China. ...more

Seyfarth Shaw LLP

FDA Updates Emergency Use Authorization For Chinese Respirators

Seyfarth Shaw LLP on

Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...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

Woods Rogers

Buyer Beware: The Sale of Fake Face Masks is Proliferating

Woods Rogers on

The global scope of the coronavirus pandemic has resulted in a severe shortage of respirators, or what people commonly call face masks.  In the U.S., the National Institute for Occupational Safety and Health (NIOSH) manages...more

Arnall Golden Gregory LLP

Understanding USP 800: A Resource for Long-Term Care Providers

Introduction - When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous...more

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