News & Analysis as of

Personal Protective Equipment Coronavirus/COVID-19 Food and Drug Administration (FDA)

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

Wiley Rein LLP

The End of an Era: FDA Announces Disposition Plans for COVID-19 Related Guidance Documents

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The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of critical drugs, medical devices, and biologic...more

Amundsen Davis LLC

EEOC Issues New Guidance on COVID-19 Testing

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On July 12, 2022, the Equal Employment Opportunity Commission (EEOC) - the federal agency responsible for enforcing anti-discrimination laws - issued new guidance on when employers may require employees to screen/test...more

Mintz - Employment Viewpoints

EEOC Updates Screening, Testing, and Mandatory Vaccination Polices

After several months, the EEOC has once again updated its guidance and answers regarding the ongoing COVID-19 pandemic’s interaction with anti-discrimination laws, with a particular focus on the workplace screening, testing,...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies...

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #1

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Last week, the Centers for Disease Control and Prevention (CDC) revised its mask guidance for fully vaccinated individuals. Also, while the Administration and several health care institutions evaluate the possibility of...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

Arnall Golden Gregory LLP

Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration...

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #3

Alston & Bird on

In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Jackson Lewis P.C.

OSHA Issues COVID-19 Respiratory Protection Guidance For Long Term Care Facilities

Jackson Lewis P.C. on

OSHA has issued guidance on personal protective equipment (“PPE”) and respiratory protection use in nursing home and long term care facilities (collectively “LTCFs”) to protect against COVID-19. In its recently issued...more

Foley & Lardner LLP

CPSC Issues COVID-19 Consumer Products Guidance, Further Muddying the Regulatory Waters and Increasing Scrutiny of COVID-19...

Foley & Lardner LLP on

As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant...more

Pillsbury Winthrop Shaw Pittman LLP

What Will the Biden/Harris COVID-19 Plan Mean for Business?

The incoming Biden Administration promises a more nationalized approach to combatting the COVID-19 public health crisis, plus a large economic stimulus response focused on unemployment, paid leave, state and local government...more

McGuireWoods LLP

CPSC Issues “Unofficial” COVID-19 Guidance on Personal Protective Equipment, Disinfectants

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The Consumer Product Safety Commission (CPSC) has posted a webpage that purports to provide guidance on COVID-19-related consumer products. The CPSC’s new COVID-19 guidance covers two general categories...more

Harris Beach PLLC

FDA Limits Respirator Manufacturers who can Apply for Authorization Under EUA

Harris Beach PLLC on

The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more

Wilson Sonsini Goodrich & Rosati

FDA Declines to Review Certain EUAs, Raising Reimbursement and Liability Issues

The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, October 2020 # 10

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In Washington: State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they lack enough money to carry out the immense...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – October 2020

Hogan Lovells on

In Washington: Speaker Nancy Pelosi (D-CA) said Thursday that White House negotiators seeking a coronavirus relief deal have simply not offered enough money to bring Democrats on board. Treasury Secretary Steven Mnuchin on...more

Moritt Hock & Hamroff LLP

Protecting Your Business When Entering Into A PPE Agreement

Although many businesses throughout the United States were decimated during the Covid-19 pandemic, a few have been able to pivot and take advantage of new opportunities unfolding in the now lucrative market for personal...more

Jackson Lewis P.C.

More Guidance On COVID-19 Response Measures For FDA Regulated Human And Animal Food Operations

Jackson Lewis P.C. on

To help employers in regulated human and animal food operations navigate ongoing challenges from the coronavirus (“COVID-19”) pandemic, the U.S. Food and Drug Administration (“FDA”), Centers for Disease Control and Prevention...more

Faegre Drinker Biddle & Reath LLP

COVID-19 Weekly Newsletter: Back-to-School Snags, Research Breakthroughs

Rising unemployment rates, continued deliberations on another federal relief package, and schools implementing remote learning after on-campus spikes in case rates marked an eventful week in the COVID-19 pandemic response....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Umbrella EUA for Surgical Masks

The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” in the Twilight Zone: Executive Order Strengthening the U.S. Public Health Industrial Base

On August 6, 2020, President Trump signed the “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States,” requiring, among other things, the U.S. government...more

Hogan Lovells

FDA takes action to reduce surgical mask shortage

Hogan Lovells on

To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable,...more

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