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Biden Administration's End to COVID-19 Public Health Emergency to Impact Devices Under Enforcement Discretion

On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

FDA Holds Webinar on Draft Transition Plans for COVID-19 Related Medical Devices and Enhances 510(k) Submission Tracker

On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more

FDA Issues Draft Transition Plans for Medical Devices Commercialized Pursuant to EUA or Enforcement Discretion Policy During...

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the...more

CMS to Require COVID-19 Vaccines by January 4, 2022 for Many Healthcare Staff

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an Interim Final Rule (IFR) with Comment Period, 86 Fed. Reg. 61555 (Nov. 5, 2021), requiring mandatory COVID-19 vaccination of staff of many...more

Administrative Notice Limits the FDA's Ability to Regulate Laboratory Developed Tests, Including COVID-19 Tests

Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more

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

In a Move Designed to Benefit Patients, the President Signs an Executive Order to Pass Drug Manufacturer Rebates Directly to...

Recently, the President issued an executive order (EO) for the purpose of ensuring that discounts offered on prescription drugs be passed down to patients. The subject matter of EO represents a key plank of a platform to 1)...more

Primer on EUAs for COVID-19 Tests

This Client Advisory addresses some frequently asked questions for SARS-CoV-2 diagnostic test developers and provides an overview of recent updates relating to Emergency Use Authorizations (EUAs) published by the U.S. Food...more

President Signs a "Buy American for Essential Drugs and Medical Supplies" Executive Order

Against a backdrop of an ongoing, disruptive COVID-19 pandemic; natural security concerns about disruptions in the availability of drugs, personal protective equipment, and diagnostic tests—and the widely variable quality of...more

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators Manufactured in China

On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...more

FDA Issues Revised EUA for Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China

On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute...more

CMS Further Loosen Restrictions and Lighten Burdens on Providers During the COVID-19 Emergency

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued new regulatory waivers and rule changes aimed at expanding access to care and allaying regulatory burdens on healthcare providers during the...more

CMS Issues Phase 1 Recommendations for Re-Opening Certain Healthcare Facilities

On April 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Phase 1 of recommendations for re-opening certain healthcare facilities that provide non-emergent healthcare following COVID-19 related...more

FDA and FTC Send Joint Warning Letters to Multiple Companies for "Selling Fraudulent COVID-19 Products"

The number of cases of SARS-CoV-2 corona virus infection, and COVID-19, the disease caused by virus, continues to increase in the United States—both in number and in location (real-time map). At the same time, the number and...more

The CARES Act: A Summary for Technology and Life Sciences Companies

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), a $2 trillion stimulus package thought to be the largest in U.S. history. This is the third stimulus package adopted...more

The Cares Act Brings Changes for Drug and Medical Device Oversight and New Options for Telehealth Services

On March 27, 2020, President Trump signed Public Law 116-136, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), the federal government's latest and most ambitious response to the COVID-19 crisis. As yet,...more

FDA Issues Guidance on Use of 3D Printing on Medical Devices, Accessories, Components, and Parts

On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more

FDA Issues Guidance on Clinical Trials During the COVID-19 Pandemic

On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance on clinical trials of medical products during the COVID-19 pandemic, which provides general considerations to help sponsors assure the...more

FDA Issues "Immediately in Effect" Guidance to Accelerate Availability of COVID-19 Diagnostic Tests

The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more

FDA and FTC Send Joint Warning Letters to Seven Companies for "Selling Fraudulent COVID-19 Products"

The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more

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