Topic Archives: Medical Devices + Diagnostics

May 26, 2020 - COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Product Liability + Class Action, United States

FDA Signals Flexibility with COVID-19 Tests

By: Bethany J. Hills, Erin M. Bosman, Julie Y. Park, and Daniela Peinado Welsh

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps to …›

May 8, 2020 - COVID-19, FDA, Medical Devices + Diagnostics, Product Liability + Class Action, United States

COVID-19 Alert: FDA updates antibody test policy

By: Bethany J. Hills, Erin M. Bosman, Julie Y. Park, and Daniela Peinado Welsh

Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been …›

April 22, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, Product Liability + Class Action, United States

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Bethany J. Hills, Julie Y. Park, Anastasiya V. Menshikova, Anthony Michael Parenti, and Hilary R. Hoffman

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel …›

April 9, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, Product Liability + Class Action, United States

CARES Act of 2020: Guide for Drug and Device Companies

By: Stephanie L. Blij and Bethany J. Hills

The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. …›

March 31, 2020 - COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Product Liability + Class Action, United States

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman, Julie Y. Park, Bethany J. Hills, Hilary R. Hoffman, and Alexander A. Najarian

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Read our Class Dismissed …›

March 23, 2020 - COVID-19, FDA, Medical Devices + Diagnostics, Product Liability + Class Action

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

By: Erin M. Bosman, Julie Y. Park, and Alexander A. Najarian

COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical …›

March 17, 2020 - Biotech, COVID-19, FDA, Healthcare, Medical Devices + Diagnostics, Pharma, United States

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

By: Keunbong (KB) Do and Bethany J. Hills

On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health …›

March 11, 2020 - Biotech, COVID-19, Healthcare, Medical Devices + Diagnostics, Pharma, United States

U.S. government announces new federal funding opportunities related to COVID-19

By: Tina D. Reynolds and Bethany J. Hills

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding to companies …›