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HHS/FDA COVID-19 NEWS

May 8, 2020
FDA Requires Review of COVID-19 Antibody Tests

To ensure the accuracy of COVID-19 antibody tests and guard against fraudulent testing claims, the FDA recently announced that it would update its March 16, 2020 guidance and start requiring serology test developers to obtain an Emergency Use Authorization (EUA). The agency has also outlined test performance expectations. Manufacturers that have already commercialized product based […]

April 3, 2020
IRS: Employee Retention Credit available for many businesses financially impacted by COVID-19

WASHINGTON — The Treasury Department and the Internal Revenue Service today launched the Employee Retention Credit, designed to encourage businesses to keep employees on their payroll. The refundable tax credit is 50% of up to $10,000 in wages paid by an eligible employer whose business has been financially impacted by COVID-19. Click below for answers to […]

April 2, 2020
WASATCH COUNTY HEALTH OFFICER PUBLIC HEALTH ORDER TO PROTECT THE PUBLIC FROM COVID-19

Wasatch County has issued a Stay At Home Order effective through April 14, 2020.  Here are the key elements. Health Care and Public Health Operations are designated as Essential Businesses and include the following in the definition:  “pharmaceutical, pharmacy, medical device and equipment, and biotechnology companies (including operations, research and development, manufacture, and supply chain” […]

March 30, 2020
CISA: Advisory Memorandum on Identification of Essential Critical Infrastructure Workers During COVID-19 Response

“As the Nation comes together to slow the spread of COVID-19, on March 16th the President issued updated Coronavirus Guidance for America that highlighted the importance of the critical infrastructure workforce. The Cybersecurity and Infrastructure Security Agency (CISA) executes the Secretary of Homeland Security’s authorities to secure critical infrastructure. Consistent with these authorities, CISA has […]

March 26, 2020
CMS Adult Elective Surgery and Procedures Recommendations:

Limit all non-essential planned surgeries and procedures, including dental, until further notice “To aggressively address COVID-19, CMS recognizes that conservation of critical resources such as ventilators and Personal Protective Equipment (PPE) is essential, as well as limiting exposure of patients and staff to the SARS-CoV-2 virus. See below guidance to limit non-essential adult elective surgery […]

March 26, 2020
FDA: Letter to the Industry on COVID-19

The FDA has written a letter addressed to medical device establishments in order to address the impact of the COVID-19 pandemic on day-to-day operations in the FDA’s Center for Devices and Radiological Health (CDRH) and in the medical device industry.   Read the Letter

March 24, 2020
Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

“March 24, 2020 – Today, the U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturersExternal Link Disclaimer importing personal protective equipment and other devices. One of FDA’s priorities in combating the COVID-19 pandemic is facilitating access to critical personal protective equipment (PPE) and […]

March 22, 2020
Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

“‘Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. ‘The FDA’s new actions will mean America can make more ventilators during this crisis,’ said Health and Human Services […]

March 16, 2020
The Department of Health and Human Services on PREP

The Department of Health and Human Services issued a declaration on March 16 under the Public Readiness and Emergency Preparedness (“PREP”) Act to provide immunity to liability for activities related to medical countermeasures against COVID-19. The declaration is effective retroactively to February 4, 2020. The notice will be published in the Federal Register March 17. […]