HHS/FDA & Other Regulatory

FDA Permits Marketing of BioFire COVID-19 Diagnostic Test Using Traditional Premarket Review Process

Posted on April 14, 2021 by Denise Bell

On March 17, the FDA granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency […]

Most Favored Nation Rule Poses Patient Access Issues, Faces Legal Challenges

Posted on November 25, 2020 by Denise Bell

As reported in last week’s BioUtah News and Events, HHS on Nov. 20 released an interim final rule (IFR) implementing the Most Favored Nation (MFN) Model, a new payment model through the Center for Medicare and Medicaid Innovation (CMMI) that would, starting January 1, base the price Medicare pays for for 50 high-cost Medicare Part […]

FDA Posts Serology Templates for Test Developers

Posted on November 25, 2020 by Denise Bell

The FDA on Nov. 24 posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen […]

HHS Move Upends FDA Role in Laboratory-Developed Test Regulation

Posted on August 28, 2020 by admin

By Adam Bonislawski for GenomeWeb NEW YORK – In a surprise move, the US Department of Health and Human Services said on Wednesday that it had determined the Food and Drug Administration would not require premarket review of laboratory-developed tests without notice-and-comment rulemaking. The announcement, which took many in the lab industry aback, appeared to […]

FDA Requires Review of COVID-19 Antibody Tests

Posted on May 8, 2020 by Denise Bell

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 […]

IRS: Employee Retention Credit available for many businesses financially impacted by COVID-19

Posted on April 3, 2020 by admin

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 […]

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

Posted on March 30, 2020 by admin

“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 […]

CMS Adult Elective Surgery and Procedures Recommendations:

Posted on March 27, 2020 by Denise Bell

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 […]

FDA: Letter to the Industry on COVID-19

Posted on March 27, 2020 by Denise Bell

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 […]

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

Posted on March 26, 2020 by Denise Bell

“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 […]

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

Posted on March 27, 2020 by Denise Bell

“‘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 […]

The Department of Health and Human Services on PREP

Posted on March 26, 2020 by Denise Bell

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. […]