HHS/FDA & Other Regulatory

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

On March 17, the FDA granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test…
Most Favored Nation Rule Poses Patient Access Issues, Faces Legal Challenges

As reported in last week’s BioUtah News and Events, HHS on Nov. 20 released an interim final rule…
FDA Posts Serology Templates for Test Developers

The FDA on Nov. 24 posted two templates with recommendations on what to include in EUA requests for…
HHS Move Upends FDA Role in Laboratory-Developed Test Regulation

By Adam Bonislawski for GenomeWeb NEW YORK – In a surprise move, the US Department of Health and…
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…
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…
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…
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…
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…
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…
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…
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…