Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home Testing and CLIA Applicability.
CMS regulates clinical laboratory testing pursuant to the federal Clinical Laboratory Improvement Act (“CLIA”). Generally, a laboratory or clinical setting (such as a physician’s office) must obtain CLIA certification to perform laboratory testing. Some OTC tests, however, are approved by the Food and Drug Administration (“FDA”) for home use and the new FAQs address the use of OTC home tests in the workplace.
Following is an excerpt:
The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the ...
On March 22, 2011 the U.S. Supreme Court handed down a decision which is likely to have serious repercussions for companies in the bio/pharma tech space. In MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL., the Court rejected Matrixx argument that reports regarding the adverse effect of Zicam, its leading revenue generating product, were not statistically significant and therefore not material.
Noting that the analysis of materiality under the securities laws in fact specific, the Court appears to have relied heavily on two factors:
1. The methodologies and requirements ...
In a recent article “Food Safety and Whistleblowing – New Federal Law May Deliver a Full Basket of Claims,” EBG partners Allen Roberts and John Houston Pope discuss the FDA Food Safety Modernization Act (“FSMA”), which was signed into law on January 4, 2011.
This new federal law could have a significant impact on restaurateurs, clubs, and other hospitality employers who manufacture, distribute, transport, receive, hold or import food. FSMA opens wide a new door to whistleblower activity and protection, necessitating employer attention to related compliance ...
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