Health Law Scan

Members of our labor and employment and healthcare teams recently published a LawFlash covering the US Department of Justice’s (DOJ’s) definitive guidance which specifically concluded that “federal law does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to emergency use authorizations from the U.S. Food and Drug Administration.”

Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health. The most immediate and significant changes impacting FDA’s medical device oversight are likely to include a repeal of certain Trump administration orders on regulatory reform and changes in leadership at both FDA and the US Department of Health and Human Services (HHS). Certain FDA priorities, however, including efforts to prioritize COVID-19-related medical devices and digital health technologies, are expected to continue under the new administration. Device companies should be prepared for an uptick in FDA enforcement activity, including those that received Emergency Use Authorizations (EUAs) for products intended to aid in COVID-19 relief efforts.

Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. These newly authorized testing options are expected to help address the critical public health need for additional COVID-19 test capacity. FDA’s authorization of these new EUAs also makes good on promises the FDA made to prioritize its review of rapid and at-home test solutions.