US FDA Releases a New Enforcement Policy for Coagulation Systems
Since the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities. A new enforcement policy has been released by the US FDA to facilitate the increased supply of coagulation systems used for assessing the viscoelastic properties of whole blood and the hemostasis in patients.