The FDA has issued immediate guidance for expanding the availability and capability of coagulation systems for measuring whole blood viscoelastic properties to assess hemostasis. This guidance is intended to remain in effect for the duration of the COVID-19 public health emergency.
The recommendations apply to legally marketed, multipurpose systems for in vitro coagulation studies and coagulation systems for the measurement of whole blood viscoelastic properties.
Currently, no coagulation system is cleared or approved by the FDA for measuring whole blood viscoelastic properties in a hospital setting to help clinicians identify changes in coagulation status, including after surgical procedures or traumatic injuries. In addition, patients who are hospitalized with COVID-19–associated coagulopathy commonly display laboratory abnormalities such as mild thrombocytopenia, increased D-dimer levels, increased fibrin degradation products, and prolonged prothrombin time.
“[The] FDA believes the policy set forth in this guidance will help address these urgent public health concerns by helping to expand the availability and capability of coagulation systems for measurement of whole blood viscoelastic properties,” the authors of the guidance document stated.