FDA issues new policy on coagulation systems for measurement of viscoelastic properties

Jan. 15, 2021

The U.S. Food and Drug Administration (FDA) issued a new policy to help expand the availability of coagulation systems for the measurement of whole blood viscoelastic properties that are used to assess hemostasis, according to a press release from the agency.

The policy, which is in effect immediately, will last for the duration of the COVID-19 public health emergency, the FDA said.

Specifically, the FDA said it does not intend to object to limited modifications to the indications, functionality, hardware, or software of the devices within the scope of the guidance without prior submission of a 510(k), where the modification does not create an undue risk to the patient in light of the public health emergency.

The immediately in effect guidance is called, Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Because hypercoagulability, or an abnormally increased risk for blood clotting, has been observed in patients with COVID-19, the goal of allowing modified use of coagulation systems is to make them more readily available for monitoring COVID-19 patients, the FDA said.

Coagulation systems for measurement of whole blood viscoelastic properties can help identify changes in coagulation status and are used routinely to aid in the assessment of hemostasis following certain surgical procedures and in the assessment of bleeding and thrombosis following a traumatic injury or event.

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