Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

On 28 January 2021 the FDA published the final guidance for industry and FDA staff.

FDA is issuing this guidance to provide a policy to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis, for the duration of the COVID-19 public health emergency. This document updates the guidance of the same title issued on January 14, 2021.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).