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# FDA Updates Pandemic Coagulation System Guidance
- URL: https://www.fdaweb.com/fda-updates-pandemic-coagulation-system-guidance/
- Published: 2021-01-28T12:00:00.000Z
- Updated: 2026-09-14T16:44:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148549

FDA has updated an immediately-in-effect guidance, *Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency*, 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. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/coagulation-systems-measurement-viscoelastic-properties-enforcement-policy-during-coronavirus?ref=fdaweb.com) includes an Introduction, Background, Scope, and Policy relating to **(1)** modifications to indication, hardware, and software; and **(2)** labeling of modified devices.