Devices

Covid-19 Coagulation Systems Guidance

FDA has issued 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 provide a policy to help expand the availability of coagulation systems for measuring whole blood viscoelastic properties that are used to assess hemostasis. The document is intended to remain in effect only for the duration of the Covid-19 public health emergency.

An agency news release says hypercoagulability has been observed in Covid-19 patients. It says the guidance:

is intended to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to coagulation systems for measuring whole blood viscoelastic properties to include use in hospital patient healthcare settings in response to the pandemic;
describes the devices that are within the scope of the guidance;
explains that during the public health emergency FDA will not object to limited modifications to the indications, functionality, hardware, or software of the devices within the guidance scope 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; and
recommends that devices modified as described in the document include certain labeling elements to help ensure that such devices do not create undue risk to the patient and to help users understand the device modifications under the policy.

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