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

The guidance is intended to foster continued availability of coagulation systems for measurement of viscoelastic properties during COVID-19

If your email program has trouble displaying this email, view as a webpage. FDA Issues New Policy on Coagulation Systems for Measurement of Viscoelastic Properties During the COVID-19 Public Health Emergency Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance: Enforcement Policy for Coagulation Systems for Measurement of Viscoelastic Properties During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Hypercoagulability has been observed in patients with COVID-19. 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. Modified use of these devices in hospital patient healthcare settings may increase access to important examination of whole blood viscoelastic properties to facilitate patient management by healthcare providers during the COVID-19 public health emergency. Read the Guidance This immediately in effect 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 measurement of whole blood viscoelastic properties to include use in hospital patient healthcare settings in response to the COVID-19 public health emergency. Describes the devices that are within the scope of the guidance. Explains that, for the duration of the public health emergency, the FDA 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.  Recommends that devices modified as described in the guidance 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. Questions? If you have questions about this guidance, email COVID19DX@fda.hhs.gov.

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