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

The update clarifies what the labeling of modified devices should include.

If your email program has trouble displaying this email, view as a webpage. FDA Updates 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) updated the 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 policy remains unchanged from the initial publication of this guidance; however, this update provides a minor clarification for one of the labeling recommendations. Specifically, the revised guidance recommends that the labeling for devices modified as descried in the guidance include, in addition to other elements, a prominent and clear statement for users that results generated by the device are adjunctive (supporting) and should not be solely or primarily relied upon to diagnose or treat COVID-19 associated coagulopathy. Read the Guidance Questions? If you have questions about this guidance, email COVID19DX@fda.hhs.gov.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA