CDRH Industry: Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy, January 25, 2016

The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy.”

The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. The goal of the workshop is to seek and identify potential solutions to address the scientific and regulatory challenges associated with POC PT/INR devices to ensure safety and effectiveness.