FDA Exploring Challenges Associated with POCT PT INR Devices

On March 18, the Food and Drug Administration (FDA) is conducting a public workshop on “Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy,” which will examine the scientific and regulatory challenges associated with analytically and clinically validating POC PT/INR in vitro diagnostic devices.  The goal of the workshop is to identify potential solutions to these challenges that will improve the clinical management of warfarin therapy. 

The FDA has identified a number of topics for discussion at the workshop, such as:

• The current review process for POC PT/INR devices;
• The benefit and risks associated with POC PT/INR devices;
• The technological differences between POC PT/INR devices; and
• Challenges associated with correlating results from whole blood POC PT/INR devices to conventional plasma-based laboratory tests;

The deadline to register for in-person participation is March 10.  The session will also be webcast at https://collaboration.fda.gov/ptinr/.  The FDA is accepting comments through April 18^th.  You can e-mail your comments to [email protected]. 

In addition to sending your comments to the FDA, please forward a copy to Vince Stine, PhD, AACC's director of government affairs, so that the association’s Government Relations Committee can consider your thoughts when drafting AACC’s response.