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.
- Date, Time and Location
- Federal Register Notice
- Webcast
- Agenda
- Registration
- Contact Us
- Discussion Paper
FDA Campus Information
Webcast
To view the webcast, please follow the instructions below:
- Turn-off Pop-up Blockers
- Must have Adobe Flash Player
- Ensure that your firewall allows connection
** If you are still unable to connect to the webcast, please contact your IT Support **
Webcast Link: https://collaboration.fda.gov/ptinr/
The CDRH PT/INR working group will be accepting electronic comments during the workshop.
Submit comments to: [email protected]
If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview.
Join the conversation on Twitter at #PTINRFDA
[email protected].
For questions regarding workshop content please contact:
Rachel Goehe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5533, Silver Spring, MD 20993, 240-402-6565, email: [email protected].