FDA Holding Workshop on IVD for Monitoring Warfarin

December 31, 2015

The FDA is seeking input from stakeholders on potential solutions to address the scientific and regulatory challenges for a certain type of point of care in vitro diagnostic that monitors warfarin.

The FDA will hold a workshop on Jan. 25 to discuss topics associated with prothrombin time/international normalized ratio tests, such as their benefit-risk balance, the current process for clearance and the advantages and limitations of the technology in different devices.

The tests monitor warfarin and provide immediate information to physicians on a patient’s anticoagulation status. They can be used in a physician’s office laboratory, anti-coagulation clinic, patient bedside, hospital emergency department and prescription home use.

Comments will be accepted until Feb. 25. More information is here: www.fdanews.com/12-15-FDA-PTINR.pdf. — Jonathon Shacat