Testimony Before the FDA Workshop on Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy
Two overarching problems are highlighted by the INRatio/ROCKET AF case: (1) The inadequacy of the low Food and Drug Administration (FDA) legal standard of substantial equivalence [510(k)] for devices needed to monitor life-threatening conditions; and (2) The dangerous failure of parties involved — the FDA, the Rocket AF investigators, Janssen/Bayer, and the INRatio manufacturers — to promptly investigate, communicate serious device warnings to all other parties, and take appropriate, necessary actions.