Translational Pathways for Cardiovascular Devices – Session IV: Regulatory Perspective in the Assessment of High-Risk Coronary Lesions – Shawn Forrest Practice Quiz

According to the FDA classification and requirement for clearance or approval of devices, the pressure wire to measure fractional flow reserve (FFR) is considered:

Tool claim (measurement with no association to clinical meaning or diagnosis) for diagnostic devices are not typically validated for diagnostic sensitivity/specificity at clinical decision points

Clinical validation for diagnostic devices requires assessment of sensitivity/specificity