Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment.

Background: Real-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.

Objectives: To determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.