supports the use of RWD to evaluate cardiac devices.
This Test-Case made significant progress in characterizing the validity of RWD as a tool in label expansion studies. Mark Fellman of the FDA stated, “RWE is an economic way to gather evidence to support regulatory submissions…. I personally have seen increased use of real-world evidence in each of these areas for cardiac devices, specifically for cardiac patient technology. The reason why I’ve seen these increases for publication is that real–world evidence is particularly well–suited for devices intended to treat cardiac arrhythmias.”
The objectives of this Test-Case were to assess the feasibility of using real-world data in the evaluation of cardiac ablation catheters and to validate the data capture process of Class III surgical devices to study the safety and effectiveness outcomes surrounding an indication expansion. Ultimately, this Test-Case demonstrated that it is feasible to use RWD to assess the safety and performance of cardiac medical devices. Based on the progress made in characterizing the validity of the data for label expansion studies, the Test-Case has advanced to Phase Two, where the goal is to translate the feasibility study advances to an actual label change study.