Translational Pathways for Cardiovascular Devices – Session V: Current Challenges and Future Direction for Catheter Ablation Development and Iteration: FDA Point of View – Mark Fellman Practice Quiz

Currently in the US there are many approved ablation catheters for persistent atrial fibrillation

Which of the following is incorrect regarding the role of the regulatory agency in innovation?

In evaluating arrhythmia therapy, the FDA allows the synthesizing of data from different sources including clinical registries and electronic health records from both the US and Europe