Early Feasibility Studies in the Electrophysiology Space

MDIC is advancing Early Feasibility Studies EFS for medical devices, with a current focus on electrophysiology (EP), to streamline early-stage clinical trials in the United States. Over the past 18 months, MDIC has brought together the FDA, medical device manufacturers, and clinicians to facilitate these studies and tackle common challenges. This initiative builds on the success of EFS within structural heart applications and aims to extend those benefits to the EP space.

The EFS program encourages early engagement with the FDA, allowing device developers to receive essential regulatory guidance during initial phases. Panelists at the recent roundtable shared positive experiences with the FDA’s responsiveness, which helps companies navigate requirements more efficiently. However, they also highlighted challenges with CMS, particularly regarding patient coverage, emphasizing the need for better communication across all parties involved.

By promoting EFS in various medical fields, MDIC continues to reduce barriers for innovative technologies, accelerating their path to patients and enhancing the U.S. clinical trials ecosystem.