Leveraging Real-World Evidence for Pediatric Medical Device Label Expansion: A Case Study in Surgical Cryoanalgesia

Real-world evidence (RWE) has emerged as an increasingly critical component in the regulatory development and evaluation of medical devices. RWE refers to analyzed clinical data collected from real-world settings (Real-world data, or RWD), including various sources such as the EHR, insurance claims, and patient-generated data (i.e. wearable devices) among others. RWE can be used prospectively or retrospectively in multiple settings to inform decision-making regarding the usage of a device, improve post-market surveillance, and expedite device innovation [1].