Leveraging Real-World Evidence for Pediatric Medical Device Label Expansion: A Case Study in Surgical Cryoanalgesia
Author / Expert
Alberto Jarrin Lopez, Amartya Dave, Sunghoon Kim, Benjamin E. Padilla, Usha Thekkedath, Alyssa Abo, Michael Harrison, Hanmin Lee
Topic overview
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].
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