A review of 90 medical device and diagnostics submissions that used real-world evidence or real-world data shows that RWE/RWD can be a powerful tool to not only better understand how products work outside the clinical trial setting, but also get treatments to patients faster, the US Food and Drug Administration says.
Over the past few years, the agency has heavily touted the benefits of using RWE to medtech sponsors at various forums and even developed the National Evaluation System for Health...