FDA Finalizes Guidance on Leveraging Real-World Data for Medical Device Submissions

Overview


Jennifer Geetter, Jiayan Chen, and Shelby Buettner wrote this bylined article on new FDA guidance which shows how the agency can use real-world data (RWD) originally collected for purposes of routine clinical care or billing to support FDA regulatory decisions, and clarifies the criteria by which FDA evaluates RWD to establish the safety and efficacy of certain products.