FDA Elaborates on Real-World Evidence for Device Submissions

The Center for Devices and Radiological Health (CDRH) has issued a new report providing concrete examples of real-world evidence (RWE) used in premarket and postmarket device submissions.

The use of RWE offers “opportunities to generate evidence and better understand clinical outcomes,” CDRH says in the 183-page report that reviews past decisions to better understand the use of RWE to support regulatory decisions. The review covers submissions with final decision dates from 2012 through 2019.

Real-world data can be derived from a variety of sources, including electronic health records, claims and administrative data, data from product and disease registries, patient-generated data and device-generated data, the agency said.