This NEST Test-Case transforms the concept of RWD to a real-life application for intervertebral body fusion devices.
Dr. Ronald Jean, FDA, closed the presentation by highlighting the importance of this Test-Case to the future of post–market surveillance for medical devices: “This study was intended to evaluate whether real-world evidence could enhance device post–market surveillance, and there was no outstanding safety or effectiveness question related to the devices in this Test-Case. While the generation of real-world data holds multiple applications where data collection is reliable and relevant, in this case the results may serve to validate the safety and effectiveness of the devices under study, as well as lead to labeling changes, or serve as surrogate data for other marketing applications or device refinements down the road.”
Thank you to the experts who joined us for this conversation on the feasibility of using RWD to assess the safety and effectiveness of medical devices. We look forward to continued conversation and collaboration on important issues to the medical device ecosystem.