Optimizing Use of Real-World Data in Regulatory Decision Making for Medical Devices Used in Surgical Procedures.

Abstract

In the United States, the Food and Drug Administration has provided guidance on the contexts in which real-world evidence (RWE) can be used to support regulatory decisions for medical devices. In this paper, we review different sources of real-world data (RWD) for medical devices used in surgical procedures and how to optimize the design and analysis features of RWD studies to maximize the strength of RWE. The design and analysis of a study are critical to ensuring that the RWE generated from th