The use of real-world data to generate RWE for medical devices by industry has become more prominent in recent years, and more attractive to a variety of stakeholders. It is used frequently to understand the use of the device in the larger clinical setting, but more recently it is also being used for regulatory decision making. Over the last few years, the use of RWE for medical devices has evolved for use in pre-approval trials for hypothesis generation, historical or synthetic controls, or supplemental data as part of the investigational device exemption, and post-approval trials for labelling expansion and post-market surveillance, particularly to satisfy the 522-mandate (Section 522 of the Federal Food, Drug, and Cosmetic Act).
In 2016, the signing of the 21st Century Cures Act marked the pivotal moment that the U.S. Food and Drug Administration embraced the modernization of clinical trials and outcome assessments to help accelerate medical product development. Around the same time, the FDA’s Center for Devices and Radiological Health released strategic priorities to increase the use of RWD for generating the types of RWE that can be used in FDA regulatory decision making for medical devices. These included the implementation of the National Evaluation System for health Technology, which leverages RWD to identify safety issues faster and to better understand the risk-benefit profile of devices when used in the larger clinical care setting. Between 2016 and 2017, the Center for Devices and Radiological Health’s strategic priorities accomplishments noted that the number of pre-market and post-market regulatory decisions that used RWE increased by 193 percent.
As RWD and RWE continue to rise in popularity and adoptability, it’s important to understand the benefits and applicability to stakeholders beyond just FDA… Read more.