Regulatory Monitoring F
or many years, the US Food and Drug Administration (FDA) has used what is now known as real-world data (RWD) and real-
world evidence (RWE). It does so to monitor and evaluate the post-market safety of approved drugs. Throughout history, RWE has also been used to support effectiveness, albeit on a smaller scale. The FDA defines RWD as “data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources”. Examples might be data derived from electronic health records, medical claims data, product or disease registries, or other sources, such as digital health technologies. The aim of each is to inform on health status.
made modern
Regulators are shifting from reactive oversight to proactive, data-driven surveillance that draws on IoMT device data, electronic health records and patient registries to enable continuous
benefi t–risk monitoring. This evolving model, aligned with EU MDR Article 83 and refl ected in the US FDA’s Real-World Evidence framework, is explored by Ellie Philpotts with perspectives from product developers, legal experts, academics, consultants and industry leaders.
RWE, meanwhile, refers to the “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD”. The FDA’s Center for Devices and Radiological Health has also provided more information on its RWE programme for medical devices specifically. Updated in 2017, this guidance notes that there is “rapidly advancing methodology for generating and interpreting RWD”, and as such it doesn’t “elaborate on the methodological approaches that can be used”. However, it adds, “when reviewing the use of
RWE to support a regulatory decision, the FDA will rely on scientifically robust methods and approaches to determine whether submitted RWE
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