Real-world data (RWD) can be collected from a diverse array of sources, such as electronic health records, registries, administrative claims, pharmacy data and feedback from wearables and mobile technology. These data offer opportunities to generate evidence and better understand clinical outcomes. In support of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) mission to protect and promote public health by ensuring the safety and effectiveness of medical devices, while assuring patients have timely access to them, CDRH aims to foster the use of real-world evidence (RWE) to support regulatory decision-making. To further this goal, by developing a more complete understanding of RWE usage, CDRH has reviewed a sample of past decisions to identify examples leveraging RWE in premarket and postmarket decisions. We selected a set of 90 examples of submissions that illustrate the broad spectrum of RWE usage in support of regulatory decision-making from fiscal years 2012 through 2019.
The 90 examples come from the full continuum of clinical and device areas throughout all seven Offices of Health Technology in CDRH and across the medical device total product life cycle. These examples represent:
This report is organized into six sections separated by device type (therapeutic devices, in vitro diagnostics) and RWD source (Registries, Administrative Claims Data, Medical Records, Other Sources).
The examples demonstrate a diversity in the usage of RWE, where:
This report also includes examples from areas where innovative device technologies are being developed.
Finally, four studies leveraged RWD sources to abstract radiographic imaging data to address endpoints, and one example is included for a peripheral vasculature imaging device that utilized a clinical trial embedded in a national registry, with enrollment, randomization, and data collection conducted through the registry platform to support a premarket decision.
CDRH strongly encourages the continued and expanded use of RWE to provide new insights into the performance and clinical outcomes associated with medical device use over the total product lifecycle. Manufacturers planning to seek marketing authorization for devices are encouraged to consider RWE early on and communicate with FDA, as needed, to understand how to best utilize the RWE to support the marketing claims. Successful applications of RWE are most often achieved when principles of relevance and reliability are considered, as detailed in our guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. We are actively engaged with the medical device stakeholder community to address challenges and advance the science of RWE generation, through the establishment of the National Evaluation System for health Technology, or NEST, which is integrating data from clinical registries, electronic health records, and medical billing claims to gather more comprehensive evidence of medical device safety and effectiveness while seeking to reduce the time and cost of RWE generation.
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