June 28, 2021 RWD/RWE

Devices: Real world data for premarket and post-market usage

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.

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.

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:

  • RWE served as the primary source of clinical evidence in submissions for new devices and expanded indications for currently marketed devices
  • Prospective, randomized trials were nested within RWD sources
  • Control arms and objective performance goals were generated for evaluating performance of the next generation of devices
  • Registry infrastructure addressed important premarket and postmarket needs
  • Diverse RWD sources were, at times, combined to generate RWE

FDA currently defines real-world data (RWD) as the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can be derived from a variety of different sources, including electronic health records (EHRs), claims and administrative data, data from product and disease registries, patient-generated data, and device-generated data. Real-world evidence (RWE) is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.

RWD on patients’ experiences with medical devices are regularly collected for non-regulatory purposes during routine care and treatment. FDA recognizes that this resulting wealth of RWD can be leveraged to deliver further understanding of the performance, clinical outcomes, and benefit-risk profiles related to medical device use and to reduce the resources required to generate the necessary clinical evidence to support medical device submissions and fulfill postmarket surveillance requirements.

If RWD are reliable and relevant to the regulatory question at hand, they may be considered valid scientific evidence supporting both premarket and postmarket regulatory decisions made by the FDA.

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