This report presents 73 examples of market authorizations from fiscal years (FY) 2020-2025 building on the foundational work presented in the 2021 publication “Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions,” which documented 90 examples from FY 2012-2019, and demonstrated the continued evolution and expansion of real-world evidence (RWE) use in medical device regulatory decision-making across the Center for Devices and Radiological Health (CDRH).
Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD sources include electronic health records (EHRs), registries, administrative claims data, device-generated data, public health surveillance data, clinically annotated biobanks, medical device data repositories, and chargemaster and/or billing data.
These data offer opportunities to generate evidence and better understand clinical outcomes using routinely collected, extant
data outside of traditional clinical studies. In support of CDRH’s 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 RWE to support regulatory decision-making throughout the medical device total product lifecycle.
One way CDRH advances this goal is by systematically reviewing and sharing examples of how RWD have been incorporated into regulatory submissions and supported final regulatory decisions.
To document the growing utilization of RWE and highlight emerging and innovative applications, CDRH reviewed public-facing documentation of regulatory decisions from FY 2020-2025 and identified examples that illustrate the breadth of RWD sources, study designs, and analytical approaches sponsors have used to generate RWE in medical device submissions. The examples span a wide breadth of clinical and device areas throughout all 8 Offices of Health Technology in CDRH