A comprehensive overview of real-world evidence in medical device approvals in the United States

Despite the U.S. Food and Drug Administration (FDA)’s recognition of the value of real-world evidence (RWE) in the evaluation of medical devices, there is a lack of consensus among RWE stakeholders regarding the FDA’s specific evidentiary requirements. This paper reviews the publicly accessible FDA approval documents from January 2020 to July 2024 and describes the intended purpose of RWE incorporated into medical device approvals, i.e. to support claims of safety and/or effectiveness and its impact on the FDA’s benefit-risk assessment. Between January 2020 and July 2024, 117 medical devices included RWE in their submissions. Of these, 74 (63.25%) used RWE to support approval, while in 43 (36.75%) submissions, an RWE study was requested by the FDA. The most common submission types were 510(k) and Pre-Market Approval (PMA)-Panel Track (27.4%), followed by PMA-Original (21.9%) and De Novo (19.48%). RWE most frequently supported effectiveness (85.24%), safety (72.97%). Cardiovascular devices accounted for 44% of approvals incorporating RWE, with registry-based studies being the most common data source. This review highlights key areas of FDA feedback on RWE studies, including concerns related to methodology and data quality emphasizing the need for careful selection of real-world data and rigorous study design.