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Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices
Journal article   Peer reviewed

Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices

Emma Whitehouse, Marianne Swain and Wesley Shumar
Expert review of medical devices, Forthcoming
07 May 2026
DOI: https://doi.org/10.1080/17434440.2026.2671943
PMID: 42095631
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Abstract

device approval diversity Food and Drug Administration (FDA) subgroup analysis equity Medical Devices
Medical devices have been regulated by the Food and Drug Administration since 28 May 1976. The FDA does not currently require that medical device companies publish diversity data across all device approval pathways. Demographic information is imperative because it enables stakeholders to note the safety of medical devices with different demographic groups. The aim of this article is to quantify the demographic information publicly available on the FDA's 2023 Device Approvals page. The  = 52 medical devices available on the FDA's 2023 Device Approvals page were analyzed via qualitative coding with two coders and then checked for intercoder reliability using Cohen's Kappa. Of the medical devices on the webpage, only 59.6% reported all demographic variables included in the study (gender/sex, race, ethnicity, and age). Sex/Gender was reported 92.3% of the time, Race 75% of the time, Ethnicity 61.5% of the time, and Age 94.2% of the time. More stringent guidelines are needed for reporting demographic data with medical devices, which may lead to increased patient safety and personalized medicine.

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