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

= 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.ResultsOf 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.ConclusionMore stringent guidelines are needed for reporting demographic data with medical devices, which may lead to increased patient safety and personalized medicine.