Academic Journal
Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices.
| Title: | Ethical concerns regarding a lack of standardized clinical demographic data: an audit of 2023 FDA medical devices. |
|---|---|
| Authors: | Whitehouse E; Department of Communication, Drexel University, Philadelphia, PA, USA., Swain M; Independent Scholar, Philadelphia, PA, USA., Shumar W; Department of Communication, Drexel University, Philadelphia, PA, USA. |
| Source: | Expert review of medical devices [Expert Rev Med Devices] 2026 Jun; Vol. 23 (6), pp. 707-712. Date of Electronic Publication: 2026 May 18. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 101230445 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1745-2422 (Electronic) Linking ISSN: 17434440 NLM ISO Abbreviation: Expert Rev Med Devices Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2015- : Abingdon, Oxford : Taylor & Francis Original Publication: London : Future Drugs Ltd. |
| MeSH Terms: | United States Food and Drug Administration* , Equipment and Supplies* , Device Approval* , Demography*, United States ; Humans ; Female ; Male |
| Abstract: | Introduction: 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. Methods: The N = 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. Results: 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. Conclusion: More stringent guidelines are needed for reporting demographic data with medical devices, which may lead to increased patient safety and personalized medicine. |
| Contributed Indexing: | Keywords: Food and Drug Administration (FDA); Medical devices; device approval; diversity; equity; subgroup analysis |
| Entry Date(s): | Date Created: 20260507 Date Completed: 20260716 Latest Revision: 20260716 |
| Update Code: | 20260716 |
| DOI: | 10.1080/17434440.2026.2671943 |
| PMID: | 42095631 |
| Database: | MEDLINE |
| ISSN: | 1745-2422 |
|---|---|
| DOI: | 10.1080/17434440.2026.2671943 |