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

Abstract

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 Of the me