FDA official announcements and publications

FDA Issues Long-Awaited Draft Guidance to Improve Diversity in Clinical Trials for Medical Device Makers

Jun 26, 2024, 02:56 PM

The U.S. Food and Drug Administration (FDA) has issued long-awaited draft guidance to improve diversity in clinical trials. Released six months later than expected, the guidance aims to enhance the representation of racial, ethnic, and other underrepresented groups in clinical studies. This initiative is designed to yield a better understanding of treatment effects, improve clinical trial results, and increase trust and participation among diverse populations. The guidance provides detailed instructions for medical product sponsors and medical device makers on how to submit Diversity Action Plans, which are now required for certain clinical studies.