The FDA’s Center for Devices and Radiological Health (CDRH) is piloting this approach to help address questions about who participated in clinical studies of new medical technology and what clinical trial information is available about how it works in different groups of people. This is part of an overall FDA effort to increase transparency around clinical trial participation diversity in studies of novel medical products.

Enhancing diversity within clinical studies facilitates broader applicability of results across a broad spectrum of patient populations. It also enhances understanding of the disease or medical device under study and helps inform the safe and effective use of the device in patients.

The FDA seeks comments from the public on the device trial participation snapshots. Submit comments to www.Regulations.gov under docket number FDA-2024-N-4561. The last day to submit comments is January 13, 2025.