Device trial participation snapshots aim to provide consumers and health care professionals with key information about clinical trials that supported the FDA’s approval of new medical devices. The Center for Devices and Radiological Health (CDRH) is piloting this approach to highlight certain information about the intended uses of the device, its benefits and risks, and the diversity of participants in clinical trials for certain new medical devices. This is part of an overall FDA effort to increase transparency around clinical trials for medical products and diversity in clinical trial participation.

Device trial participation snapshots may provide helpful information for an individual’s discussions with their health care provider and decisions about their health care. This supports CDRH’s overall efforts to advance health equity. We hope this information helps promote continued dialogue on representation of different groups in clinical trials.

CDRH began posting device trial participation snapshots in October 2024 and is seeking comments from the public. The last day to submit comments is January 13, 2025.