FDA Launches Medical/Dental Device Trial Snapshots
Per the notice below, the United States Food and Drug Administration (FDA) has launched a medical/dental device trial snapshots tool that highlights information about the uses, benefits, and risks of the devices.
Device Trial Participation Snapshots
To provide consumers and health care professionals with key information about clinical trials that supported the FDA’s approval of new medical devices, the FDA’s Center for Devices and Radiological Health (CDRH) is piloting providing device trial participation snapshots to highlight certain information about the intended uses of a device, its benefits and risks, and the diversity of participants in clinical trials for certain new medical devices. Device trial participation snapshots may provide helpful information for an individual’s discussions with their health care provider and decisions about their health care. Providing device trial participation snapshots is part of an overall FDA effort to increase transparency around clinical trials for medical products and diversity in clinical trial participation, and supports CDRH’s overall efforts to advance health equity.
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.
