Device Trial Participation Snapshots
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.
Information Provided In Device Trial Participation Snapshots
Each device trial participation snapshot provides:
- general information about what the device is, how it works, when it can be used, and benefits and risks of use,
- who was represented in clinical studies of new medical technology (demographics including sex, age, race, ethnicity), and
- whether there were any reported differences in the benefits and risks in different groups.
Limitations of Device Trial Participation Snapshots
Device trial participation snapshots are one tool for consumers to use when discussing the benefits and risks of using a device with their health care provider. Do not rely on these snapshots alone to make decisions about medical care.
- Snapshots are not a substitute for advice from your health care provider.
- Snapshots aim to provide consumer-friendly information about the clinical trials supporting approval of new medical devices, including the diversity of participants in clinical trials.
- When known, snapshots include information on how the device worked in different groups of people in the clinical trial. It is not always possible to make conclusions about these differences when evaluating small numbers of participants in a particular group.
Frequently Asked Questions
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.
CDRH recently updated its processes to consistently communicate device trial participant demographic information in publicly available decision summaries for higher risk devices (those regulated under the Premarket Approval, or PMAs pathway). These snapshots reflect recent approvals of certain devices that were authorized since that change. Those changes were made as part of our efforts to provide more transparent and accessible information about medical device clinical trial participation diversity.
CDRH is currently piloting this approach. This website includes device trial participation snapshots for certain recent (April – July 2024) approvals of higher risk devices approved under original premarket approval (PMA) applications. PMA approval is based on a decision by FDA that the PMA contains enough scientific evidence to assure that the device is safe and effective for its intended use(s).
FDA does not anticipate updating snapshots at this time. Device trial participation snapshots include information that was available at the time of approval.
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.
Date of Original Approval | Device Name | FDA Premarket Approval (PMA) Number | Category |
---|---|---|---|
04/17/2024 | Lumicell Direct Visualization System (DVS) | P230014 | General & Plastic Surgery |
05/06/2024 | Esprit BTK Everolimus Eluting Resorbable Scaffold System | P230036 | Cardiovascular |
06/06/2024 | Lacrosse NSE ALPHA Coronary Dilatation Catheter | P230026 | Cardiovascular |
06/08/2024 | Cordella Pulmonary Artery Sensor System (CorPASS) | P230040 | Cardiovascular |
07/02/2024 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System | P220030 | Ophthalmology |