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).

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.