The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) is launching a pilot program to help speed the release of news and information regarding potentially high-risk medical devices.
The FDA’s pilot program will provide both consumers and industry with early alerts regarding the recall of potentially high-risk medical devices used in connection with cardiovascular, gastrorenal, obstetrical or gynecological, and urological issues. The goal of the pilot program is to minimize the time between when the FDA becomes aware of a potential device safety concern and the communications from the agency to the public regarding the safety concern.
The pilot program follows recommendations from the Patient Engagement Advisory Committee (PEAC) on how the FDA’s recall efforts could be enhanced to reduce the time between FDA awareness of device-related risks and the communications with the public about those risks, their potential impact and actions that can help minimize those risks.
More information about the FDA’s pilot product recall program is available at https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-communications-pilot-enhance-medical-device-recall-program.
