The FDA's Center for Devices and Radiological Health announced a pilot program designed to improve the timeliness of communications regarding high-risk medical device recalls.
The initiative aims to provide earlier notifications about corrective actions, including product removals, corrections, or updates usage instructions for devices posing significant safety risks, according to an Nov. 21 news release from the agency.
The pilot program will focus on recalls related to devices in specific areas such as cardiovascular, gastrorenal, general hospital, obstetrics, gynecology and urology. It is intended to reduce the time between the FDA's initial awareness of a potential safety issue and the public notification of that issue.
The FDA emphasized that the pilot program will not affect the communication timelines for recalls in other device categories.