CDRH Pilot Program Aims To Speed Up Device Recall Notifications

FDA’s Center for Devices and Radiological Health (CDRH) is initiating a pilot program that aims to provide swifter communications about corrective actions taken in response to high-risk recalls, the agency said Thursday (Nov. 21). Those actions may include products being removed from the market, correction of products or updated instructions for product use. The pilot program will focus on high-risk devices in the areas of cardiovascular and gastrorenal medicine, general hospital devices, obstetrics and gynecology, and urology. It will provide...