U.S. FDA announces system to help device recalls
The U.S. Food and Drug Adminstration announced it is taking steps to implement a rule that promises to help quickly and efficiently identify recalled medical devices. The new rule for unique device identification (UDI) systems has the potential to identify problem devices faster, better target recalls, and ultimately improve patient safety.
The UDI system consists of a unique number assigned to the version and model of the device at the time of manufacture, and a publicly available reference catalogue for every device with an identifier.
The new rules are available from the U.S. FDA website and the Federal Register.