FDA Proposes Rule to Establish Unique Device Identification System for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a proposed rule, which if finalized, would require most medical devices in the United States to carry a unique device identifier (UDI). Mandated by legislation passed by Congress in 2007, the UDI system is intended to improve the quality of information in medical device adverse event reports, which will help FDA identify product problems more quickly, better target recalls, and improve patient safety. Minimally, each UDI would use a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number, or expiration date. The UDIs will be stored in a public database maintained by FDA, which will allow hospitals and users of medical devices to easily look up information about the device.