FDA urged to speed roll-out of proposed UDI system

The American Hospital Association (AHA) last month applauded the Food and Drug Administration (FDA) for moving forward with a proposed rule on a unique device identification (UDI) system and urged the agency to fully implement the proposed system within three years. "The safety of our health care system will be greatly enhanced by a timely final rule that accelerates the roll-out of the UDI, limits the exceptions to the UDI requirements, and provides enhanced information in the [Global UDI Database]," AHA Executive Vice President Rick Pollack wrote. Among other changes, the letter urges the FDA to require direct marking of all implantable devices and all devices intended for more than one use; adopt an international date standard for device labels to avoid confusion over expiration dates; and ensure that certified electronic health records accommodate UDI and automatic identification and data capture technologies.

»More information