U.S. FDA Publishes Final Rule on UDI
The US FDA UDI Final Rule on the establishment of a Unique Device Identification System for medical devices was published in September 2013. The rule, with some exceptions requires medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI).
The system, comprised of:
- the UDI code
- application of the UDI to device labelling and packaging, and
- a related database (Global Unique Device Identification Database or GUDID)
will provide a standardised way to identify devices across all information sources and systems, including electronic health records and devices registries.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.