Unique Device Identification (UDI) Rule

Unique Device Identification, or UDI, was created to assign a unique identifier to medical devices (e.g. heart valves, hip/knee implants, stents). It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. This Act asked for the creation of a Unique Device Identification System and included the following mandates:

  • The label of a device must bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or unless an exception is made for a particular device or group of devices.
  • The unique identifier must allow identification of the the device through distribution and use.
  • The unique identifier must include a lot or serial number if specified by FDA.

The UDI is composed of a device identifier (manufacturer, catalog, reference number, product description) specific to the device model, and a production identifier (lot or batch number, serial number and/or expiration date) for the specific device. The FDA feels a UDI system can improve the quality of information in the FDA Adverse Event Reporting System (FAERS) thus improving patient safety by finding problem devices more quickly.

UDI Rule Compliance Timeline

The FDA is using a phased implementation of the rule’s requirements. Class III devices went into effect on September 24, 2014. Implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the PHS Act went into effect on September 24, 2015. The full compliance date timeline can be found here.

Global Unique Device Identification Database (GUDID)

The FDA has also created a public database—the Global Unique Device Identification Database (GUDID)—to allow interested parties to find information about specific medical devices. It includes the device identifier, description, GTIN (if applicable), and device characteristics. This public database does not include any specific patient information or production identifier data. View the database here.