JAMA Network – December 16, 2020 -Madris Kinard, MBA; Lisa McGiffert, BA
Tracking Medical Devices With the US Food and Drug Administration’s Unique Device Identification System
In 2007, Congress mandated that medical device manufacturers create a unique identifying number for each of their products that was similar to a vehicle identification number on automobiles.1 Work to implement the law did not begin until in 2012, when Congress added a deadline. In 2013, the US Food and Drug Administration (FDA) adopted the final rule.2
Currently, device manufacturers must include a unique device identifier (UDI) on the label of all implantable and life-supporting/life-sustaining medical devices. By September 2022, the UDI will also be required for lower-risk, nonimplantable devices. The UDI is meant to be readable by people and also scannable; it contains up to 62 data elements, such as the company name, device name, and model number.3 This information is stored in the Access Global Unique Device Identification Database (AccessGUDID), a free, publicly available database maintained by the FDA.