Unique Device Identifier App

Executive Summary

The Food and Drug Administration (FDA) now requires that most medical device labels include a unique device identifier (UDI) that can be scanned. Unique device identification enables a device to be identified through its entire journey from manufacture to patient bedside. The device’s UDI and other key information is housed in the Global Unique Device Identification Database (GUDID) and is publicly available on the AccessGUDID website. Inspectors visiting device manufacturing facilities have very limited time and no way to verify in the field that a device label is compliant with the UDI Rule and consistent with data on AccessGUDID, and thus enforce the regulation. An even larger concern is that unreliable UDIs threaten the voluntary adoption of UDI by health care providers and members of the health care supply chain. UDI must demonstrate its value before it will be embraced by these participants, yet these players are crucial to the success of UDI. Without voluntary UDI implementation, the benefits of the system will not be actualized. This team seeks to enable FDA investigators visiting device manufacturing facilities to verify while in the field that a UDI on a device label is scannable and accurate.

A project supported by the: HHS Ignite Accelerator

Team Members

Heather Valadez (Project Lead), FDA
Linda Sigg, FDA
Terrie Reed, FDA

Milestones

January 2017: Project selected into the HHS Ignite Accelerator
February 2017: Time in the Accelerator began