10 years of the FDA's Unique Device Identification (UDI) requirement
23 November 2023
Deniz Bruce, CEO of the GMDN Agency, said: “We are publishing this guest article and video from AIM (Automatic Identification and Mobility) North America to celebrate the 10 year anniversary since the FDA’s Unique Device Identification (UDI) requirement first took effect. GMDN has been a proud partner and supporter of the UDI journey since 2013 and we congratulate the FDA on reaching this milestone anniversary.”
September 23, 2023, marked the 10-year anniversary of the day the FDA’s Unique Device Identification (UDI) requirement first took effect. For many UDI pioneers and leaders, the date represented a 20-year anniversary since UDI development work began about a decade before UDI became law. In that time, UDI went from an idea to a framework to a law; its GUDID database now uniquely identifies and holds data on more than 4 million medical devices and is the foundation for thousands of daily lookups and transactions. It supports a growing range of use cases in supply chain operations, hospital material management, patient safety and clinical research. UDI set a precedent and serves as a model for similar medical safety and supply chain systems in dozens of countries around the world. The FDA reported that 89 percent of device recall submissions in Q3 2023 included the UDI, double the level from Q1 2022.
UDI’s progress is exceptional, considering where it started, and the many diverse stakeholders involved. Yet many professionals that were most responsible for creating and advancing the UDI system are not celebrating these accomplishments but instead are focused on moving the program forward.
“Over the last 10 years, a lot of progress has been made,” says Indira Konduri, who is deputy Director of Division of Surveillance Support within the FDA’s Center for Devices and Radiological Health (CDRH), and is leading UDI implementation for the Center. “The good news is that the infrastructure the UDI system needs is in place. Now we’re doing a lot of exciting work leveraging this infrastructure and utilizing UDI to meet the intent of the UDI rule.”
You can read the full press release here.