Learning UDI Community
Jan 24, 2022
The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. They recommend that information related to all Class I…
Oct 7, 2021
The UDI-DI Change Communication Process Work Group, a part of AHRMM's Learning UDI Community (LUC), recently released a report analyzing current communication processes and their implications on all stakeholders related to changes to the UDI-DI. Gain a clear understanding of how these changes are…
Oct 7, 2021
The UDI Impacts on Recall Management Work Group, a part of AHRMM's Learning UDI Community (LUC), has released their recommended practices reports that analyzes the barriers and highlights the benefits to patient safety and key stakeholder groups when utilizing the UDI throughout the recall process…
Jan 19, 2021
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
Jul 24, 2020
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).
The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a…
Mar 19, 2019
Read this report on the recommended practices related to the allocation of multiple unique device indicators (UDI-DI) and suggested ways to mitigate the occurrence or negative implication of multiple UDI-DIs.
Download Report