Letter/Comment

The AHRMM LUC members submitted comments and recommendations to the FDA's Draft Guidance for Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices.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…
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.
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…
AHRMM supports the concept and use of Comparative Effectiveness Research (CER) to provide evidence-based data to help inform purchasing decisions. CER is designed to support healthcare decisions by providing objective conclusions after comparing the effectiveness, benefits, and potential harm of…
This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.