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GUDID Open for Implant/Life Supporting/Life Sustaining Device Labelers on January 26th, 2015

With the deadline for UDI compliance quickly approaching (Sept 2015 or Sept 2016 according to the FDA extension list), the FDA began accepting GUDID account requests from labelers of implantable, life-supporting, and life-sustaining medical devices on January 26, 2015. 

An account is required for all labelers, regardless of data submission option (Web interface or HL7 SPL). Labelers are strongly encouraged to prepare for GUDID before they request an account. Click here to learn more about this process.

Further clarification regarding the information that is required to be reported to the GUDID can be found in the GUDID Data Elements Reference Table. Information about the Health Level 7 Structured Product Labeling (HL7 SPL) submission option is also available on the FDA website