Yes, based on our preliminary review of the draft GUDID Guidance. Although more specific information will likely be provided by your GDSN-certified Data Pool once the guidance is finalized, the expected process is:
- The labeler would designate their GDSN-certified Data Pool as a “third-party submitter” authorized to submit data to the GUDID on the labeler’s behalf.
- Then, the labeler would register their UDI product data with the data pool and instruct them to submit the product data on their behalf to the GUDID.
- The Data Pool would then convert the GDSN message to the FDA-required HL7 Structured Product Labeling (SPL) format, and register the data with the FDA GUDID.
