The new solution generates required data in the appropriate format to be submitted to the U.S. Food and Drug Administration’s Global UDI Database, a requirement of the UDI rule. The solution also tracks FDA response to each submission. Additionally, the solution can pre-validate GUDID submissions according to the FDA’s specifications, allowing manufacturers to address any issues prior to final submission, according to a GHX news release.
More Articles on the UDI Rule:
Drug Supply Chain & Security Act Implementation Timeline
HSCA Files Comments on DSCSA With FDA
GS1 Healthcare US Releases UDI Implementation Guide
