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FDA UDI System Status Update: SPL Functionality Restored


On Wednesday, the FDA announced it was taking the GUDID Production and Pre-production environments offline due to a security vulnerability while a software patch was being developed. We are very pleased to tell you that the FDA announced yesterday that UDI data submissions in HL7 SPL format are once again being accepted. The FDA still anticipates that full functionality for other submission types will not be restored until at least August 20.

This means that, while companies using the FDA Web Interface must pause in their UDI data submission projects to wait for the FDA’s software patch, companies submitting to the GUDID in SPL format, including all Reed Tech UDI customers, can continue to submit their UDI records to the FDA without any further interruption.