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FDA UDI System Status Update: Full Functionality Restored


The FDA announced today that it has restored full functionality for the GUDID. This means that the Pre-production and Production environments of the FDA Web Interface are once again available for use.

This announcement comes after the FDA announced last week that it was taking the GUDID Production and Pre-production environments offline due to a security vulnerability while a software patch was being developed. While it stated at that time it did not expect full functionality to be restored until at least August 20, today’s announcement indicated that the security vulnerability was resolved ahead of projected timelines.

Due to the unexpected downtime of the system, the FDA has announced it will extend the 2015 compliance date one month to October 24, 2015.

The FDA previously restored SPL functionality to the GUDID, allowing labelers to continue making submissions of UDI records to the database in HL7 SPL format while other issues were being addressed.

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