FDA UDI System Status

August 12, 2015 Andrew Pfeifer

The FDA announced this morning that it has identified a security vulnerability in its UDI database system, GUDID. While a patch to fix the vulnerability is being developed, the FDA has decided to take the system offline. This applies both to the Production and Pre-Production GUDID environments. The FDA has stated it does not anticipate “full functionality to be available until at least August 20, 2015.” Reed Tech has requested clarification from the FDA regarding the details of the system’s unavailability.

While the GUDID downtime is disruptive to many companies’ UDI compliance plans, we would like to remind you that the Reed Tech UDI system remains online and available for use for all functions prior to the submission of device records to the FDA.

This means that, during the GUDID downtime, Reed Tech customers using our Software-as-a-Service UDI system can still:

  • Set up user accounts 
  • Test data imports
  • Perform User Acceptance Testing and User Training
  • Import and clean up production data per the latest available version of FDA business rules
  • Build SPL files

Reed Tech customers operating in our outsourced services model can continue to have Reed Tech:

  • Import and clean up production data per the latest available version of FDA business rules
  • Build SPL files
  • Assist in fixing any data validation problems

The FDA has indicated that it may be able to restore the ability to accept GUDID submissions in SPL format sooner than full system functionality.

As always, Reed Tech UDI experts are available to answer questions regarding this or other UDI issues.

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