The labeler of a device with a UDI is responsible for submitting information about the device to the Global Unique Device Identification Database (GUDID), a public database that contains important identification information about every device with a UDI. In order to ensure data quality, FDA has taken steps to make correcting errors by editing device records easier.
Previously, unlimited edits were only possible during the 30 day grace period following initial publication. After the grace period, edits could only be made through a difficult process. Now, the GUDID Coordinator user has the ability to “unlock” device records. Once previously submitted device records have been unlocked, errors may be corrected. It should be noted that the records’ history will be saved and the public will be able to see what edits have been made.
