First, I want to make sure that I answer the question you ask. For me, the variable information is the value of the production identifiers (PIs) on the label, such as lot or batch number.
In GUDID, you do not enter the values of the PIs. You only enter an identification of whether or the label uses a given PI. For example, if your label includes the lot number, you add it to AIDC portion of the label and tell GUDID that you use a lot number, i.e., YES. You do enter any lot numbers into GUDID.
FDA has an Excel file that has the structure of the data to submit. You will see there is only a “check box” for lot number – there is no place for the actual lot numbers.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 04-29-2016 11:08
From: Valeria Sena-Weltin
Subject: GUDID (variable information) How often we need submit it to FDA
Good morning,
I would like clarification on the submission of variable information to FDA.
In the last GUDID webinar offered by the FDA, I specifically asked the speaker how often the manufacturer will need to submit the variable information to FDA through the GUDID account, and I was told that we only submit the device information once, when we list the device in the GUDID account with its GTIN and every time there is a change on the device/device ID thereafter. However, I just finished a conference call with the regulatory group of one of our contract manufacturer and they are certain that it is necessary to submit the information to FDA for every lot manufactured.
Can anyone share with me their understanding and current experience in this topic?
Thanks,
Valeria
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Valeria Sena-Weltin, M.S., RAC(US)
Regulatory Affairs Specialist
Gaithersburg, MD
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