FDA has no expectations of how a given company organizes this task, or where in the organization the responsibility lies.
By asking the question about who does the data entry, I infer you are planning to use the web interface. The person who does the data entry is performing an administrative task, and should be knowledge about web interfaces, have accurate and fast typing skills, etc. The initial data load will be a large task. The key to success here includes the project of finding all the data for each part number and packaging configuration. This will be a cross-functional team, since the data won't be in one place.
The maintenance task is small. Once the DI record hits the publish date, there are only a few fields that can be changed.
The more important point is to determine when a device change requires a new DI. This is usually part of design change under 820.30(i). Often the responsibility of determining when a new DI is required and setting up the record are split. The first part will probably be in Engineering group as part of change evaluation.
There is a person responsible to FDA-CDRH for maintaining the GUDID. This requires potential contact with the agency, so it is often in the group that deals with FDA. For a PMA device, think of the GUDID maintenance as another report to FDA. This new "report" is the second part I noted.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 12-05-2014 16:58
From: Nitya Narayanan
Subject: UDI GUDID data entry responsibility
Does anyone know who in general FDA is expecting as qualified people or department to do the data entry in the FDA UDI GUDID database (Class III devices)? are most companies having regulatory department do this OR Manufacturing or other departments?
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Nitya Narayanan RAC
Reg. Affairs Mgr.
Fremont CA
United States
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