The FDA is collecting UDI information on PMA approved, 510(k) cleared, 510(k) exempt, and Unclassified devices in the GUDID repository. To ensure a GUDID Account is created for an actual device labeler the FDA requires one Premarket number or a Listing Number be provided in the GUDID Account Application Form (version 8).
"FDA Premarket Number: Please provide one valid FDA Premarket Number (PMA, 510k, etc.) for a device currently marketed in the U.S. If 510k exempt, provide the FDA Listing Number instead."
It appears this is your first device marketed in the U.S., so you need to wait for the cleared 510(k) number before creating your GUDID account. In the meantime, you can prepare your product identification standard/code and collect the (57) data attributes that need to be submitted to the FDA GUDID. Be glad to discuss the details.
Regards, Gary Saner
gsaner@reedtech.com, www.Reedtech.com------------------------------
Gary Saner
Sr Mgr Information Solutions Life Sciences
Horsham PA
United States
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Original Message:
Sent: 05-Nov-2018 12:51
From: Magdalena Corral
Subject: UDI & GUDID
To be able to submit information to US FDA GUDID you will need to have 510K number. System will not accept information about the device if you do not fill required field, and 510K number is one or mandatory fields.
You can create account and do all of necessary preparation work for data submission while waiting for 510K clearance.
That way at the time of obtaining clearance you are ready for data submission.
Remember you can not place item on the US market if not UDI compliant: meaning labeled with UDI bar code and successfully passed submission to GUDID.
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Magdalena (Becky) Corral
QA RA Manager
Kennewick WA
United States
Original Message:
Sent: 02-Nov-2018 07:42
From: Matt Dodd
Subject: UDI & GUDID
I contacted FDA's UDI Help Desk with a similar question back in July, and was told that:
"... you will need to either submit a premarket number for an approved device for which you are required to submit data to GUDID, or wait until your device is approved to contact us again. GUDID is for FDA approved or cleared devices."
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Matt Dodd
Regulatory Affairs Specialist
Cambridge
United Kingdom
Original Message:
Sent: 01-Nov-2018 07:12
From: Richard Vincins
Subject: UDI & GUDID
You can obtain a GUDID account at any time and start populating. Whatever information you have can be entered later - or as expected by the regulation, information in GUDID should be updated when changes occur.
In the actual 510(k) submission, you can either make a commitment to getting a UDI and leave a "box" on the label for the UDI as mentioned. Or if you already have the DI information, would recommend including that in the 510(k) submission in a table for each model or version of device.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 31-Oct-2018 17:28
From: Bhupinder Singh
Subject: UDI & GUDID
No steps needed to implement before 510(K) for UDI. Only action required from you is that you have to have an empty space on the draft label where the UDI will go before commercialization and on the empty space write place holder for UDI. This is what I did in my previous 510(K) submission and FDA did not have any question or need additional information in regards UDI
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Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
Original Message:
Sent: 31-Oct-2018 15:57
From: Anonymous Member
Subject: UDI & GUDID
This message was posted by a user wishing to remain anonymous
Hello RA folks,
We are a Medical Device manufacturer based out of US. We are preparing our first 510(k) submission and evaluating the implementation of UDI as a part of the requirement.
I noticed as a part of the GUDID Data Element we have to submit FDA Premarket Submission Number information. Does that mean that we can request GUDID account and enter device data into GUDID only once the 510(k) gets cleared?
What steps of UDI implementation should be completed before 510(k) submission?
Any guidance is appreciated!
Thanks!