UDI (Unique Device Identification): HIBCC or GS1?

[Edward Reesor]

I received an email about a FDA Webinar on UDI and Convenience Kits. Would your issue involve the same questions?

​

I have cut and pasted the information below. I had to remove the hyperlinks so you may have to search to actually view the webinar.

​

Reminder: May 21 Webinar - Unique Device Identification: Convenience Kits Final Guidance

On Tuesday, May 21, 2019, from 3:00 p.m.-4:30 p.m. EDT, the FDA will host a webinar to share information and answer questions regarding the implementation of the “Unique Device Identification: Convenience Kits” final guidance. Registration is not necessary.

The final guidance, “Unique Device Identification: Convenience Kits,” describes FDA’s interpretation of the definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements only.
Webinar details:
Date: Tuesday, May 21, 2019
Time: 3:00 p.m.-4:30 p.m. EDT

Registration is not necessary.

To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.

NOTE: You must dial-in to hear the presentation and ask questions:

U.S. Callers:
1-800-857-5152
Conference number: PWXW8968316
Passcode: 1273630
International Callers:
1-212-547-0162
Conference number: PWXW8968316
Passcode: 1273630
Following the webinar, a transcript, recording, and slides will be available at www.fda.gov/CDRHWebinar.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.


Questions?
If you have questions about this final guidance, contact the UDI Help Desk.

​

U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)​

 

[aureom38]

Thanks for your reply but it's more a question for HIBCC. I can't call because I'm in France

 

[aureom38]

If someone here uses the HIBCC UDI, I would like to know what software it uses to produce the codes automatically at the factory.

 

[LCordie]

You shouldn't create a new UDI-DI for each serialized product. The UDI-DI is assigned to the part number and the serial number is encoded into the UDI-PI (production identifier) at time of printing. This primary UDI-DI is what is entered into GUDID

 

[aureom38]

Yes I'm ok but in the UDI of HIBCC you have the check character that change for each UDI because the PI change for each products.(because is not the same serial number). I wanted to know if there is a way to calculate it automatically when the label is printed.
At time of printing to generate UDI do you use a software provide by HIBCC or you created your own software ?

 

[Ronen E]

I can't call because I'm in France

This sounds a little strange in the 2nd decade of the 21st century

 

[aureom38]

This sounds a little strange in the 2nd decade of the 21st century

It was 10:00 PM in France and it cost a lot to call in US

 

[RL-WANG]

I'm not able to post the document here nor put up the link yet, please browse to IMDRF webpage www imdrf org and look for IMDRF Documents.
The latest version (21 March 2019) is available for a complete guideline on Unique Device Identification system (UDI system).

 

[RL-WANG]

I'm not able to post the document here nor put up the link yet, please browse to IMDRF webpage www imdrf org and look for IMDRF Documents.
The latest version (21 March 2019) is available for a complete guideline on Unique Device Identification system (UDI system).

The direct link is Documents

 

[CPhelan]

With regards a clinical trial, is a UDI required or is it acceptable to have the EU MDD/FDA requirements on the labels?