Kristina,
Yes, that is one way to arrange UDI numbers across the product range. It really depends on the product, configurations available, sizes, components, etc. As example, worked on a cranial implant that was made out of same material, same processing, same sterilisation, but every device was different based on customer needs. If I remember there was 4 or 5 UDI for the sizes from small to large - while the actual device was configured for the patient's injury. In reality the UDI-DI did not make so much difference because the UDI-PI was most important because it was individually serialised for each patient.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Dec-2018 11:42
From: Kristina Cook
Subject: UDI for customized device
Thank you Anne and Richard!
I reviewed the GS1 section on configurable devices; any idea what companies do that have patient specific devices? For example, devices created based off patient specific anatomy? Perhaps a range of possible sizes (from the smallest to the largest known anatomy) could cover all variations.
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Kristina Cook
San Francisco CA
United States
Original Message:
Sent: 16-Dec-2018 09:44
From: Richard Vincins
Subject: UDI for customized device
Configurable, special order, or customised products can be a bit challenging for UDI. Anne is correct that GS1 has some guidance and tips how to manager that along with the FDA regulations do not really get into those specifics. I have usually recommended to use a bit of grouping when it comes to special or customised products. For example, you can have the "main" product that has UDI 12345678 that in the product description all of the variations or flavours are listed. Sometimes assigning a UDI number to each and every variation can be daunting if not impossible. If you use a base/main product to assign your UDI even if there can be slight variations that might work, though I have inquired with FDA who cited the regulation back to me ... not helpful ! As an example, say you have product 'X' that can have component 1 2, or 3 on it and then component 4, 5, or 6, and finally come in a variation of A or B, then you can think of all the possibilities - and of obtaining UDI numbers. Therefore, only product 'X' gets a UDI number although in the product description you could list different components that could be an option for the customer.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 15-Dec-2018 18:34
From: Anne LeBlanc
Subject: UDI for customized device
Hi Kristina
If you're using GTINs, there's a bit of information in the GS1 document on GTIN allocation rules for healthcare, about configurable medical devices. It's similar to the approach defined in the European MDR for configurable devices and device configurations. I haven't seen much in the FDA documentation other than the general rule that if it's a new version or model then it needs a new UDI.
Best,
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 14-Dec-2018 11:50
From: Kristina Cook
Subject: UDI for customized device
Hello,
I was wondering if there are any guidance documents for creating UDIs for customized (not custom) devices.
Thanks,