Hi Anon
Generally yes, they need UDIs. In the Federal Register notice of the UDI rule, FDA says,
"There were a number of comments regarding the applicability of the UDI requirements of § 801.20 to combination products with a device constituent part, convenience kits, in vitro diagnostic products, and HCT/Ps regulated as devices.
These products are devices, contain devices, or are regulated as devices, and are therefore subject to the requirements of this rule."
https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-systemOn the other hand, if you are shipping components that are not classified as medical devices or accessories, if they are just spare parts, those don't need UDIs.
And no, you can't use the same UDI for different products. Any SKU you package and distribute needs its own unique identifier. For example, you might have
UDI1 = machine + reagents
UDI2 = machine alone
UDI3 = kit of several reagents
UDI4 = one of the reagents alone
UDI5 = package of 50 reagent kits (UDI3)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identifier-system-frequently-asked-questions-vol-1If you have a kit that contains multiple reagents, it will probably have a lot number of its own, in addition to the lot numbers on each thing within the kit. The lot number or serial number of your package is the "production identifier" attached to the UDI, along with the use-by date.
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Anne LeBlanc
United States
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Original Message:
Sent: 03-Feb-2023 15:45
From: Anonymous Member
Subject: UDI requirement for IVD components
This message was posted by a user wishing to remain anonymous
Hi All,
I have a UDI compliance question:
If I have an IVD class II device with FDA. When shipping just the components - such as standards and controls for the finished goods.
- Does these need to be accompanied by a UDI?
- If yes, can the UDI of finished device (assay that it will be used with) be used or it will need it's own UDI?
- Does it make a difference if it is same lot or different lot for the UDI compliance?
Thank you all and have a nice weekend!