Hi Anon
The best guidance may be in the FR notice for the UDI rule.
https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system
It says clearly that a convenience kit is a device in its own right and subject to the rule. I take that to mean that the same exemptions that apply to any other device apply to kits, so if the kit itself is GMP exempt, then it needs no UDI.
It is true that devices within a UDI-labeled convenience kit are exempt from being labeled with their own UDIs, but that is only one of many exemptions. If those devices are GMP exempt, already no UDI is required. If they were not GMP exempt, and a UDI would otherwise be required, then the kitting would exempt them. Kitted GMP exempt devices are doubly exempt from the UDI requirement. Although of course you can still label them with UDIs if you think it might be convenient for you or your customers.
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Anne LeBlanc
United States
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Original Message:
Sent: 14-Mar-2023 09:42
From: Rajeswari Devanathan
Subject: UDI for Convenience kit with two GMP exempt Devices
Hi,
21 CFR 801.30(d), the UDI of a class I device is not required to include a production identifier for a convenience kit. DI is required though for DI record in the GUDID.
Reference from attached guidance - attached
The convenience kit is itself a device. The UDI of the convenience kit must include any PIs on the convenience kit label that are required by 21 CFR 801.40(b), unless an exception15 or alternative applies.
15 For example, pursuant to 21 CFR 801.30(d), the UDI of a class I device is not required to include a production identifier
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
Original Message:
Sent: 13-Mar-2023 19:28
From: Anonymous Member
Subject: UDI for Convenience kit with two GMP exempt Devices
This message was posted by a user wishing to remain anonymous
I have come up with a product that will be packaged as a convenience kit with two Class 1, 510(k) and GMP exempt devices. As GMP exempt devices, they are exempt from UDI requirements. However, there does not seem to be an exception for not placing a UDI on the convenience kit of these devices. The only exception is for the devices in the package if the kit has a UDI.
The Interim Guidance for Convenience Kit provides for Enforcement discretion for 510(k) registration, but not for GMPs.
It does not seem reasonable or logical that the kit that contains two GMP exempt, UDI exempt devices require a UDI. However, I cannot find where this might be clearly stated and can see someone expecting a kit to have a UDI anyway.
BTW, the devices are both provided and used non-sterile, are reusable, but are single patient use.
Does anyone have a specific example, precedent, guidance of statement from FDA that would add clarity.
Thanks