07 Jun FDA UDI Requirements for Convenience Kits
The Unique Device Identification system is used to identify the device throughout its distribution and use on the market. This system enables efficient post-market surveillance for medical device companies as well as for the FDA. FDA released a final guidance in April 2019 redefining the Unique Device Identification requirements for convenience kits.1
According to the FDA, convenience kits themselves are medical devices. The term “convenience kit” is defined in 21 CFR 801.3 as “two or more different medical devices packaged together for the convenience of the user.” Individual devices packaged within the immediate container of a convenience kit are excluded from the UDI labeling requirements of 21 CFR 801.20, provided that a UDI is on the label of the immediate container of the convenience kit (21 CFR 801.30(a)(11)).1
FDA does not consider every medical procedure kit nor every collection of two or more medical devices to be a convenience kit. Medical Procedure Kit: A medical procedure kit typically consists of one or more medical devices, packaged together to facilitate a single surgical or medical procedure. A medical procedure kit may be a convenience kit.1
Manufacturers will have to requalify their convenience kit classification and reassess if the new UDI requirements apply to them. For qualifying convenience kits only, the package is required to bear the UDI label and not the individual devices; however, if the manufacturer wants to market the individual devices in order to replenish the convenience kit, the individual devices must bear a UDI.
As far as single-use disposable medical procedural kit goes, the kit itself is required to bear a UDI and not its individual components. Since the contents of a single-use convenience kit are packaged sterile, and even if there are any unused contents, it is disposed of because the sterility would be compromised.
FDA’s guidance “Unique Device Identification: Convenience Kits” issued on April 26, 2019 provides a clear explanation of the definition of a convenience kit. Interpretation of terms provided in this guidance may mean that fewer medical procedure kits are considered to be convenience kits, and thus are required to bear a UDI.1
If you are unsure whether your medical procedure kit qualifies as a convenience kit, or whether your product must comply with the UDI regulatory requirements, give us a call at 248-987-4497 or email us at firstname.lastname@example.org.
1FDA (April 2019) Unique Device Identification: Convenience Kits retrieved on 05/29/2019 from https://www.fda.gov/media/95120/download