UDI requirements for “Convenience Kits” revised by FDA

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UDI requirements for “Convenience Kits” revised by FDA

The US FDA has changed the definition of “convenience kits” -two or more medical devices packaged  together- in terms of Unique Device Identification (UDI) requirements.

According to the new draft guidance, a convenience kit consists of two or more devices sold in a single package for convenience; no additional processing or modification of the devices may occur before their use by patients or users. UDI numbers must be reported only on package labels,  not on the individual devices.

The new guidance limits the definition of convenience kits to exclude any devices that may be further processed once packaging is opened by the end user.

According to the guidance, first aid kits and anterior cruciate ligament (ACL) disposable kits are examples of convenience kits, whereas non-sterile orthopedic device trays and reusable devices packaged together are not included in the new definition.

Manufacturers may need to reassess their products, and adjust their UID compliance processes if necessary.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479242.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery