The FDA has released a draft guidance: Unique Device Identifier Convenience Kit.  This document further explains the phrase “convenience kit” and how it applies to the UDI rule.  The FDA released their final rule for UDI on September 24, 2013, requiring most medical devices to label a UDI.  The UDI will have many benefits such as improved product information and faster product identification for problems or recalls.  Labelers have been complying with the label and data submission requirements, ensuring that each device has its own UDI.  For convenience kits, each individual device does not have to have a UDI as long as the main container of the kit bears a UDI.  Previously, a convenience kit included implantable devices in sets or trays that would be repeatedly used and sterilized.  The FDA has determined that this previous use of convenience kit did not fulfill the UDI rule.  The FDA currently defines “convenience kit” at 21 CFR 801.3 142 as “applying solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and the individual devices within the package not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.”  Read the full FDA documents for all of the information on the UDI Final Rule or Convenience Kits.