FDA clarifies UDI rules for convenience kits

by Scott Vigneault, on January 26, 2016

Screen_Shot_2016-01-26_at_11.12.12_AMWe're in the midsts of the U.S. Food and Drug Administration's rollout of the Unique Device Identification (UDI) system. Beginning in September 2014 and continuing through 2020, medical device manufacturers will be required to add UDI labels to their products. At the outset, only pacemakers and heart valves were affected by the FDA's rules, but last September any implantable life-sustaining device was added into the fold.

As it continues to implement and develop these rules, the FDA is also working on minor changes and clarifications to make things easier for manufacturers. One recent example involves instances where two or more devices are packaged together.

Known as "convenience kits," these are defined by the FDA as devices that "remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified" before they are used. They do not include implantable devices, or devices that are packed as non-sterile and then repeatedly sterilized.

The question that arose among manufacturers was whether the individual devices in these packages will have to be labeled. The FDA holds that this will not be required, which will likely make things easier for manufacturers that are looking to simplify their operations. The FDA's example of a convenience kit is a standard first aid kit — the container itself may require a label, but the individual bandages do not.

In the next few years, it is likely that the FDA will continue to clarify its UDI compliance rules until they are fully implemented. For medical device manufacturers, this will require a degree of flexibility. An Enterprise Labeling Solution will help them meet compliance mandates while controlling costs.

For more information on UDI label software check out our webinar - addressing challenges for UDI.

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Topics:Regulatory

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