Regulatory Focus™ > News Articles > How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains

How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains

Posted 15 January 2016 | By Zachary Brennan 

How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains

The US Food and Drug Administration (FDA) is looking to shed more light on cases where two or more medical devices packaged together, in what the agency calls a “convenience kit,” would need to comply with unique device identifier (UDI) labeling requirements.

According to the draft guidance, the term convenience kit, which the guidance attempts to adjust, “applies solely to two or more different medical devices packaged together for the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 not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.”

The individual devices in such kits are exempt from UDI labeling requirement as long as the UDI is included on the label of the immediate container of the kit.

FDA’s new position, which it says constitutes “a change in policy,” makes clear that since the publication of the UDI Rule, the agency has decided that the term “convenience kit” does not include implantable devices and instruments that are “provided by the labeler in sets or trays as non-sterile and repeatedly reconfigured and sterilized (or cleaned and sterilized) prior to use.”

The agency explains its change of heart by noting that the overarching objective of the UDI Rule is to provide a system that can adequately track and identify medical devices through distribution and use, particularly around adverse events.

Examples

A first aid kit containing bandages, cold compresses, scissors and an oral thermometer is considered a convenience kit for the purposes of UDI compliance.

However, a non-sterile orthopedic device tray or set, which, at the time of writing the UDI rule was considered to be a kit, is now not considered to be a convenience kit and all of its component devices do need to have a UDI because the “devices are not intended to remain packaged together; rather, they are intended to be removed from their packaging before being placed in trays for a surgical procedure and sterilized prior to use, with the trays regularly reassembled and 185 restocked for subsequent surgical procedures.”

But an anterior cruciate ligament (ACL) disposable kit comprised of sterile, single-use instruments such as guide wires, drill tip guide pins, tunnel plugs, and graft passer that are used for ACL reconstruction procedures and are packaged and sealed in a single container is considered a convenience kit for the purposes of UDI compliance.

And finally, FDA offers the example of reusable medical devices packaged together, which it says would not be a convenience kit.

Draft Guidance for Industry Unique Device Identification Convenience Kits


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe