On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension letter to device labelers, extending the UDI compliance date to September 24, 2018 for certain Class II devices. The devices impacted by the UDI compliance date extension are classified as:
- Convenience kits
- Repackaged single-use devices
The letter also clarified that the compliance date for biologic and drug device constituents is September 24, 2018. You can read more about the specific language in the extension letter here. In this blog, we’re going to focus on how this extension impacts your compliance process.
What the extension means
NiceLabel’s Vice President of Marketing, Ken Moir, raises this flag in connection with the recently announced date extension. “It’s important for labelers to keep in mind that the September 28, 2018 date could be changed at any time, so it’s important that they keep themselves apprised of the latest updates coming out of the FDA, and that they continue to work towards meeting the UDI compliance requirements, so that they’re in the best position to act, should the deadline date be moved up.”
The convenience kits
On January 4, 2016, the FDA published draft guidance on what would be considered a convenience kit for the purpose of UDI compliance and requirements submission (Read the “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug Administration Staff”). The draft document limits the definition of a convenience kit to kits “…that 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.” There has been a lot of discussion back and forth about how to apply this definition and this extension will give the Agency time to finalize the guidance regarding convenience kits.
“Here it’s important for labelers to understand that the current FDA definition is narrower than what they might be familiar with. So manufacturers need to be sure that their kits match the current working definition in order to be covered by the date extension,” comments Moir.
Repackaged, single-use devices
The second group of devices covered by the extension is repackaged, single-use devices. Again, to know if the extension applies to your devices, it’s important that your device fulfills the requirements set forth by the FDA in the UDI documentation. “Keep in mind that the date extension only applies to repackaged, single-use devices, not single-use devices alone,” Moir states. For the purposes of this extension, the FDA defines a repackager as someone who “packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).”
If your Class II devices don’t fall into the categories described above, your deadline for UDI compliance and GUDID submission is still September 24, 2016. Make sure you’re ready. Check out our Guide to UDI Compliance.