By Amy Fowler – RCRI
The Unique Device Identification System Final Rule was published on September 24, 2013. Now, September 24th is a compliance deadline date for years to come. Labels and packages of Class III devices and devices licensed under the Public Health Service Act must bear a UDI by September 24, 2014. Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI by September 2015. More UDI compliance deadlines come up on September 2016, 2018 and 2020!
But wait! Do these dates really apply to you? First, you need to find out if your organization is a labeler according to the final rule. The term ‘manufacturer’ just did not work for this rule. A labeler is any person (think corporation, not just you personally) who causes a label to be applied to a device with the intent that the device will be commercially distributed OR replaced or modified with the intent that the device will be commercially distributed. Simply adding the name of the person who distributes the device, without making other change is an exception.
So what devices does it apply to? ALL DEVICES! That is the general rule. Think of it as a big blanket that covers everything. Do not panic. There are some exceptions. These exceptions are like small cutouts from the big blanket. They are like a hole here and a little hole over there, but you have to figure out if any of them actually get you out of meeting the requirement. If you decide an exception applies, be sure to document that decision.
The rule has a lot of details, plus, other rules are being changed so that UDI becomes the future of referring to the right version and/or model. Do you know which issuing agency you will work with? Do you have your device identifiers figured out for all the labels and packages that need them?
You have some time. Just remember September 24th.
Amy Fowler, RAC, J.D.
Principal Advisor, Regulatory Affairs
Regulatory & Clinical Research Institute, Inc. (RCRI)
Direct: 952-224-2255 Main: 952-746-8080