On January 14, 2015, the U.S. Food and Drug Administration (FDA) hosted two webinars to assist Class II and implantable, life-supporting and life-sustaining device labelers, as well as new Class III device labelers with Unique Device Identifier (UDI) and Global Unique Device Identification Database (GUDID) requirements. Class III device labelers are currently required to comply with these requirements, while the compliance date for implantable, life-supporting and life-sustaining device labelers is September 24, 2015 and the compliance date for Class II device labelers is September 24, 2016.
Registrar Corp listened in on both webinars. Today we’re publishing a rundown of the first webinar, “UDI 101.” Tomorrow we’ll summarize the second webinar.
UDI 101 was put on by Loretta E. Chi, the Regulatory Policy Analyst in FDA’s CDHR Office of Surveillance and Biometrics. Much of the webinar covered the basics of the UDI system. Chi did, however, go into detail about packaging.
The UDI is required to be placed on a device’s label and packaging. FDA defines a device package as packaging containing a fixed quantity of a particular version or model of a device. There are different levels of packaging. The lowest level is “base packaging,” the packaging immediately surrounding an individual device. The next level of packaging would contain a fixed number of devices packaged in their base packaging.
For example, one syringe could be packaged in a small box, which would be its base packaging. Perhaps these packaged syringes are sold in a bigger box that holds six of these individually packaged syringes, which would be its next level of packaging. An even higher level of packaging could be reached if a large box contained four of bigger boxes that contain six syringes.
Each level of packaging requires a different UDI. Keep in mind that even the same “level” of packaging can be offered in different versions. Using the example above, along with the 2nd level package that contains six individual syringes, there could be a 2nd level package that contains twenty individual syringes. These two packages would also require different UDIs.
During the webinar, one listener asked if he could place the UDI on the bottom of his device’s packaging. Chi said that FDA has not specified where the UDI must be placed on the package, so at this point in time it may be placed anywhere. She noted that the purpose of the UDI system is to have information visible and available to consumers, so the bottom of a package may not be the best placement.
Another question was asked regarding the direct placement of a UDI on a device. When a UDI is placed directly onto a device it is called direct marking. Direct marking is only required for reusable devices. Chi said only the UDI is required to be placed permanently on the device, not the device’s entire label. She also clarified that the UDI is required to be in either human-readable or machine-readable form, not both, when directly marked on the device.
During the question and answer session, Chi said that the DI and PI portions of a UDI may be divided into separate barcodes. She also said that accessories sold for medical devices require their own separate UDI.
Registrar Corp can assist medical device establishments with FDA’s UDI requirements. We can help to determine the requirements for a specific device and can assist with submitting data to GUDID. For assistance or to ask questions regarding UDI or GUDID requirements, contact Registrar Corp at +1-757-224-0177 or through the 24-hour Live Help chat service.
Check back tomorrow to read about FDA’s second seminar, “Getting Ready for GUDID.”