In September 2013, the US Food and Drug Administration released the final ruling on legislation requiring all medical devices distributed in the United States to carry a Unique Device Identifier (UDI) label. The regulation covers all products classified as medical devices, including Class I, II, and III, InVitro, software and tissue-based products.
The UDI law will be implemented over the course of a couple years, starting with Class III. All devices classified as Class III must be fully compliant by September 24, 2014. There are difference deadlines for different classifications of devices. Any company that is not compliant on the FDA time schedule, will be prohibited from selling or distributing their products in the United States.
What information is included in a UDI?
There are two elements that make up the UDI, the DI and the PI. A DI is a Device Identifier which is a fixed numeric or alphanumeric string that uniquely identifies the labeler and the specific version or model of a device. The PI or Production Identifier is a variable production control including the lot number, serial number, manufacturing date and/or expiration date.
All About the New Labels.
While many products are already barcoded, many of them may not be compliant with the new UDI regulation. A UDI is not a randomly self-generated code, or created by your company. It must be approved by the FDA and issued by one of the three companies that have received special FDA accreditation. The Device ID must also be registered in the FDA’s Global Unique Device Identifier Database before it may be used on a UDI label.
The FDA GUDID database requires approximately 60 fields of data to be provided for every Device Identifier, including device description, company information, packaging information, storage and handling conditions, sterilization information, ect.
This new UDI ruling requires all labels to be readable by bother humans as well as machines (usually in the form of a barcode). Due to the amount of information required by the FDA, new labels may need to be bigger than the existing ones, as using smaller fonts may not be readable by humans.
If the product intended for use may be separated from it’s packaging or pouch, it is required that both parts have a DUI label. For instance, if a product is shipped in a cardboard box with several individual pouches inside, the box must me properly labeled, as well as each pouch within the box.
New Label, New Printer
Most medical device manufacturers use thermal transfer printers to print their labels. If all the information required by the UDI is able to fit on your existing label, there is no need to update, but if the print is too small or there is information missing, a printer capable of printing on larger labels, may be necessary.