The FDA’s new ruling on Unique Identification or UDI is very clear when it comes to the deadlines. Depending on what you manufacture or need to label/mark with a UDI, you may be facing a deadline that is less than one year away. Others will follow in sequence according to published dates.
UDI compliance can be quite an involved process and touch many areas of a medical device manufacturing business. Simply stated, manufacturers must obtain a UDI for each medical device, label or mark each unit, packaging, or both, and submit data to the GUDID (Global Unique Identification Database.)
Depending on how many items are required to be marked, how many changes this item undergoes, and how large your manufacturing operation is, can exponentially increase the complexity of UDI compliance.
It may require more planning for those who are not familiar with barcoding or the necessary equipment needed. That is yet another step as each UDI label or mark must contain an Auto ID mark (barcode) in addition to the text to allow for automatic data capture.
To help you understand the complexities of UDI compliance, particularly in the labeling and marking of the medical device and packaging, ID Technology has prepared an eBook titled “Guide to Labeling and Marking Compliance for UDI.”
This eBook is an easy-to-read guide to walk you through the UDI compliance process. It provides a basic understanding the labeling and marking requirements for UDI and simplifies what medical device manufacturers need to do to comply with the FDA’s UDI ruling.