UDI Label Requirements & FDA Regulations
Overview of UDIs
A Unique Device Identification (UDI) system provides universal identification of medical devices at every stage from production to use in patient care. UDI utilizes both plain to read text and machine identifiable markers conveyed within Automatic Identification and Data Capture systems for ease of tracking. This system is made possible by the Global Unique Device Identification Database (GUDID), which provides a global standard to prevent misidentification and misuse of medical devices. Most devices have a UDI-DI (Device Identifier) that is linked to a more specific jurisdiction-based UDI database.
The FDA established the UDI system of identification to properly address the issue of medical device misidentification and track devices in the United States. With a UDI system in place that follows FDA guidelines, the human and machine-readable identifier improves patient safety and adds an extra way to identify mistakes and correct them before issues arise.
FDA Regulations for UDI Device Labels
The UDI Rule requires a UDI to be included on both device labels and packaging unless the rule provides an exception or alternative. For example, if a device is meant for multiple uses and is meant for reprocessing before each use, the UDI must be displayed directly on the device to ensure proper identification.
Device information must be submitted to GUDID and must be displayed in two forms: machine-readable form that uses automatic identification and data capture (AIDC) and plain text that is easily readable. AIDC is technology that is capable of reading and conveying the UDI in a digital form for use in databases. When the UDI is intended for use with AIDC, the dates must be presented using the international standard format (YYYY-MM-DD).
DoraniX’s UDI Printers and Equipment
DoraniX is proud to offer the latest in medical package printing solutions. With our customized ThermaPrint 64 series, we are able to print highly customizable variable data directly onto medical grade Tyvek, medical pouches, and surgical lids. These printers are capable of labeling packages at rapid rates, with many fonts, customizable features, and a high-definition print head of 305 DPI (Dots Per Inch).
Our UDI printing capabilities also include the use of Cognex DM262X barcode graders, which ensure readability and log and store every scanned label if necessary. Our Webscan Omni barcode verifier evaluates every label for quality and ensures defect-free prints. At customer request, we can use Webscan and Cognex optical inspection technology to inspect samples and create a barcode validation report.
DoraniX for your UDI Printing Needs
The FDA emphasizes the importance of medical package labeling. DoraniX has an exceptional reputation for providing quality products that yield quality results. If your medical devices need FDA compliant labeling, our friendly representatives are here to discuss your needs and find the right solution for you. For more information on our products and services, contact us today.