FDA UDI Compliance
The FDA’s Unique Device Identifier (UDI) system was designed to track medical devices through the entire distribution and use cycle.
While the UDI deadlines for Class 2 and 3 medical devices have come and gone, Class 1 medical device manufacturers face a September 24, 2020 compliance date. UDI requires that device labels and device packages bear a UDI and that key data for these devices be submitted to the FDA’s GUDID.
Use UDI compliance as an opportunity to digitally transform labeling
- Consolidate labeling systems and processes
Maintaining multiple labeling systems is expensive, not to mention time consuming. Disparate systems can produce label variations and inaccuracies. Standardize on a single platform for labeling that integrates with core business systems to streamline the entire labeling process.
- Empower business users
Having business users create label templates using a simple, Microsoft Word-like user interface means that costly IT resources can focus on other mission critical projects.
- Eliminate errors and mitigate risk
Label errors are costly mistakes considering they are one of the main causes of medical device recalls. Digitizing your labeling eliminates the need for error-prone, manual processes and establishes a secure and controlled label design and approval process.
- Streamline your supply chain
Establish consistent labeling processes across all manufacturing sites to transform the supply chain and eliminate the need for costly, separate labeling operations at each location.
What is a UDI?
A UDI is a unique numeric or alphanumeric code displayed in both human readable (plain text) and machine readable (AIDC) form that consists of two parts: a device identifier (DI) and production identifier(s) (PI).
The Device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device.
The production identifier (PI) includes lot or batch number, serial number, expiration date, and date of manufacture.