In today’s healthcare landscape, ensuring the safety of patients and maintaining an efficient supply chain is critical for medical device manufacturers. The Unique Device Identifier (UDI) system is a key component in achieving this.
This article will guide you through UDI labeling regulations, breaking down the essentials for compliance, for a deeper dive into the specifics of medical device, pharmaceuticals, and healthcare labeling requirements and best practices.
What is UDI labeling?
The UDI system final rule, established by the FDA, requires medical device labelers—typically, the manufacturer—to include a UDI on device labels and packages and submit device information to the Global Unique Device Identification Database (GUDID). This helps identify medical devices sold in the U.S. from manufacturing through distribution to patient use.
A UDI has two parts:
Device Identifier (DI): The DI is a fixed portion of the UDI that identifies the labeler and the specific version or model of a device. It doesn’t change and serves as the backbone of the device’s identification system.
Production Identifier (PI): The PI is a variable portion that may include one or more of the following:
Lot or batch number of the device
Serial number of the device
Expiration date of the device
Date the device was manufactured
Distinct identification code for tissue-based products
These pieces of information help track the device’s production and lifespan, making it easier to manage and recall devices when necessary.
How do I comply with UDI labeling requirements?
To comply with UDI labeling regulations, manufacturers must meet specific requirements in how the UDI is displayed on their devices and packaging. Here are the key requirements:
Human-readable and machine-readable formats
All UDIs must be displayed on labels and packages in both human-readable (plain text) and machine-readable formats. The machine-readable portion is typically encoded using automatic identification and data capture (AIDC) technology, such as barcodes or Radio Frequency Identification (RFID).
Standardized date formats
Any date on a device label, such as the expiration or manufacturing date, must follow a standardized format: YYYY-MM-DD. This ensures consistency and clarity across the global medical device market.
Where do I get started with UDI labeling?
Compliance with UDI regulations can seem daunting, but by following a clear process, manufacturers can ensure they meet FDA requirements.
Step 1: Obtain a UDI from an FDA-accredited issuing agency
The first step in creating UDI labels is contacting an FDA-accredited issuing agency. The FDA has approved three issuing agencies to operate a system for assigning UDIs:
- GS1
- Health Industry Business Communications Council (HIBCC)
- International Council for Commonality in Blood Banking Automation (ICCBBA)
- Labelers must contact one of the issuing agencies directly to use their system for issuing UDIs for their devices.
Step 2: Submit device information to GUDID
After obtaining the UDI, manufacturers must submit device information to GUDID. This database is publicly accessible and serves as a reference for healthcare professionals, regulators, and patients to identify medical devices.
GUDID only includes the DI part of the UDI, which is used to look up information about the device in the database. While GUDID doesn’t store PIs, it has flags to show which PI details are part of the UDI.
Step 3: Evaluate your current labeling processes
Make sure your labeling software can support both human- and machine-readable formats. It should also handle various barcode types, such as GS1-128 or GS1 DataMatrix, and offer the flexibility to generate unique serial numbers or batch numbers for PIs. Your printer must also be capable of producing high-quality labels with readable barcodes to meet UDI standards.
Now that you understand the basics of UDI labeling, here’s a quick checklist to ensure compliance:
- Obtain a UDI from an FDA-accredited issuing agency.
- Submit the DI portion of the UDI to the GUDID.
- Update your labeling software to support UDI data and format requirements.
- Ensure your printers can handle the new labels.
- Train your team on the requirements to ensure proper labeling.
By following these steps, you can ensure your medical devices meet all UDI labeling requirements, keeping your products compliant and patients safe.
