The UDI label is the endgame.
We’ll guide you there.
The FDA launched the Unique Device Identification (UDI) Rule in September 2013. The mandate was designed to provide identification and traceability for medical devices, from production through distribution and end-of-life.
Click here for the schedule of compliance dates.
A UDI label must include specific data in both human and machine readable formats.
Device Identifier (DI)—Identifies the labeler and the device model or version
Production Identifier (PI)—Provides production information:
- Lot or batch number
- Serial number
- Expiration date
- Date of manufacture
Understand the specific UDI requirements for your device(s).
Create a Global Unique Device Identifier Database (GUDID) account and an FDA listing number.
Gather and validate your GUDID data.
Incorporate the 62 data attributes into your label.
Adhere to the GUDID submission process.
Know which parts need to be directly marked with a UDI (versus affixed with a label).
Follow the approved format for the UDI label.
Deploy a UDI compliance labeling solution that includes software, hardware, and label media.
You can leverage the knowledge, experience, and diligence of a dedicated UDI Compliance Team. Qualitas will expertly handle your compliance tasks, start to finish. We know how to navigate the process, saving you the time and frustration of a potentially tangled learning curve. Avoid the costly delays that can occur with data and submission mistakes.
Qualitas is a Global Medical Device Nomenclature (GMDN) Agency. We can create the 5-digit numbers required for UDI. We ensure that your product is accurately categorized—because a mistake here can lead to a big problem. As a GMDN Agency, we can also monitor changes and alert you if anything impacts your products.
We are also committed to industry standards with memberships in key industry groups:
- Association for Advancement of Medical Instrumentation (AAMI)
- Regulatory Affairs Processional Society (RAPS)
- International Organization for Standardization (ISO)
Eliminate the guesswork
UDI compliance isn’t just about a label. That’s the culmination of many steps, with each one potentially sending you back to the beginning if you make a mistake.
Contact Qualitas to ensure complete compliance.