UDI Series: Lessons Learned for Meeting UDI Compliance

This is the first of an ongoing series to help medical device manufacturers and labelers better understand the Unique Device Identification (UDI) regulation.

In this first article, we highlight what QA Consulting has learned through our experience implementing UDI for start-ups, midsize, and global medical device manufacturers.

What is UDI?

The Unique Device Identification system, established by the FDA, identifies medical devices through their distribution and use.  UDI applies to all classes of medical devices distributed in the United States.  Compliance deadlines are staged over a span of six years, from September 24, 2014 to September 24, 2020

Since the release of the UDI regulation in September 2013, medical device manufacturers and labelers have been diligently working to meet the remaining compliance deadlines. The UDI regulation incorporates several significant changes to current medical device labeling practices, including:

• The incorporation of a UDI on device labels and packages
• For select devices, incorporating a permanent UDI on the device itself
• Standardizing the date format for device labels
• Requiring submission of over 60 data attributes to the Global Unique Device Identification Database (GUDID).

We learned several important lessons in the process:

1. 1. 1. 1. 1.  Create a Quality Plan. The first step in meeting UDI compliance is to understand and plan for which requirements and deadlines apply to your products.
            2. Update Necessary Quality Management System (QMS) Documentation. Many companies have generated a UDI-specific procedure, in addition to making UDI related updates to existing procedures surrounding labeling, complaints, corrections and removals, and adverse event reporting.
            3. Choose the Right Issuing Agency. An FDA-accredited issuing agency, including GS1, HIBCC, and ICCBBA, must be selected to issue UDIs.  Each agency has its pros and cons related to cost, device type, and healthcare provider capabilities.  Most companies have chosen GS1, and we encourage manufacturers to follow suit as the GS1 UDI format is becoming the industry standard.
            4. Understand the Packaging Levels and Configurations for each Device. Assigning the correct number of UDIs can be tricky. Remember that each device, each level of packaging (with the exception of the shipping container), and each packaging configuration should have a unique UDI.
            5. Validate UDI Barcode Readability. Standards such as ISO 15415, ISO 15416, and AIM DPM-1-2006 can be used to grade the quality of the UDI barcodes.
            6. Plan for GUDID Outages and Maintenance. The FDA’s GUDID does occasionally go offline for outages or maintenance.  The GUDID system status can be checked here and you can also sign up for GUDID status email notifications.

As a medical device manufacturer or labeler now armed with these insights, we hope you are one step closer to meeting UDI compliance.  If you need assistance implementing UDI, please call 512-328-9404 or contact us at info info@qaconsultinginc.com.