UDI Label Case Study

A long-term medical device customer needed to transition the labeling on products to new UDI labels that met specific FDA requirements. The deadline for the transition was quickly approaching so they reached out to JN White® to help them develop and execute the transition to the new labels in a timeline manner. JN White® investigated the requirements, tested current labels and determined what alterations needed to be made to meet the requirements. In addition, the team at JN White® managed the entire transition and made certain new labels were in place by the deadline.

Challenge

A major U.S. medical manufacturer and long-time customer contacted JN White® with a timely request for their Class II medical device labeling. The criteria included labels that could:

  • Withstand temperature, humidity, chemical testing, and CaviWipe™ cleaning
  • Color match existing housing
  • Be aesthetically appealing
  • Following the FDA label requirements

Additionally, the customer needed barcode grade reports so that they could substantiate adherence to the new policy in the event of an audit. Finally, the project needed to be completed expeditiously as the deadline was quickly approaching.

How JN White® Helped

The team at JN White® quickly began evaluating the labels the customer had been using in the past to determine if the current labels would meet UDI requirements as long as the laser-readable barcode could be added. Ultimately, all tested adhesives passed temperature and humidity tests however, the ethanol removed clear varnish and digital ink. The team discovered that top-surface variable printing of contrasting colors with protective over laminate resulted in both the highest barcode functionality as well as surpassed barcode grade requirements. In addition, JN White® invested in specific equipment to enable the printing and testing of these types of labels.

The Result

As a result of this project, JN White® was able to quickly and painlessly transition the customer from their existing labels to labels that met all the FDA requirements for UDI labels on medical devices. The team became experts on the requirements and guided the customer through the process. The final result was the implementation of Class II UDI medical device labeling across all products produced at JN White®. Because of the quick response by JN White® to this request, the transition was accomplished within the timeframes required for compliance.

Ken Boss JN White

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JN White is an ISO 9001:2015 and ITAR-certified manufacturer of membrane switches, graphic overlays, and custom labels. All of our products are Made In The U.S.A. We specialize in the design and manufacture of complex graphic overlays, complex membrane switch keyboards, assembly and membrane switch testing. Our supporting products and services include: rapid prototyping; electronic shielding (ESD); backlighting (including addressable LEDs); design & development; vendor managed inventory (VMI); and medical device, UDI and UL label constructions. JN White works with global brands in the aerospace, medical device, medical instruments, industrial electronics, consumer appliance and defense (or military/DoD) industries. Made in America. Made in the U.S.