Although the UDI rule will not become mandatory until 2013, this is a good time to start thinking about what changes you need to make to your labeling and data processes. Advanced planning and readiness now can better prepare you for action when the mandate is activated.
Winco ID is going to be exhibiting at Electronics North East/BIOMEDevice Tradeshow where we hope to see you. You’ll have the opportunity to talk one-on-one about the new FDA rule on Unique Device Identification (UDI) and how to set your plan for successful compliance.
While the details of the UDI rule are not yet complete, there are some basics that are known:
- The label of the device includes a unique identifier mark in a machine readable form (aka the bar code.)
- The unique identifier mark must be durable enough to be able to accurately identify the device through its expected life-cycle and use.
- The unique identifier will include the lot or serial number of the device and other information specified by FDA.
In addition to the labeling, it is going to be necessary to upload data to the UDI database that will be used for tracking and traceability of the device through the lifecycle of the device.
So why talk to us about this?
One reason is that Winco ID has more than 20 years experience in providing durable label solutions – many of which are already used in the medical device industry.
Winco ID can help ensure you are 100% in compliance with all aspects of the labeling mandate, right down to the finest detail. This includes the label material and print quality for durability, the validation of the bar coded information and handling of the related data.
Also, the UDI program being proposed by the FDA is very similar to the Unique Identification mandate that the Department of Defense introduced a few years ago. Winco ID has worked with hundreds of clients to ensure successful labeling, data management and how to mainstream this process for effective operations.
Don’t wait until you are faced with penalties for non-compliance, or dis-satisfied customers due to label failure or missed shipments. Talk to us at the show or call 603.598.1553 to see how we can help you.
Want more information on the BIOMEDevice Tradeshow? How are you tracking the progress of the FDA mandates? Do you know if you will need to comply? Share your thoughts with us and others below.