By Michelle Morgan, Quality Assurance and Regulatory Manager
The FDA has instituted a new requirement to mark each medical device or kit with a Unique Device Identifier number (UDI) that establishes a system to standardize and adequately identify medical devices through distribution, use and the supply chain. The unique device identifier is a unique set of alphanumeric codes consisting of both a Device Identifier (company and product code) and a Production Identifier (specific manufacturing information). This label is applied by the manufacturer or distributor prior to sale.
We are proud to advise you that we have implemented the required changes to our Quality Management System. In upcoming months, you will see a UDI, both in a data matrix barcode and a human readable format located on our device packaging.
The FDA released the final rule on UDI in 2013 and established compliance dates for implementation based on the class and type of the device. This rule applies to medical devices of all classes, any case configurations they may have, and trauma and first aid kits. Exceptions to this rule are outlined in 21 CFR 801.30.
It is intended to be used as a powerful tool for device identification. The manufacturer is required to upload device details into the FDA’s Access Global Unique Device Identification Database (GUDID) website. The distributor or end user can then input the barcode data which will link back to retrieve the information about the device.
Want to know more about UDI? Then follow this link to learn more about the requirements for UDI: http://fda.yorkcast.com/webcast/Play/455307461f76415ead204eeb03dedad61d
When you are ready to assemble a custom kit, H&H is ready to help you with the parts, packaging and labeling to meet FDA requirements.