The Food and Drug Administration (FDA) has set specific standards for the labeling of medical devices. It is vital that medical devices are labeled clearly and concisely to ensure that healthcare providers, patients and caregivers are able to understand the labels and use the devices in a safe and appropriate manner.
What is Unique Device Identification (UDI)?
The UDI system is designed to assign a unique number or identifier to U.S. medical devices. It has been in process since September, 2007 as part of the Food and Drug Administration Amendments Act of 2007. The system requires:
- Medical device labels to bear a unique identifying number or code
- The UDI must enable the identification of the device through distribution and use
- The UDI must include an FDA specified lot or serial number
The UDI system facilitates a shared vocabulary for use with electronic tracking and analysis of adverse event reports. Its implementation is intended to improve patient safety by helping healthcare staff to distinguish between similar medical devices, by helping with the identification of counterfeit medical products, and by improving the recall process.
ROBAR Device Labeling
Medical device labeling doesn’t have to be a chore. Here at Innovatum, we can provide you with the ROBAR Labeling. Our innovative system facilitates central management of the entire label lifecycle from design to production and beyond. It integrates seamlessly with PLM, ERP and similar systems.
Our executive management team at Innovatum has almost 80 years combined experience delivering compliance software and services in regulated industries. Call us today and let our experts tell you how we can help you with your medical device labeling.
