The FDA’s UDI System is a Historic Point in Medical Safety

The first phase of the FDA’s unique identification (UDI) system began on September 24, 2014. This marks an historic point in medical safety. The purpose of the UDI is to give the labels of medical devices a unique number or code that enables the device to be easily identifiable by healthcare workers, patients and caregivers. Those responsible for labeling devices must also submit information about each device to the FDA’s Global Unique Device Identification Database (GUDID). This database is open to the public and enables anyone to search and download details about medical devices.


How Does UDI Benefit the Industry?

The final rules benefit the medical industry in a number of ways:

  • All device labels must use the international and the Global Medical Device Nomenclature (GMDN) coding system—this helps to streamline standards for global medical commerce.
  • Direct marking is only required for devices which are intended for reprocessing; implantable devices are exempt—this eliminates the need for extra verification for implantable devices.
  • Companies are permitted a 3-year grace period to label existing inventory—this gives the industry time to redirect devices that are not in compliance.
  • Single use devices are exempt if they are part of another package and will not be distributed individually—this eliminates the need for UDIs on every individual package.


Here at Innovatum our experts have been delivering world-class compliance software for more than two decades. We are dedicated to meeting the compliance challenges of highly regulated industries and we specialize in biotech pharmaceutical and medical device. We are proud of our leadership role in the AIM North America UDI Committee and our technology, including the GS1 certified label design and print engine. Contact us today to find out how we can help you address all your labeling challenges.