Medical Device Labeling Guidelines

Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff.

The FDA’s final rule has established a system for the unique identification of medical devices that is based on their use and means of distribution. As the system becomes fully implemented, device labels will carry a unique device identifier (UDI). Companies responsible for device labelling are also required to submit certain information pertaining to each device to the FDA’s Global Unique Device Identification Database (GUDID) so that the public can search for and download this information.

Medical Barcode

The Benefits of UDIs

The UDI system is being phased in over a number of years and has several benefits including:

  • improved patient safety
  • better post-market surveillance for medical devices
  • facilitated device innovation

Our expert team at Innovatum has been providing world-class standard compliance software for more than two decades. We are dedicated to meeting the compliance challenges of highly regulated industries such as the life sciences. We are proud of our leadership role in the AIM North America UDI Committee and our labeling technology, which includes a GS1 certified label design and print engine. Contact us today to find out how we can help you meet your medical device labeling needs.