Understanding the FDA UDI Final Rule

The U.S. Food and Drug Administration (FDA) released the final rule on a Unique Device Identifier (UDI) system on September 20, 2013. The system, along with the Global Unique Device Identification Database (GUDID) was 10 years in the making and is a vital step toward increasing the safety of medical devices. One of the most significant changes is the elimination of the requirement that all implantable medical devices—such as pacemakers and heart valves—have the UDI printed on the device itself. Originally the proposed rule required manufacturers to mark the UDI directly onto the following types of  devices:

  • Implantable devices that remain in the body for longer than 30 days
  • Implantable devices that are intended for more than one use
  • Stand-alone software

The final rule requires that the UDI be marked directly only on devices which fall into the latter two categories.lab work

Another significant change in the final rule is the extension of the UDI exemption for Class I single-use devices which now applies to single use devices in all categories, except for implantable devices, so long as the device’s packaging is marked with a UDI.

The final rule also changes the date format for medical device labels. Formerly the proposal recommended the American-centric date format. The final rule requires labels to bear the International Organization for Standardization format.

Contact Innovatum today to find out how we can help you with you labeling challenges. Our team of experts is dedicated to meeting the compliance challenges of highly regulated industries and we specialize in the fields of biotech, pharmaceuticals and medical devices. We understand the demands of the FDA final rule and we here to utilize our leadership role in AIM North America UDI Committee and our GS1 certified label design and print technology to help you meet FDA requirements.