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 in boosting increasing safety. 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 proposal required manufacturers to mark the UDI directly onto the following types of implantable 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 of Class I single-use devices 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.s

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.


What is Unique Device Identification?

The U.S. Food and Drug Administration (FDA) have established a unique device identifier (UDI) to facilitate the identification of medical devices. The unique system is in both human- and machine-readable forms and is intended to enhance the safety of healthcare workers, patients and caregiver. Manufacturers of medical devices are also required to enter each device’s information into the FDA’s Global Unique Device Identification Database (GUDID), which will enable the public to access, search and download information about specific devices.

Benefits of Unique Device Identification

The UDI system has a number of benefits for medical device manufacturers including:

  • Making devices safer
  • Improving patient outcomes
  • Improving post-market surveillance
  • Improving adverse event reporting

The FDA finalized the system on September 20, 2013. The FDA is currently phasing in the UDI system by focusing on Class III medical devices. Class III medical devices are those which are considered to require the most rigorous monitoring because they present a “high risk” when it comes to patient safety. Examples of Class III medical devices include:

  • heart valves
  • pacemakers
  • silicon-based breast implants
  • cerebellar stimulators

The FDA requires labeling of all Class III medical devices.

Medical device manufacturers are permitted a 3-year grace period to label existing inventory—this gives the industry time to redirect devices that are not yet in compliance with the regulations of the FDA’s final rule.

Here at Innovatum we have more than 20 years’ experience with providing world-class compliance software within the Life Science fields including pharmaceuticals, biotech, medical devices as well as many other highly regulated industries. We combine our leadership role in the AIM North America UDI Committee which our specialized technologies, including the GS1 certified label design and print engine. Contact us today to find out how we can help you address all your labeling needs.





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