The U.S. Food and Drug Administration (FDA) has established a unique device identifier system(UDI) to facilitate the identification of medical devices. UDI guidelines specify proper usage of the unique device identifier in both human- and machine-readable forms and are intended to enhance the safety of healthcare workers, patients and caregivers. Manufacturers of medical devices are required to enter each device’s information into the FDA’s Global Unique Device Identification Database (GUDID), which will enable the public to search, access 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 “higher level of 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 UDI labeling of Class III medical devices.
Medical device manufacturers are permitted a 3-year grace period to label existing inventory—this gives the industry time to manage 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 the information that we garner in our leadership role in the AIM North America UDI Committee with our specialized technologies, to deliver best in class UDI solutions. Contact us today to find out how we can help you address all of your life sciences labeling needs.
