Over 80,000 medical device products already registered in new US FDA database
95% of devices registered in FDA UDI GUDID database carry a GS1 GTIN as the Primary Product Identifier
Since the introduction of the US FDA UDI regulation in September 2014, medical device manufacturers have had to register all Class III devices being sold in the US market in the FDA's Global UDI Database or GUDID. The next compliance date is 24th September 2015 for Class II implants and life-supporting/life-sustaining devices. UDIs will be phased in over several years, starting with the highest risk devices, such as heart valves and pacemakers.
The purpose of the Global Unique Device Identification Database (GUDID - pronounced "Good ID") database is to store key device identification information submitted to the FDA. The information will be used to identify a medical device in a consistent and standard way throughout its distribution and can subsequently be used by healthcare providers & patients. The National Library of Medicine (NLM), in collaboration with the FDA, has created the AccessGUDID portal to make device identification information in the GUDID available for everyone, including patients, caregivers, health care providers, hospitals, and industry.
Medical devices cover a wide range of products - implants, CT scanners, surgical instruments, contact lenses, wheelchairs, and blood glucose tests, to name a few. To date, over 80,000 devices have been registered in the GUDID portal and over 77,000 of the devices carry a GS1 GTIN as the primary product identifier.
If you have any questions about the implementation of UDI identification codes, barcode labelling or data uploads please contact one of our expert advisors.