Today, the U.S. Food and Drug Administration (FDA), in partnership with the National Institutes of Health National Library of Medicine (NLM), is making data on devices with unique device identifiers (UDI) publicly available for the first time through a website called AccessGUDID (http://accessgudid.nlm.nih.
In 2013, the FDA released a final rule to establish a UDI system designed to adequately identify medical devices through distribution and use. Device labelers (often, the manufacturer) must include a UDI on device labels and packages, except where an exception or alternative exists, and submit device identification information about these devices to the FDA’s Global Unique Device Identification Database (GUDID).
Because the UDI system is being phased in over the next several years, labelers are currently submitting data on only the highest risk medical devices, a small subset of marketed devices. But as the system is implemented according to the compliance timeline, the records of all medical devices required to have a UDI will be included.
Through AccessGUDID, anyone can search or download information that labelers have submitted about their medical devices to the GUDID. Device identification and key safety information, such as whether the device is safe for use while undergoing MRI, will be available for health care providers to search at any time.
As we launch this beta version of AccessGUDID, we encourage everyone —health care systems, clinicians, patients, researchers and industry— to explore its contents, assess its functionality, and provide us with feedback. This feedback will shape future enhancements, including advanced search and web services.
For more information about UDI, GUDID, and AccessGUDID, or to view UDI training modules, visit the FDA’s UDI webpage.