Medical devices cover a wide range of products including implants, CT scanners, surgical instruments, contact lenses, and blood glucose tests plus others. Unlike drugs, many medical devices currently do not have a unique identifier to clearly distinguish one product from another.
FDA is in the process of establishing the Unique Device Identifier (UDI) to be used on labels, packaging, and on the product itself for certain devices. Device companies must submit certain information on these devices to a database known as the “Global Unique Device Identification Database or referred to as GUDID. This database has all the key device identification information submitted to FDA on medical devices that have UDIs.
FDA recently in partnership with NIH’s National Library of Medicine released a new open access data website known as Access GUDID http://accessgudid.nlm.nih.gov where anyone can search and down load information on UDIs submitted to GUDID with all the key device identification information included.
Each device entry in the system contains information on the device’s characteristics, approval status, whether it is subject to a recall, instructions for sterilization and handling, and the relevant FDA product code.
The device information available on Access GUDID is the most recent data submitted to FDA that has completed the grace period after initial publication. The grace period is the time when device companies may make significant edits to their information, however, once the grace period is completed, only limited editing of device information is possible.
As FDA states, “The implementation of UDI is not yet complete. The UDI rule is already in effect for most high-risk devices (Class III) but many other devices will not need to comply for several more years.”