The U.S. Food and Drug Administration (FDA) has adopted a final rule establishing a unique device identification system (UDI) that will “provide a consistent way to identify medical devices.” According to FDA, the UDI system “builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development.”
It consists of two components: a unique number assigned by the device manufacturer to the version or model of the device, including productionspecific information “such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label”; and a publicly searchable database—the Global Unique Device Identification Database—that FDA will administer to serve as “a reference catalogue for every device with an identifier.” The database will not store any identifying patient information.
Within one year, high-risk medical devices (Class III), in general, “will be required to carry unique device identifiers on their label and packaging . . . and corresponding device information must be submitted to the new database.” Most manufacturers of moderate risk (Class II) devices will have three years to comply, and Class I device manufacturers “not exempt from UDI requirements will have five years to act.” The agency has also issued draft industry guidance that explains how to submit information to the new database. Comments on the draft are requested by November 25, 2013. See FDA News Release, September 20, 2013; Federal Register, September 24, 2013.