The U.S. Food and Drug Administration (FDA) published a final rule in the Federal Register on September 24, requiring that medical device labels and packages contain a unique device identifier (UDI). UDIs are numeric or alphanumeric codes that include a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number, and/or expiration date. UDIs will improve patient safety by “making it possible to rapidly and definitively identify a device,” resulting in improved accuracy in adverse event reporting, reduced medical errors caused by misidentification of a device, more efficient recalls, and more focused FDA-safety communications, according to the ruling.
UDI requirements will be phased in over the next seven years. Class III (“high risk”) devices will be the first phase, and must have a UDI by September 24, 2014. Devices finished and labeled prior to the compliance date for the particular device do not have to contain a UDI. This exception, however, expires three years after the compliance date for the particular device.
External limb orthotic and prosthetic components, limb orthoses, and truncal orthoses are generally classified as Class I medical devices, which is the lowest classification in terms of patient risk and the degree of regulatory control required. An external, assembled lower-limb prosthesis (890.3500) is listed as Class II on the FDA website and is subject to additional regulatory controls, as are cranial remolding helmets, the Innovative Neurotronics WalkAide®, and Bioness’ NESS L300® foot drop system and NESS H200® hand rehabilitation system.
The labeler of the item, usually the manufacturer, must also submit information about each device to a publically searchable database maintained by the FDA, known as the Global Unique Device Identification Database (GUDID). The FDA’s database will not contain personal privacy information.
