The FDA has issued a final rule requiring that medical device labels and packages contain a unique device identifier (“UDI”). Devices intended to be used more than once and reprocessed before each use generally must also contain the UDI on the device itself. The FDA states that the UDI 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.
The UDI is composed of two parts: (1) a device identifier and (2) a production identifier. The device identifier identifies the specific version or model and labeler of the device. The labeler of a device is the person who causes the label to be placed on the device, or who causes the label to be replaced or modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. The labeler is generally, but not always, the manufacturer. The production identifier more specifically identifies the device with information such as lot or batch number, serial number, expiration date, or date of manufacture. All dates on device labels must be listed in a standard year-month-day format for purposes of consistency. In addition, UDIs must be presented in both easily readable plain-text and automatic identification and data capture technology (e.g., barcodes), and will be issued by an FDA-accredited agency.
Further, the labeler of a device must submit information regarding each device to a publically searchable database maintained by the FDA, known as the Global Unique Device Identification Database (“GUDID”). Users of a medical device will be able to search the GUDID for information regarding the particular device, using the UDI. The GUDID will not include patient information, such as which individuals use a particular medical device.
The UDI will be phased in over the next seven years, with the FDA requiring compliance in order from high-risk medical devices to lower-risk devices. The first phase of compliance is for Class III devices, which must bear a UDI by September 24, 2014. Class I medical devices exempt from the FDA’s good manufacturing practice requirements are exempt from the UDI requirement. Further, 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.