On September 24, 2013, the Food and Drug Administration (FDA) issued a Final Rule regarding a new way companies must label and classify devices called the unique device identifier (UDI) system. The new rule requires each device’s label and package to include a UDI unless an exception applies. The Final Rule is accompanied by a draft guidance further explaining the new system’s database entitled the “Global Unique Device Identification Database (GUDID),” where UDI information will be submitted and maintained, allowing information about the device to be accessed.
The Food and Drug Administration Amendments Act (FDAAA) of 2007 and the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 added a new section to the Federal Food, Drug, and Cosmetic Act, which requires FDA to establish a UDI system for devices and an implementation timeframe for certain devices. The agency released the Proposed Rule on the UDI system on July 12, 2012, and subsequently published an amendment modifying the implementation timeframe on November 19, 2012. The Final Rule is motivated by an effort to provide for more rapid identification of devices with adverse events and development of solutions to reported problems, increase the accuracy of adverse events reporting, and reduce medical errors resulting from misidentification of devices or confusion about their uses.
Must I Comply with the UDI System Final Rule?
Every device’s label and package must bear a UDI, unless an exception or alternative applies. The following devices’ label and packages are not required to bear a UDI:
- Devices or device accessories suitable for use labeled prior to the compliance dates as explained later in this article;
- Class I devices that bear a Universal Product Code (UPC) or that FDA has exempted from good manufacturing practice (GMP) requirements, except for certain recordkeeping requirements;
- Individual, single-use devices distributed together in a package and that are intended to be stored in the package until removed for use and which are not intended for individual commercial distribution, as long as the package bears the UDI;
- Devices packaged within the immediate container of a combination product or a convenience kit (i.e., two different devices packaged together for the user’s convenience), as long as the convenience kit bears a UDI or the combination product bears a UDI or National Drug Code (NDC) number;
- Devices used “solely for research, teaching or chemical analysis, and not intended for any clinical use;”
- Custom devices;
- Investigational devices;
- Veterinary devices;
- Devices intended to be exported from the United States;
- Devices held by the Strategic National stockpile and granted an exception or alternative;
- Devices for which FDA has established or recognized certain performance standards and provided an exception; and
- Combinations products that bear an NDC number and its constituent devices if the components are combined or mixed and produced;
Other exceptions or alternatives may apply if FDA initiates and grants an exception or alternative if it is “in the best interest of the public health;” or, the labeler submits a written request and FDA determines “an exception is appropriate because the [UDI labeling requirement is] . . . not technologically feasible, or that an alternative would provide for more accurate, precise, or rapid device identification” than the UDI labeling requirement, “or would better ensure the safety or effectiveness of the device that would be subject to the alternative.” Nevertheless, even if a device is not required to bear a UDI, a firm may label the device with a UDI.
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