As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device Identification (UDI), one of the first major decisions they needed to make: choose a device identifier (DI) issuing agency.
The final rule requires device labelers to include a UDI, a unique numeric or alphanumeric code, on device labels and packages. This includes two parts, a device identifier that identifies the labeler and the version of the device, and a production identifier which identifies aspects of the individual device, such as production date, “use by” date and batch number.
The DI must be issued by an officially accredited agency. Three agencies have been approved by the FDA to issue DIs in accordance with the final rule. Each agency offers different benefits that device labelers will want to weigh when choosing the standard for their DIs.
The issuing agencies are:
GS1 – A not-for-profit standards agency, GS1 sets international standards for supply chains, electronic data exchange, healthcare, and more. GS1 numeric codes licenses must be renewed at set periods. The pharmaceutical supply chain historically has utilized GS1 codes, but the agency has also been gaining momentum in the medical device sector.
HIBCC – Health Industry Business Communications Council is a nonprofit organization that has focused on setting standards for the healthcare industry. HIBCC codes are alphanumeric and are acquired after paying a one-time fee. Historically, the healthcare industry supply chain has utilized HIBCC codes.
ICCBBA – A non-governmental organization, ICCBBA focuses exclusively on standards for medical products of human origin, such as blood products, tissues, and organs for transplant. It manages the ISBT 128 standard used in more than 75 countries. The FDA has approved the organization to issue codes for blood bags and human cells, tissues, and cell/tissue-based products. ICCBBA codes historically have been used by blood banks, tissue banks, and organ transplant banks.
4 Questions to Ask Before Choosing an Agency
Medical device labelers will want to evaluate all three options before choosing a DI issuing agency. Some questions to consider include:
- Do you already use existing codes from one of these agencies? If you do, utilizing the same agency for your UDI labeling needs might make sense.
- Are you feeling pressure from downstream customers to choose a particular agency? If most of your business goes to customers who already use one set of standards, they may request that you use the same standards to better coordinate with their processes.
- Are your products sold internationally? If so, you may want to investigate whether the primary markets in which you do business require or strongly encourage a particular agency’s code.
- How many DIs will you need? Cost may be a factor when deciding whether to license or to purchase a code outright.
For experienced guidance concerning UDI requirements for US FDA and other global regulators, contact [email protected]