UDI is here: Seven Things You Need to Know
Now that US medical device regulators have begun implementing their Unique Device Identification (UDI) system, many device manufacturers are questioning how best to comply with the new requirements in the most efficient manner possible. At Emergo, we’ve identified seven key (and common) issues firms should consider as they undertake their UDI compliance projects.
- Does my device require the “direct marking” of the UDI number? This depends on the type of device, as all medical devices intended to be used more than once or intended to be reprocessed before each use must have direct marking of the UDI. The FDA has stated as part of the regulation that implantable devices will not require the direct marking. Single-use devices do not require direct marking of the UDI number on the device.
- What packaging level do I need to place the UDI on the labels? The UDI must be on each level of packaging up to shipping, which does not require the UDI number to be on the shipping box or pallet. The important thing to remember is that the UDI must be available to the user at all points of use. As an example, a carton of ten units sitting on a shelf must have the UDI number, and the individual unit from that carton being used at the patient bedside must have the UDI number.
- Where do I actually get this UDI number? There are three Issuing Agencies (IA) currently accredited by the FDA that assign the Device Identifier portion of the UDI. The Device Identifier (DI) is composed of a unique company identification and a unique number assigned to each version or model of device. If a company has ten different models or versions of a device, then they would have 10 distinct DI numbers. The UDI may then be composed of the DI and the Production Identifier (PI) that includes information such as lot number, serial number, or expiration date. The FDA does not actually assign the UDI since this number is obtained from the IA and then entered into the FDA’s Global Unique Device Identification Database (GUDID).
- How do I get an account with the FDA for the GUDID database? Currently the FDA is only assigning GUDID accounts after these are requested through an email request from the FDA. That is, a firm must request a GUDID account on the FDA website; the FDA then sends the applicant a form to fill out. Once the applicant sends back the form to the FDA via email, the agency reviews the form, and then sends an email back to the applicant with GUDID account log-in information. In other words, it’s not like other sites where one can just “register” to set up an account. The FDA is limiting the amount of accounts being assigned currently in order to manage and build the GUDID system. Only Class III, life-sustaining, and life-supporting devices are being provided GUDID accounts. No Class II or Class I devices are able to obtain a GUDID account at this time. However, this does not preclude that companies can already obtain their DI number through the Issuing Agency and start placing the UDI on their packages; they just would not be able to enter the information in the FDA GUDID database yet.
- Do we need to change the date format on our labeling? The FDA has specified in the regulations that the date format of YYYY-MM-DD must be used for all dating on product labeling such as expiration dates or date of manufacture. If an organization is currently using the MM-DD-YYYY or MM-YYYY format for their expiration dating, then this would need to be changed to stay compliant with the regulations.
- There are many types of bar codes that exist; which one am I required to use? The FDA has made it clear that Automatic Identification and Data Capture (AIDC) such as bar codes are “technology neutral,” meaning that whichever method a Labeler/Manufacturer chooses, there is technology that can be used. An organization must determine which bar code or other AIDC technology is most appropriate for their device and their customer needs. As an example, a Class III device with a long UDI number and a small package may need to consider a 2-D Matrix style bar code in order to fit on the label. Or a Class II device with a large label being sold in small doctors’ offices with limited bar code reader capability could choose to use a GS1-128 style linear bar code on the package label.
- I have my UDI, is that all or are the other things that I need to do? As with any regulatory compliance, there always seems to be an endless chore of activities that need to be performed. The quality management system must be updated to include all of the requirements associated with UDI number management. This includes when packaging or labeling is changed that the Change Order process must have an assessment or impact evaluation to continue compliance with the regulations. The customer complaint and adverse event procedures must ensure that they are capturing the UDI information. An overall procedure or process should be documented for how the UDI numbers are managed, including steps for obtaining the number, adding new versions or models, and discontinuing versions or models. It is advisable that the UDI process is integrated into the entire quality management system as it can touch on many areas such as labeling, supplier management, Device History Records, customer complaints, and recall activities.
UDI implementation is a complex and time-consuming endeavor for US medical device market registrants. Emergo has additional resources explaining US UDI requirements, including a whitepaper on UDI available for download as well as blog coverage of US UDI compliance requirements and exceptions.