As you prepare for another Unique Device Identification deadline in September, be aware that FDA has released new draft guidance to assist in ensuring labeling accuracy. The guidance is short (ten pages) and outlines basic and important material regarding what is included in the unique device identifier (UDI).
The guidance covers the two manners in which the UDI must be present on the label and device packages: 1) easily readable plain-text, and 2) automatic identification and data capture (AIDC) technology. The AIDC is meant to be read by a bar scanner, while the plain-text format may be used in the event that the AIDC cannot be scanned or used.
The guidance serves as reminder that a UDI comprises:
1. A Device Identifier (DI), which is defined as, “A mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device.”
2. For Class II and III devices, one or more Production Identifiers (PI), which may be a device’s:
a. Lot or batch number
b. Serial number
c. Expiration date
d. Date of manufacture
e. Distinct identification code (for an HCT/P regulated as a device)
3. Data delimiters, meaning a defined character or set of characters that identifies specific data elements within an encoded data string. The data delimiter indicates the DI or PI value as well as non-UDI elements, and varies based on the FDA-accredited issuing agency that you use.
Your UDI should be labeled with the DI, followed by the PI.
Of course, the UDI carrier might contain non-UDI information. FDA’s guidance clarifies that non-UDI elements must follow the UDI elements.
“For example, if the label of a particular device bears the expiration date PI and quantity, and the labeler wishes to include the quantity in the UDI carrier, the easily readable plain text of the UDI carrier should display the data delimiter for the DI, followed by the DI; the data delimiter for expiration date, followed by the expiration date PI; and lastly, the data delimiter for quantity, followed by the quantity.”
UDI is a massive undertaking. One can presume that the latest draft guidance was issued due to a lack of clarity on how to create a UDI. After reading the guidance, companies will presumably have more questions for FDA and their UDI issuing agency.
At OMTEC 2016, FDA representatives spoke on the importance of accurately capturing UDI data due to its continual use by government, by hospitals, by the public and others. During the presentation, FDA made clear that companies are challenged in compiling this information.
The DI is the key, said Leslie Steen, Ph.D., Lead for Standards and Vocabularies on the (UDI) Program Staff. Not only must it be formed correctly, but also entered correctly into the Global UDI Database (GUDID).
About 80% of the data entered in GUDID is linked to orthopaedic companies, according to FDA. For further information on UDI compliance, view the OMTEC presentation slides as well as previous BONEZONE coverage.