FDA finalizes long-awaited UDI guidance

The US Food and Drug Administration (FDA) on Tuesday finalized its guidance on the form and content requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule.
 
FDA said the guidance is intended to describe “the requirements for, and FDA’s recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule,” and is aimed at labelers and FDA-accredited issuing agencies. (RELATED: UDI form and content: FDA offers draft guidance, Regulatory Focus 25 July 2016)
 
The guidance itself provides a description of the two forms of a UDI, which include the easily readable plain-text form and the automatic identification and data capture (AIDC) technology form, and discusses the use of data delimiters and the order that data should be presented in the easily readable plain-text form of the UDI carrier.
 
Final Guidance
 
The final guidance includes clarifications on the agency’s expectations for the forms and content of UDI throughout. The guidance also now includes a figure providing an example of a UDI in both easily readable plain-text and AIDC forms, along with other non-UDI label information.
 
While the final guidance has been revised from the draft version in response to comments, FDA has rebuffed industry’s requests for several changes to the document, including as they relate to data delimiters and FDA’s recommendations on the order of data represented in the easily readable plain-text form.
 
FDA explains that the guidance does not apply to universal product codes (UPC) but explains that, “UPC may serve as the UDI to meet the requirements of 21 CFR 801.20 (21 CFR 801.40(d)). However, “a Class I device labeler may choose to use a UDI rather than or in addition to a UPC.” FDA notes that labelers maintain proper controls over UPC assignment and use “to advance the goals of the UDI system.”
 
FDA has also revised the section of the guidance on data delimiters, which are defined data character(s) that identify specific data elements within an encoded string and are used to identify the information that immediately follows them.
 
“Data delimiters are key to UDI comprehensibility and utility. A data delimiter indicates and distinguishes each data element within the data string represented in the UDI carrier, and inclusion of data delimiters is important for both the easily readable plain-text and AIDC forms of the UDI,” FDA writes.
 
FDA further explains that “data delimiters allow the UDI to be distinguished and captured separately from any non-UDI elements that may be represented in the UDI carrier. In addition, if non-UDI elements are included in the UDI carrier, separate data delimiters for these non-UDI elements should be included. Without appropriate data delimiters to identify non-UDI elements, individuals may not be able to use the easily readable plain-text form of the UDI to identify a device and computer systems may not be able to capture accurately the UDI in AIDC form via an automated process.”
 
In comments submitted to the draft guidance, medical device industry group AdvaMed pushed back on FDA’s recommendations related to data delimiters. “We do not agree that data delimiters are a component of a device’s UDI that must be included in the easily readable plain-text form. FDA’s rules specifically define a UDI to be composed of a device identifier (“DI”) and product identifier (“PI”) … Data delimiters are not mentioned in the Agency’s rules, nor are they even contemplated in the Preamble to the Federal Register Notice announcing the rule,” AdvaMed wrote.
 
AdvaMed had also called for FDA to remove the section of the draft guidance that provided recommendations for how the elements UDI carrier should be ordered, pointing out that the UDI Final Rule “does not prescribe an order for UDI and non-UDI elements in the UDI carrier.”
 
FDA opted to keep its recommendations on the order of the data represented in the UDI carrier largely unchanged. As in the draft version, FDA explains that the UDI should precede any non-UDI elements in the UDI carrier and that the DI should be ordered before the PI. After the PI, if any, non-UDI elements such as expiration date or quantity. FDA adds that, “Quantity is not considered part of the UDI and the data delimiter for quantity should be different than the DI and PI data delimiters in the UDI.”
 
Lastly, the final guidance includes a new section providing recommendations for labeling requirements for stand-alone software. FDA advises that for stand-alone software that is not distributed in packaged form, UDI labeling requirements are met if the UDI is provided through an easily readable plain-text statement displayed whenever the software is started and/or an easily readable plain-text statement displayed through a menu command. In such cases, the PI must also convey the stand-alone software’s version number.
 
FDA