FDA finalizes long-awaited UDI guidelines

Posted on July 06, 2021 | Through Michel mezher

The United States Food and Drug Administration (FDA) finalized its guidelines on form and content requirements for unique device identifiers (UDI) on Tuesday, nearly five years after the publication of its draft guidelines and eight years after the publication of the final UDI rule.

The FDA said the guidelines are intended to describe “the FDA’s requirements and recommendations regarding the form and content of UDI to help ensure that UDIs developed as part of UDI delivery systems meet the requirements of the UDI. objectives of the final rule of the unique device identification system. And is intended for labellers and FDA accredited issuing agencies. (RELATED: Form and content of UDI: FDA proposes draft guidelines, Regulatory guidance July 25, 2016)

The guide itself provides a description of the two forms of a UDI, which include the easily readable clear text form and the automatic identification and data capture (AIDC) technology form, and discusses the use data delimiters and the order in which the data should be presented in the form of easily readable clear text from UDI support.

Final guidelines

The final guidance includes clarifications on the agency’s expectations for UDI forms and content throughout. The guide now also includes a figure providing an example of UDI as plain text and easily readable AIDC, along with other non-UDI tag information.

Although the final guidelines have been revised from the draft in response to comments, the FDA has rejected industry requests for several changes to the document, including regarding data delimiters and FDA recommendations. on the order of the data represented in the easily readable clear text form of text.

The FDA explains that the guidelines do not apply to universal product codes (UPC), but explains that “UPC can serve as a 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”. The FDA notes that labellers maintain appropriate controls over the allocation of UPC and use it “to advance the goals of the UDI system.”

The FDA also revised the section of the guidelines on data delimiters, which are defined data characters that identify specific data elements in an encoded string and are used to identify information that immediately follows them.

“Data delimiters are essential to the understanding and usefulness of UDI. A data delimiter indicates and distinguishes each data item in the data string represented in the UDI medium, and the inclusion of data delimiters is important for both easily readable plain text and AIDC forms of UDI The FDA writes.

The FDA further explains that “Data delimiters allow UDI to be distinguished and captured separately from any non-UDI elements that may be represented in the UDI medium. Additionally, if non-UDI elements are included in the UDI carrier, separate data delimiters for those non-UDI elements must be included. Without proper data delimiters to identify non-UDI items, individuals may not be able to use the easily readable clear text form of UDI to identify a device, and computer systems may not be able to capture accurately UDI form AIDC via an automated system. treat. “

In comments submitted to the draft guidelines, medical device industry group AdvaMed rejected FDA recommendations regarding data delimiters. “We don’t agree that data delimiters are a component of a device’s UDI that should be included as easily readable plain text. The FDA rules specifically define that a UDI is made up of a device identifier (“DI”) and a product identifier (“PI”)… Data delimiters are not mentioned in the rules. Agency, nor even envisaged in the preamble of the Federal Register Notice announcing the rule, ”wrote AdvaMed.

AdvaMed had also asked the FDA to remove the section of the draft guidance that provided recommendations on how carrier UDI items should be ordered, stressing that the UDI final rule “does not mandate an order for UDI items and not -UDI in the carrier UDI. “

The FDA has chosen to keep its recommendations on the order of the data represented in the UDI medium largely unchanged. As in the draft, the FDA explains that UDI must precede any non-UDI item in UDI support and that DI must be ordered before PI. After the PI, if applicable, non-UDI elements such as expiration date or quantity. The FDA adds that “the quantity is not considered to be part of the UDI and the data delimiter for the quantity must be different from the DI and PI data delimiters in the UDI.”

Finally, the final guide includes a new section providing recommendations for labeling requirements for stand-alone software. The FDA recommends that for stand-alone software that is not distributed as a package, UDI labeling requirements be met if the UDI is provided via an easily readable clear text statement displayed each time the software is started and / or an easily readable clear text statement displayed via a menu command. In such cases, the PI must also transmit the version number of the stand-alone software.


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