FDA has finalized guidance on the form and content of unique device identifiers used to track medtech products through the supply chain.
The final text responds to, but in some cases holds firm against, concerns raised by groups including AdvaMed about the 2016 draft, such as changes to the wording about the inclusion of data delimiters in the easily readable plain-text form of the UDI.
FDA has also added a new section to the final guidance. The section covers UDI requirements for standalone software that is not distributed in packaged form.
The guidance is intended to ensure UDIs meet the objectives set out in FDA's final rule on the topic. The aim is to improve reporting of adverse events so that problem devices can be identified and corrected faster. With a standardized identifier, device manufacturers and healthcare facilities should be able to better manage recalls.
FDA published the final rule in 2013, at which time it aimed to have completed the phased rollout of the requirements by 2020. FDA pushed back the target in 2018 in response to "complex policy and technical issues" before granting a further delay to Class I and unclassified products last year.
Amid that series of events, FDA posted draft guidance on the form and content of UDIs for feedback. Five years later, FDA has finalized the guidance. The reworked version features changes to some of the sections that received pushback from industry.
AdvaMed, for example, disagreed with FDA's proposal that data delimiters must be included in the easily readable plain-text form of the UDI. The trade group said data delimiters—data characters that identify specific data elements within an encoded data string represented in the UDI carrier—may confuse individuals who review the UDI as they do not understand their purpose and meaning.
The draft said "the easily readable plain-text form of the UDI should include the device identifier (DI), production identifiers (PIs), and data delimiters contained in the UDI." FDA has deleted that line from the final guidance but reiterated its case for the inclusion of data delimiters in the plain-text form.
"It is also important for the easily-readable plain-text form of the UDI to include any data delimiter(s) for the DI and PI. If the data delimiters are not included, an individual may not be able to use the easily readable plain-text form of the UDI to identify the device," the final guidance states.
Other changes include the addition of a section on standalone software. The guidance differentiates between software that is and is not distributed in packaged form. If software is not distributed in packaged form, companies can comply with the UDI requirement by displaying an easily readable plain-text statement when the software is started or upon the use of a menu command.
Packaged software must provide a plain-text statement on startup or command, too, but in that case the device label and package must also carry a UDI in plain-text and automatic identification and data capture forms.