FDA finalises its unique med device identifiers guidance

The US regulator has delivered its final guidance on unique device identifiers (UDIs) for tracking medical devices through the supply chain, taking into account some but not all of the feedback it received from manufacturers.

The long-awaited guidance comes almost five years after the first draft was published, and more than seven years after the FDA issued its final rule on UDIs, designed to improve adverse event reporting, allow easier recall of devices, fight against counterfeiting, and improve patient safety.

Under the rule, FDA established a seven-year phase-in period for UDI compliance, depending on the medical device class and type. Implementation has been ponderous and subject to considerable delays, however, amid concerns that patient access to products might be impacted, and the deadline was pushed back in 2018.

The finalised guidance covers the form and content of the UDI, which must be presented in both plain-text and digital (automatic identification and data capture or AIDC) formats on the device label and packaging.

The guide lays out the FDA's thinking on the use of data delimiters – which indicate what each element of the code correspond to – as well as the order that data should be presented in the easily readable plain-text form.

It also includes a new section on UDI requirements for standalone software that isn't distributed in a packaged form, for example by download only.

In the latter case, there should be an easily readable plain-text statement displayed whenever the software is started or through a menu command, says the guide.

Another key change from the draft version was the elimination of a requirement to mark the UDI directly onto implantable devices, which was viewed as a big challenge at mass production scales.

The final version does not include a request by medical device manufacturers – represented by industry group AdvaMed – to remove the recommendations covering order of elements in the UDI carrier should be ordered, and to include data delimiters in the easily readable plain-text form.

AdvaMed had argued that including the data delimiters in plant text might be confusing for those who do not understand their purpose.

However, the FDA says it is "important for the easily-readable plain-text form of the UDI to include any data delimiter(s) [because] 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."