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Date Format Quandary for FDA UDI for Medical Devices

In my last blog I wrote that the FDA proposed a rule that requires a unique device identifier (UDI)  to be placed on the label and packaging of a marketed and sold medical device. It turned out that internally at StarFish, the required date format caught the attention of our engineers more than any other requirement.

The manufacturing date format that is part of the new rule provoked an interesting discussion among our engineers. In general, our engineers liked the idea of the full date format for manufacturing, but there were questions as to why the ISO 8601 standard was not used for the date format (i.e. 2012/07/02) instead of the proposed format (i.e. Jul 02, 2012).

I have to say that personally, I like the proposed format. Growing up in Europe, we used a different date format that included Roman numerals (2 VII 2012).  When I moved to Canada and became employed by a company with 7 locations and 13 departments, it drove me nuts trying to figure out all the personal preferences for all the various date formats for each department. In 2001, the date format got more complicated – I am sure that we have all encountered dates recorded as 12/07/01 or 01/07/12 or 07/01/12 – the ultimate auditor’s nightmare.  As a head of Quality Assurance, I saw the need to harmonize date formats and make it obvious what the effective or approval dates were – so we implemented the new company rule – date format in MMM, DD, YYYY. Initially, there were some objections, but shortly after the implementation, everyone appreciated the clarity of the system.

So, my only explanation in defence of the FDA’s proposed format is that we need to think about end users who may not be familiar with the standard and that having letters for the month and 4 digits for the year removes any ambiguity about expiration dates. If Jul 02, 2012 was written as 2012/07/02 or 2012/02/07 medical workers and patients alike may interpret the date as either February or July. Using the device after its expiry date may have serious consequences.

Interestingly enough, the FDA presentation on the subject has examples of labels that do not follow the proposed date format (MMM, DD, YYYY). However, the FDA website has an example of a label with the proposed format.

[Editor’s note:  The FDA issued this Update on UDI Implementation for Registered Medical Device Establishments on December  18, 2014.]


2 responses to “Date Format Quandary for FDA UDI for Medical Devices”

  1. Matt Chroust says:

    Unfortunately, any date presentation involving three-letter English abbreviations for months is going to create confusion for non-English speaking end users who may not be familiar with the language.

    ISO requirements give member states the authority to require that English on medical device labeling be translated, which turns this date code into a tower of Babel. Rather than try to re-invent the wheel and impose English abbreviations on the rest of the world, FDA should accept presentations in either ISO 8601 OR its own “preferred” English format.

    Generally, it’s a idea to base regulations on personal preferences. That’s a human factors/usability pitfall.



  2. Johannes says:

    We recommended our engineers to follow 21CFR801.18…

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