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  • 1.  UDI HIBCC Easily Readable Plain-text Size

    This message was posted by a user wishing to remain anonymous
    Posted 24-Oct-2023 16:04
    This message was posted by a user wishing to remain anonymous

    Hello, 

    We are currently trying to decipher what the minimum or suggested font size for UDI HIBCC Easily Readable Plain-text Size would be. Currently our research has not resulted in anything definitive on what the minimum font size is for HIBCC standards. Any guidance is appreciated. 


    Thank you 



  • 2.  RE: UDI HIBCC Easily Readable Plain-text Size

    Posted 24-Oct-2023 18:27

    UDI requirements are generally harmonized across jurisdictions except for a few things here and there like Europe's unique (no pun intended) additional requirement for a Basic UDI-DI in addition to a UDI-DI(s).  Though there is a lot of harmonization, it would still be best if we knew the exact jurisdiction(s) that you are targeting.

    I'm unaware of any HIBCC standard (or any other UDI standard) that prescribes the font size for the human-readable aspect of a UDI.  For example, HIBCC's 2016 Supplier Labeling Standard simply requires a "legible font".  Similarly, FDA's UDI regulation requires the human-readable portion to be "easily readable".  That regulation goes on to refer us to ISO/IEC 646 for the character set, but which states that it does not specify a particular style or font design.  The IMDRF guidance points us back to the issuing agencies and their [lack of] specifications.

    So ultimately, I advise that the font size of the human-readable aspect of the UDI, like any other aspect of the labeling content, needs to be sufficient to accommodate the readers' human factors/usability needs.  This might be different depending on the nature and characteristics of the subject device and its intended use environment.  For example, devices intended for use in darkened environments or for reading from a distance or at oblique angles might need a more prominent human-readable UDI portion than a device used in well-lighted areas with reading straight on.  AAMI HE75 has a nice table correlating font size with reading distance and angle; consider leveraging those specifications for purposes of UDI design verification.  And for UDI design validation, if your usability studies confirm that the users find the human-readable portion of the UDI to be easily readable in their environments, then that is the best litmus test in my opinion.



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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: UDI HIBCC Easily Readable Plain-text Size

    Posted 25-Oct-2023 07:41

    In addition, we have used these additional US FDA-related resources for support:

    1.  A study in 2007 evaluated the effectiveness of the 1999 FDA mandated standardised format called Drug Facts for the labelling of over the counter medicines and compared three labelling formats, the old, new and simulated. They found that consumers preferred the label format with a larger font size over those currently available. In addition, it was noted that the new OTC drug labels may not be easy for some consumers to use and understand, although they are an improvement over old unstandardised labels. It was concluded that manufacturers should look beyond the mandatory minimum font size (FDA 6 point) and develop strategies to improve comprehension of information on OTC medication labels.  From: Murty S & Sansgiry S, Consumer comprehension of OTC Medication Labels and the scope for improvement in font size. J Pharm Technol, 2007; 23:207


    2.  How large must the Nutrition Facts label be?  Answer: There are no specific size requirements for the nutrition label. However, the "Nutrition Facts" heading must be in a type size larger than all other print size in the nutrition label and generally set the full width of the nutrition facts label (21 CFR 101.9(d)(2)). Minimum type sizes of 6 point and 8 point are required for the other information in the nutrition label (21 CFR 101.9(d)(1)(iii)), and there are minimum spacing requirements between lines of text (21 CFR 101.9(d)(1)(ii)(C)).

    To that end, we have recommended a minimum type sizes of 6 point for HRI.

    Thanks,

    Jay



    ------------------------------
    Jay Crowley
    Vice President, Medical Devices and UDI Practice Lead
    USDM Life Sciences
    jcrowley@usdm.com
    +1-805-880-2591
    Baltimore MD
    United States
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    Original Message


  • 4.  RE: UDI HIBCC Easily Readable Plain-text Size

    Posted 26-Oct-2023 06:47

    Hello Anon,

    In the regulations themselves, you will not find a specific requirement or guideline on minimum font size of the human readable portion.  There are tangential information which can be used to ensure this can be met if challenged, such as FDA's guidance on other items such as labelling, readability standards (various sources), or packaging/labelling white papers.  For readability there are many considerations to be made because a font size or even type of font may be appropriate in one situation/environment (like on a screen) compared not appropriate in another situation/environment (like on a single-use package label).



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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