The article provides additional details regarding the medical device patient labeling. In particular, it describes the requirements regarding the appearance of text and graphics.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device patient labeling – a special type of labeling intended to communicate important information regarding the product directly to its users: patients and care partners. The authority additionally emphasizes the specific nature of patient labeling – since it is addressed to laypersons, all the information contained therein should be provided in such a clear and understandable way so that the person without any background in healthcare or special knowledge will be able to interpret it correctly and consider when using the device.
It is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the aspects related to the way the text and graphics should appear on medical device patient labeling.
Appearance of Text
First of all, the document outlines the key points to be considered to improve the speed of text recognition. For this purpose, the following measures could be taken:
- Splitting text into sections. The long text could be split into sections separated with headings capturing the key points, while the text itself can contain bullet points outlining the main aspects requiring attention. The headings could be in bold and uppercase to improve visibility.
- The type size and font used should be determined depending on the target audience and their needs. However, the authority encourages to use of at least a 12-point type size in case it is feasible, while in the case of labeling addressed to elderly people the type size used should be larger to ensure comfortable reading. The letters used should be easy to recognize (serif font to be used). The authority also mentions that the black type on a white background should be used to ensure the best contrast.
- The FDA also recommends avoiding the use of glossy paper as it often causes a glare. Moreover, the paper should be heavy enough to ensure good visibility of the letters.
- The most important words or phrases could be highlighted to warn the attention of a potential user. At the same time, it is important to be cautious with highlighting, as extensive highlighting will reduce the overall visibility of the text. The approach to highlighting should be consistent throughout the text to avoid confusion.
- To visually separate the sections of the text, visual blocks could be used.
- The information should be presented in a structured way with the tables used when necessary, as they help to communicate complex information simply and understandably. For the tables, the authority also mentions the following: in instruction manuals, tables are normally not appropriate and their use should be minimized; if a table is necessary to simplify complex information, it should be included in the instructions for use, while each table should be clearly labeled. It is also allowed to use lists, especially when describing the steps to be taken, or aspects to be checked. If the order does not matter, bullet lists could be used, otherwise, the points should be numbered properly.
Appearance of Graphics
The document also describes the approach to be applied for graphics and their appearance when used in medical device patient labeling. As explained by the FDA, such elements attract the attention of a person reading the labeling, and it is also easier to remember such elements than plain text. Sometimes it is also easier to communicate complex information by using graphics instead of text description. At the same time, to ensure graphics are used most efficiently, the following principles are to be considered by the manufacturer. First of all, graphics should:
- Attract attention;
- Re-emphasize the text of the medical device patient labeling;
- Be simple and drawn, without clutter, unneeded background, or extraneous detail;
- Demonstrate one concept, single idea, or point of information at a time;
- Be placed next to the corresponding text;
- Use cues such as circles or arrows to point out key information;
- Be clearly labeled;
- Be easy to understand;
- Improve understanding of essential information;
- Be recognizable to the audience; and
- Fit the target audience.
The authority further explains that both text and graphics contained in the labeling should be considered together in their combination to ensure the important information is duly communicated to patients.
The authority also outlines certain specific aspects to be considered, namely:
- When comparing two different illustrations, show the difference, if the difference is not distinct, the reader may get confused;
- Represent only simple concepts in your graphics, either of actions or the device and its surroundings;
- Confine action graphics to a single action whenever possible;
- Use a separate graphic for each distinct idea.
The FDA mentions that each time graphics are used, they should be properly labeled, and the appropriate references should be provided in a text when necessary.
The visual elements used in medical device patient labeling should be large enough to make it easy and comfortable for a reader to see the important details. Each illustration should be accompanied by comments describing the specific aspects it is dedicated to. The same as the text, graphic elements should be contrasted enough to ensure clear visibility. In this respect, the authority also mentions that photos sometimes have poor contrast, so the drawings and illustrations are preferable.
In summary, the present FDA guidance outlines the key points to be considered by medical device manufacturers for texts and graphics medical device labeling contains. The document describes the approach to be applied when including such elements in labeling to ensure it will be interpreted accurately.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.