FDA has released draft guidance on the use of symbols on labels for IVDs sold in the United States. In an effort to conserve space and increase clarity, FDA has officially recognized 25 symbols for use on IVD labels. As an alternative to providing product labeling in multiple languages, the European Union's IVD Directive encourages the use of symbols from harmonized standards to convey required information in the place of text. To facilitate the trade of IVDs in the international marketplace, the United States has followed suit.
The approved symbols have been adopted from the medical device symbols presented in two harmonized standards developed through international consensus: ISO 15223, Medical Devices—Symbols to Be Used with Medical Device Labels, Labeling, and Information to Be Supplied, and EN 980, Graphical Symbols for Use in the Labeling of Medical Devices. Carolyn D. Jones, JD, associate vice president, technology and regulatory affairs, at AdvaMed (Washington, DC) and a member of the IVD Technology editorial advisory board said, "What we're trying to do by presenting FDA with symbols that have been developed through a standards process is to provide the users with some consistency."
FDA acknowledges that symbology would play an important role in labeling for IVDs that would be sold both in the United States and abroad. The language requirements of the IVD Directive would place a heavy burden on the label real estate available on IVDs. Initially, manufacturers met these requirements with the use of tighter and smaller typefaces, which threatened to diminish the legibility of the text.
FDA acknowledges this potential problem in the guidance by stating, "Because symbols take up less space than the text for which they may substitute, the use of symbols promotes less crowded and more-legible IVDs."
In addition to the dangers posed by overcrowding on the labels, the agency noted that the logistics of creating multiple labels in several languages for one product might present complications. The guidance points out that "An additional advantage [of using symbols in place of text] is that there are likely to be fewer labeling errors when using a single label, rather than having one set of labels for use in the United States and another set for use in the European Union." Judging by the language used in the guidance, FDA seems to wholeheartedly support the use of symbols for IVDs, but this was not always the case.
Up until this point, FDA had been reluctant to accept the use of harmonized symbols on IVDs without an accompanying explanation of each symbol in English. The use of both symbols and their descriptive subtext would place greater restrictions on label real estate. The agency was worried that, without their accompanying subtext, the symbols would not be understood by end-users.
Many industry groups, including AdvaMed, were adamant about the importance of the use of symbols on IVD labels. Jones notes, "in the future as products are marketed to an increasingly global marketplace and you go up to 12, 13, even 18 languages—it would not be reasonable for manufacturers to have to label that way. We think using symbols is a way to use the space that we have on the labels appropriately, and yet relay the related information clearly."
The agency used focus groups consisting of professional end-users to test the symbols for their ease of recognition. These studies generated promising results. According to Jones, members of focus groups presented with the imagery reported that "they thought the use of symbols might actually cut down on some of the errors they have in the lab, and they felt quite comfortable with them."
Although FDA seems to be comfortable enough with the findings generated in the focus groups to have approved the use of the symbols without explanatory subtext, the agency has taken precautions. In an effort to present the symbols to only those who are familiar with them, the guidance recommends the use of symbols only for IVDs designed for use by trained professionals. The symbols are not to be used for over-the-counter or home-use IVDs.
In addition, FDA recommends that manufacturers include a glossary of terms defining each symbol in an insert accompanying each product. FDA also calls for an educational outreach effort to be made by IVD manufacturers and that they extend this effort to all parties involved in the IVD distribution chain. Some suggestions for disseminating information on symbology are the use of wall charts, the posting of information on industry Web sites, and the provision of training sessions.
The guidance can be accessed via the Internet at www.fda.gov/cdrh/ocd/guidance/4444.html [5].
ILLUSTRATION BY MARCO AGUILERA
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