The US Food and Drug Administration (FDA) has announced a new regulation that would allow medical device products to use a stand-alone symbol or image on the product's labeling under specific circumstances, saying that its use could benefit consumers by making the product's use and limitations more clear.
Healthcare product labeling is tightly regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act), which governs everything from the information that must be on the label to the information's layout, the font used, the language used and the size of the font.
The end goal with all products is to make sure consumers and healthcare providers are able to understand the identity, benefits and risks of a product, enabling them to use it more safely and effectively.
Critically, federal law also requires that all information contained in the product labeling be truthful and accurate, without the possibility of a consumer being misled (defined as "likely to be read and understood by the ordinary individual under customary conditions of purchase and use" and bearing "adequate directions for use").
But not all important information is necessarily text-based. A traffic "Stop" sign, for example, conveys its information in part through text, but also through a standardized symbol, a red octagon. For regulators, bringing this same concept to labeling stands to benefit healthcare consumers and providers in a similar way, allowing them to more easily and clearly access and identify important information.
FDA's authority to do so is grounded in the FDA Modernization Act (FDAMA), FDA said. Under the Act, FDA is allowed to "recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization," which can then be used as a requirement or voluntary component of submissions.
The use of such standards, including for the adoption of symbols in labeling, isn't new. FDA has long been permitted to allow prescription drug labels to contain a symbol indicating it is "Rx Only." However, this provision is not yet applicable to devices, though FDA has practiced enforcement discretion in this regard.
Now FDA wants to explicitly allow such statements in devices and biological products by revising 21 CFR 660, 801 and 809, allowing for several types of "Stand-alone" symbols, expanding greatly the potential universe of standardized symbols available to manufacturers.
Under the proposal, manufacturers could use any symbol adopted by a select group of recognized standards development organizations (SDOs) so long as those symbols are accompanied by a "symbols glossary" that explains what the symbol means. Now-recognized SDOs include the International Standards Organization (ISO), the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI).
Sought for by Industry
FDA noted that this change was requested by members of the medical device industry, which had argued that the use of symbols would make the labeling more user-friendly. The change could be especially beneficial for reading-impaired individuals, as the size of the labeling text can be difficult for some people to effectively read.
Industry had also called attention to the harmonization aspects of the proposal, FDA said, noting that other foreign regulators, and the EU in particular, permit the use of symbols.
"Under our proposed rule revising parts 660, 801, and 809, FDA seeks to harmonize US regulatory requirements with those of the European Commission by allowing stand-alone standardized symbols recognized by FDA to be used in medical device labeling when a symbols glossary contemporaneously accompanies the medical device," FDA explained.
In vitro diagnostic devices will be subject to a slightly different regulatory requirement, which would still allow for the use of certain symbols, but without explanatory text next to the symbol.
The number of symbols allowed could one day be considerable, FDA said.
"On its own initiative and in response to requests received from the public, FDA expects to assess standardized symbols from time to time as part of its consensus standards recognition process. FDA will consider recognizing symbols contained in standards developed by SDOs that follow a process where the standard development is transparent (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope."
Those symbols would be limited-conceivably-only by their ability to be validated through SDO procedures. That would exclude proprietary symbols from being used, but few others.
The rule is set to come into effect in 90 days.