The U.S. Food and Drug Administration (“FDA”) wants to give manufacturers of medical devices in vitro diagnostics (“IVDs”) and biological products the authority to use certain symbols and images on their product labeling to convey safety information and instructions for use. A proposed rule published April 19 would revise the agency’s regulations at 21 CFR parts 660, 801 and 809 to allow the use in labeling of FDA-recognized, stand-alone standardized symbols, so long as a symbols glossary accompanies the product.
The FDA’s regulations on product labeling are designed to ensure consumers and health care providers have enough information to safely and effectively use the products. In the past, the FDA has allowed manufacturers to use symbols on package labels and within instructions for use to convey that information, but the symbols required explanatory, adjacent text. The FDA’s approach has differed from that of other regulators that allow the use of stand-alone symbols, resulting in confusion and greater costs of doing business for product manufacturers. Thus, the FDA’s proposal is intended to harmonize U.S. requirements with those of other regulators, particularly those of the European Commission. It is also intended to foster better communications to consumers using medical products in their homes or other settings outside of hospitals.
Although the proposed rule will allow the continued use of symbols with explanatory, adjacent text, it will also for the first time allow the use of certain symbols without additional text. Manufacturers may now choose to use any symbol adopted by a group of recognized standards development organizations (“SDOs”), so long as those symbols are accompanied by a glossary that explains the symbols’ meaning. Currently recognized SDOs include the American National Standards Institute, the International Standards Organization, the Association for the Advancement of Medical Instrumentation and the International Electrotechnical Commission. The FDA expects to assess standardized symbols as part of its consensus standards recognition process and will maintain a website with up-to-date information on recognized symbols.
The FDA does not intend to recognize proprietary symbols developed by manufacturers for their own use.
Prescription Devices, IVDs and Biological Products
The Food Drug and Cosmetic Act authorizes manufacturers of prescription drug products to label their products with the symbol statement “Rx only” without accompanying explanatory text. However, this option has not been formally available to prescription devices, even though the FDA has exercised enforcement discretion with respect to allowing use of the symbol since 2000. In this new rule, the FDA proposes to codify device manufacturers’ ability to use the symbol statement “Rx only” or “℞ only” without accompanying explanatory text.
Similarly, the FDA has allowed the use of certain recognized symbols in IVD labeling without explanatory text, even though no regulation or law explicitly authorizes the use of symbols in the labeling of IVDs. Under the newly proposed rule, the ability of IVD manufacturers to use symbols in labeling without explanatory text would also be formally authorized.
Finally, the proposal also applies to the labeling of biological products that are also medical devices. It amends the specific labeling requirements applicable to biological products to allow for the labeling use of standardized symbols accompanied by a symbols glossary. It also changes 21 CFR part 660 labeling regulations applicable to certain biologic diagnostic substances for laboratory tests, including “Antibody to Hepatitis B surface Antigen,” “Blood Grouping Reagent,” “Reagent Red Blood Cells,” “Hepatitis B Surface Antigen” and “Anti-Human Globulin.” The presence of symbols accompanied by either explanatory text or a symbols glossary now also satisfies the labeling requirements for general purpose laboratory reagents (e.g., hydrochloric acid), analyte specific reagents (e.g., monoclonal antibodies, deoxyribonucleic acid (DNA) probes, viral antigens and ligands) and equipment (e.g., test tubes and pipettes).
The proposed rule can be accessed here. The FDA is accepting comments on the proposed rule through June 18, 2013.
If you would like to submit comments to the FDA or have questions about the regulation of medical devices, IVDs, biologicals or laboratory products, please contact Mark Dahlby at 414-721-0902 or mdahlby@hallrender.com or your regular Hall Render attorney.
