FDA Issues Final Rule on Use of Symbols in Labeling

| Printer friendly version

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory text if certain requirements are met.  This rule is intended to better conform U.S. labeling requirements for symbols with regulatory requirements in European and other foreign markets.

The final rule allows symbols established in a standard developed by a standards development organization to be used in medical device labeling without adjacent explanatory text if (1) the standard is recognized by the FDA and the symbol is used in accordance with certain specifications for use set forth in the Food and Drug Modernization Act of 1997 or (2) the device manufacturer otherwise determines the symbol is likely to be read and understood by an ordinary individual under customary conditions of purchase and use in compliance with certain misbranding stipulations under the Federal Food, Drug, and Cosmetic Act and the manufacturer uses the symbols according to specifications for use set forth in the standards development organization’s developed standard.

Examples of international consensus standard symbols can be found in “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use,” an FDA Guidance Document issued on November 30, 2004, that recognized 25 symbols from two international consensus standards for IVD devices for professional use.  Symbols from that Guidance Document are reproduced below:

Capture2

This final rule is estimated to lead to cost savings between about $7.9 million and $25.5 million for medical device manufacturers and will go into effect on September 13, 2016.

Brian Flynn
Brian Flynn focuses on patent preparation and litigation. He counsels clients in a wide variety of technologies, including: · Medical Device: medical and dental instruments, implants, diagnostic equipment, and communication and data systems · Mechanical: automotive technology, sporting goods, kitchen appliances, beverage containers, and toys · Electronics: digital camera technology, mobile devices, GPS devices, and sensor technology Brian received his law degree from the University of Illinois College of Law, where he served as the Secretary for the Intellectual Property Legal Society and as an Articles Editor for the Journal of Law, Technology & Policy. Prior to his legal education, he received a Bachelor's Degree in Bioengineering from the University of Illinois.
Click here to read full bio
View all posts published by Brian Flynn »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.