Use of Symbols in Labeling
Food and Drug Administration; 21 CFR Parts 660, 801, and 809; [Docket No. FDA-2013-N-0125]
June 15, 2016
The Food and Drug Administration (FDA or the Agency) issued the final rule below revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met.
The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
- This rule is effective September 13, 2016.
Final Rule in Federal Register (21 Pages in PDF)
The FDA also published a new standards-recognition notice that modifies the Agency’s current list of recognized standards containing stand-alone symbols to extend the recognition of six standards and to recognize three new consensus standards containing many more stand-alone symbols.
July 25, 2016, the FDA will hold a webinar to help Industry and patient groups understand this final rule and the new standards recognition notice.
- Date: July 25, 2016
- Time: 1:00 PM – 2:30 PM ET
- To hear the presentation and ask questions:
- To view the slide presentation during the webinar: https://www.mymeetings.com/nc/
Industry Comments on Stand-alone Use of the Symbols
Four comments requested that FDA authorize stand-alone use of all the symbols contained in ISO 15223-1:2012. One of these comments also encouraged the Agency to consider authorizing stand-alone use of the symbols in international standards ISO 7000, ISO 7010, and IEC 60417; another asked us to clarify that authorized stand-alone use will include the symbols in ANSI/AAMI ES60601-1:2005 and supersede IEC 60601-1. A separate comment recommended authorizing stand-alone use of the symbols in “ISO standard BS EN 980.”
As explained earlier in the Background section and section II.A (FDA response to Comment 1), this final rule provides additional flexibility by permitting the standalone use, in device labeling, of symbols that are part of a standard recognized by FDA under section 514(c) of the FD&C Act, as specified in the proposed rule, or, alternatively, a manufacturer can use an SDO*-established symbol not included in a standard recognized by FDA or a symbol in a standard recognized by FDA but not used in accordance with the specifications for use of the symbol set forth in FDA’s section 514(c) recognition, if it otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act.
Because FDA recognition of the underlying standard is not the only option for manufacturers, they are free to choose to select the additional option provided by the final rule with regard to using symbols established in the standards referenced in the comments. (See also section III regarding compliance and enforcement).
*: SDO: standards development organization (SDO)
Download the Pre-Publication Final Rule in PDF (80 Pages)
The rule is effective 90 days after date of publication in the Federal Register.
Last Updated: 2016-05-16