September 29, 2016
By: Antoinette (Tosia) Hazlett, MSN, RN, and Scott Colburn CAPT, USPHS
Antoinette (Tosia) Hazlett, MSN, RN, Senior Policy Analyst at FDA’s Center for Devices and Radiological Health
Scott Colburn CAPT, USPHS, FDA’s Director, Center for Devices and Radiological Health Standards Program
Symbols convey important messages for navigating everyday life; whether it’s a traffic sign or a graphic image indicating that no smoking is allowed in a building. Symbols in medical device labeling can also convey important information. However, to be an effective means of communicating information, it’s critical that symbols on medical devices are understood by the individuals who use them.
In June, FDA issued the Use of Symbols in Labeling final rule, which describes the circumstances in which manufacturers can use a stand-alone symbol in device labeling without any adjacent explanatory text. For example, if certain requirements are met under the final rule, manufacturers of sterile syringes could opt to use the symbol for “do not reuse” on a syringe package without adding the actual words “do not reuse” to the package.
The "Use of Symbols in Labeling” final rule which went into effect on September 13, 2016, does not mandate the use of stand-alone symbols in device labeling. Under the final rule, device manufacturers have three options. They can choose not to use symbols, use symbols with adjacent explanatory text, or use stand-alone symbols that have been established in a standard if certain requirements are met, including providing an explanation of the symbols in a symbols glossary that is included in the labeling for the device.
Adding the option of stand-alone symbols is expected to reduce design costs for manufacturers because it is more consistent with how devices are currently labeled in Europe and other foreign markets. Replacing small and difficult-to-read text with a symbol will also help make some labeling more user-friendly and understandable. That is critical in medical device labeling, where space may be limited. The use of stand-alone symbols on a global scale may help promote better understanding through consistent labeling across products distributed in the U.S. and foreign markets.
Before this rule, FDA recognized five consensus standards that address the use of stand-alone symbols. On the same day this rule was issued, FDA updated its currently recognized consensus standards list and added three new standards containing more symbols in a published standards-recognition notice.
The required symbols glossary is intended to help users become familiar with the meaning of the stand-alone symbols and serve as a reference for users to look up any definitions they may not recall.
The symbols glossary may be in a paper or electronic format as long as it is included in the labeling for the device. Additionally, the labeling on or within the package that contains the device must bear a prominent and conspicuous written statement identifying the location of the symbols glossary.
Symbol Statement “Rx Only” or “℞ only”
The rule also allows for the use of the commonly used symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
On Monday, July 25, 2016, FDA conducted a webinar to help industry and patient groups learn more about this final rule and the new standards recognition notice. The slides, recording and transcript from the webinar entitled, “Final Rule: Use of Symbols in Labeling” is available on the CDRH Learn and Webinar webpages.
Antoinette (Tosia) Hazlett, MSN, RN, is a Senior Policy Analyst at FDA’s Center for Devices and Radiological Health
Scott Colburn CAPT, USPHS, is FDA’s Director, Center for Devices and Radiological Health Standards Program