Use of Symbols in Labeling: Frequently Asked Questions

Scope

1. Does the final rule apply to all symbols in labeling, or just those symbols that convey medical device information?
2. Does the final rule apply to product graphics? Is this different from instructional artwork, such as lines for alignment of components, or arrows indicating which way to turn a knob?
3. In the context of medical device software, does the final rule only apply to labels or also to symbols used elsewhere, such as directly marked on the product or used in a graphic user interface?
4. In the context of medical device software, does the arrow that is used as a navigational symbol need to be included in the glossary? What about other common iOS symbols like the "x" to close an application? Are those included?

Glossary and Identification of the Glossary Location

5. If a company is currently using text next to the symbols in its labeling, does it still need to have a symbols glossary?
6. The final rule requires that the glossary include (a) the symbol, (b) the title and designation number of the Standard Development Organization (SDO) developed standard, (c) the title of the symbol and its reference number, and (d) the meaning of the symbol. Are there copyright concerns with including this information from an SDO-developed standard?
7. What is the value of including the title of the standard, the designation number of the standard, or the reference number of the symbol in the glossary?
8. Does the statement identifying the location of the symbols glossary have to appear on the label?
9. What if I do not have a package insert and limited space on my label for additional text?

Use of other symbols

10. Can I use "homegrown" symbols, i.e., a symbol that is not established in a standard developed by a SDO, without adjacent text?

Implementation

11. May I revise my labeling to use symbols in accordance with the final rule during my next labeling update?
12. If I revise my labeling to use symbols in accordance with the final rule, am I required to submit a new 510 (k) or PMA supplement?
13. Will the FDA withdraw the final guidance, "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" from November 2004?
14. Is the FDA planning on issuing a new guidance document to assist in implementation of the final rule?
15. How is the FDA ensuring a consistent interpretation of the new rule among its own reviewers and inspectors?

Scope

1. Does the final rule apply to all symbols in labeling, or just those symbols that convey medical device information?

The Use of Symbols in Medical Device Labeling Final Rule ("final rule"), including the requirement for a glossary, only applies to symbols that are used to convey information required by or under the authority of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") to appear on the label or labeling for a device.  

2. Does the final rule apply to product graphics? Is this different from instructional artwork, such as lines for alignment of components, or arrows indicating which way to turn a knob?

The final rule only applies to the use of symbols in labeling. It does not apply to product graphics or pictograms, such as graphics showing the steps for using a device. In addition, the rule only applies to symbols that are used to convey information required by or under the authority of the FD&C Act to appear on the label or labeling for a device.

3. In the context of medical device software, does the final rule only apply to labels or also to symbols used elsewhere, such as directly marked on the product or used in a graphic user interface?

The final rule applies to symbols in the labeling for a device, including its label. Labeling is defined in section 201(m) of the FD&C Act to include "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying any such article."

4. In the context of medical device software, does the arrow that is used as a navigational symbol need to be included in the glossary? What about other common iOS symbols like the "x" to close an application? Are those included?

An arrow to advance to the next screen and the "x" to close an application are not symbols used to convey information required by or under the authority of the FD&C Act to appear on the label or labeling for a device. Therefore, they are not within the scope of the rule.

Glossary and Identification of the Glossary Location

5. If a company is currently using text next to the symbols in its labeling, does it still need to have a symbols glossary?

No.  A symbols glossary is not required for symbols used in labeling with adjacent explanatory text. The final rule provides manufacturers three options:

1. do not use symbols;
2. use symbols with adjacent explanatory text; or
3. use stand-alone symbols that have been established in a standard if, among other things, the manufacturer provides an explanation of the symbols in a symbols glossary that is included in the labeling for the device.

6. The final rule requires that the glossary include (a) the symbol, (b) the title and designation number of the Standard Development Organization (SDO)-developed standard, (c) the title of the symbol and its reference number, and (d) the meaning of the symbol. Are there copyright concerns with including this information from an SDO-developed standard?

The FDA is not aware of copyright concerns with listing this information in a glossary in labeling.

7. What is the value of including the title of the standard, the designation number of the standard, or the reference number of the symbol in the glossary?

The information helps assure compliance with the rule as it provides complete information regarding the source of the symbol. We encourage manufacturers for whom these requirements are problematic to contact CDRH, Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or DICE@fda.hhs.gov. The FDA will consider granting enforcement discretion on a case by case basis.

8. Does the statement identifying the location of the symbols glossary have to appear on the label?

No. Under the final rule, if a symbol used in labeling is not accompanied by adjacent explanatory text, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary. While a manufacturer may choose to put this statement on the exterior packaging, the rule does not require it. We expect many device manufacturers will choose to place the statement on labeling within the device package, so long as it is prominent and conspicuous.

9. What if I do not have a package insert and limited space on my label for additional text?

We recognize that some devices do not have labeling within the device package, and that some of these devices have limited space on their labels for additional text. We understand that some manufacturers of devices without package inserts, with limited label space, and with an electronic symbols glossary plan to identify the location of the symbols glossary through a url statement, e.g., http://www.devicecompany.com/symbols_glossary. In this example, the url statement is prominent and conspicuous on the label, the url provides the webpage of the electronic symbols glossary, and the words in the url statement that clearly identify the url as the location of the symbols glossary -- "symbols_glossary" – are written in English. We recommend manufacturers with further questions about the requirement for a statement identifying the location of the symbols glossary to contact CDRH, Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or DICE@fda.hhs.gov.

Use of other symbols

10. Can I use "homegrown" symbols, i.e., a symbol that is not established in a standard developed by a Standard Development Organization (SDO), without adjacent text?

No. Under the new rule, stand-alone symbols used in labeling must be established in a standard developed by an SDO. Therefore, in order for a manufacturer to use a "homegrown" stand-alone symbol in accordance with the final rule, that symbol would first need to be established in a standard by an SDO. "Homegrown" stand-alone symbols that are not established in a standard by an SDO are not permitted by the final rule. When a firm designs new labeling or updates existing labeling, it should not include "homegrown" stand-alone symbols.

Implementation

11. May I revise my labeling to use symbols in accordance with the final rule during my next labeling update?

Yes. The final rule explicitly allows for the optional use of stand-alone symbols in medical device labeling under certain circumstances. We do not expect manufacturers to change existing labeling, including labeling in inventory, for the sole purpose of updating their use of symbols. Manufacturers may revise their use of symbols in labeling as authorized by the final rule during their next labeling update. The FDA expects manufacturers developing new labeling to use stand-alone symbols as authorized by the final rule.

12. If I revise my labeling to use symbols in accordance with the final rule, am I required to submit a new 510 (k) or PMA supplement?

In most cases, manufacturers who wish to update their device or product labeling only by substituting text with one or more stand-alone symbols allowed under the rule, or to remove explanatory text adjacent to such symbols (without making any changes to the meaning of the labeling), do not need to submit a new premarket submission prior to making that change. Manufacturers may generally replace required information in existing labeling with equivalent stand-alone symbols that are allowed under the rule without the need to submit a PMA supplement, but notify FDA in the next annual report to the PMA.

13. Will the FDA withdraw the final guidance, "Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use" from November 2004?

Yes.  The FDA has withdrawn this final guidance. Manufacturers should look to the final rule, not the withdrawn 2004 guidance, when determining their use of symbols in new labeling and when making labeling updates.

14. Is the FDA planning on issuing a new guidance document to assist in implementation of the final rule?

No. At this time, the FDA does not intend to develop a general guidance document on the use of symbols in labeling. However, we encourage manufacturers to contact CDRH, Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or DICE@fda.hhs.gov if they have questions about implementing the new rule and if they believe that guidance would be helpful in their implementation of the final rule. We will consider adding any frequently asked questions to this website, consistent with FDA’s Good Guidance Practice regulation in 21 CFR 110.115.

15. How is the FDA ensuring a consistent interpretation of the new rule among its own reviewers and inspectors?

Appropriate FDA staff have received training on the final rule. We will continue to provide these FDA staff with updates as they are warranted through continual process improvement.