Devices

CDRH Discusses Symbols in Device Labeling as Rules Becomes Effective

Beginning next month (9/13), CDRH will allow the use of stand-alone symbols without adjacent text on domestic device labeling, making it consistent with symbols used on devices manufactured for European and other foreign markets. The Center conducted a 7/25 webinar to discuss its final rule on the symbols.

According to Center officials, The scope of the symbols rule includes allowing manufacturers the option to use symbols alone, symbols with adjacent explanatory text, or no symbols at all. If symbols are used, a symbols glossary is required and it may be in paper or electronic format. It also allows for the use of the symbol statement “Rx only” for prescription device labeling.

In order to use stand-alone symbols, they should be from a standards development organization’s (SDO) standard that is recognized by FDA, according to CDRH policy analyst Tosia Hazlett. “If the stand-alone symbol is an SDO standard, but the standard is not recognized by FDA, or the symbol is not used according to the specifications for use put out in the FDA recognition, manufacturers may themselves determine whether the stand-alone use of the SDO-established symbol complies with the Food Drug and Cosmetic Act, Section 502(c),” she said. “This means that the manufacturer determines that the symbol is likely to be read and understood by the customary users of the device. This would be consistent with how industry makes other labeling decisions in terms of compliance with other FDA statutes and regulations.”

The symbols glossary should be a compiled listing of each SDO established symbol used in the labeling for the device, the title and the designation number of the SDO developed standard containing the symbol, the title of the symbol and its reference number, if any, in the standard, Hazlett said. It should also include the symbol’s meaning or explanatory text of the symbol as provided in the FDA recognition. “Additionally the labeling on or within the package containing a device must bear a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English,” she said.

And if a device sponsor elects to use a standard for using a symbol that is recognized by the agency, then a “declaration of conformity that certifies that their device is in conformance of such standard and that they may use data or information from that standard to support the requirements under which part of the Act they’re utilizing,” added CDRH Standards Program director Scott Colburn.

To view a replay of the webinar, click here. To view a transcript of the webinar, click here.

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