FDA Issues Final Rule on Stand-alone Labeling

The FDA is allowing certain devices to carry stand-alone symbols on labels, in an effort to harmonize international standards used in medical device labeling.

In a final rule issued Tuesday, the agency is offering stand-alone symbols as an alternative to the agency’s current standards for medical devices, which allow for either text-only or a combination of text and symbols labeling. The changes seek to make labeling more user-friendly by replacing small and difficult-to-read text with symbols.

The option to use adjacent explanatory text is still available to manufacturers. In another significant change, FDA is now allowing the use of “Rx only” or “℞ only” symbol statements for prescription device labeling.

AdvaMed, the trade association that represents medical device manufacturers, applauded the long-awaited rulemaking. It specifically supported the language on stand-alone symbols, and another provision that would allow flexibility in the types of acceptable symbols devicemakers could use.

“Use of symbols in device labeling can help improve understanding and use of medical devices for both patients and physicians, and the agency’s final rule will encourage appropriate use of symbols,” Janet Trunzo, AdvaMed’s senior executive vice president for technology and regulatory affairs, told IDDM.

Streamlining International Labeling Practices

Previously, the FDA had not allowed devicemakers to use symbols in the labeling of their devices, unless they were accompanied by explanatory text — or if the symbol appeared on an in vitro (IVD) device that was being used in a professional capacity.

To harmonize U.S. device labeling requirements for symbols with international regulatory requirements, the medical device industry requested that FDA revise its regulations to allow for the use of stand-alone symbols in domestic labeling for devices.

The final rule sought to bring U.S. device labeling requirements in line with at least three international regulatory mandates: Medical Device Directive 93/42/EEC of the European Union; International Electrotechnical Commission (IEC) standard IEC 60417, and International Organization for Standardization (ISO) standard ISO 7000-DB, which regulates device symbols in a fair number of overseas markets.

U.S., EU Shared Symbols

Under the final rule, an exporter would be able to use the same set of stand-alone symbols on device labeling in the U.S. and the EU. This would save U.S. manufacturers who export medical devices to the EU significant resources associated with designing and redesigning labeling to include symbols with adjacent explanatory text to use in the U.S., according to the FDA.

The agency estimates that annual cost savings could start at more than $7 million and reach as high as $25.5 million, under certain discount rates.

As of Sept. 13, the date this rulemaking goes into effect, medical devicemakers will be able to use symbols in their labeling that incorporate a standard developed by a standards development organization (SDO) in the absence of text as long as the symbol meets requirements under Section 514(c) of the FD&C Act.

In the event a symbol’s standard does not meet Section 514(c) specifications or isn’t recognized by the FDA, the device maker must show that the average layperson could read and interpret the symbol.

“In addition, in either case, the symbol must be explained in a paper or electronic symbols glossary that is included in the labeling for the medical device,” FDA specified in the final rule.

Read the FDA rulemaking here: www.fdanews.com/06-15-16-DeviceLabelingRule.pdf. — Jennifer Lubell