In an effort to harmonize US and international regulations, the FDA has released a final rule that gives manufacturers the option to use standalone symbols in medical device labeling.
Previously, the FDA required all symbols to be accompanied by explanatory text, unless the symbol was used on an in vitro diagnostic device intended for professional use. Under the new rule, no accompanying text is needed for symbols defined by national and international standards development organizations. However, a glossary of symbols must be included in the labeling.
According to the FDA, this change could financially benefit device manufacturers who do business internationally, especially for those who sell devices in the European Union (EU).
“Choosing to use standalone symbols under the final rule would potentially reduce the costs associated with designing and redesigning the labels on medical devices that are currently marketed in the United States and the EU,” the agency wrote in its final rule. “On average, companies that use standalone symbols under this final rule could expect to receive an average annual cost savings ranging from $1,500 to $4,500 per [device type].”
To accompany this rule, the FDA published a new standards-recognition notice that expanded the list of standalone symbols it recognizes. However, companies can use standalone symbols from standards not recognized by the agency if “the manufacturer 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 [Federal Food, Drug and Cosmetic Act (FD&C)] and uses the symbol according to the specifications for use set forth in the SDO-developed standard.”
Allowing manufacturers to decide if a symbol is “likely to be read and understood” is “consistent with what industry currently does when it uses text in labeling,” the FDA wrote, although the agency noted that it still has the authority to decide whether a symbol is in compliance with the rule.
The new rule does not require the use of standalone symbols, and manufacturers can continue to use symbols with adjacent explanatory text or choose not to use symbols at all. For organizations that want to change their labeling, this can generally be done without needing to submit a premarket approval (PMA) supplement. “PMA holders that implement this type of change should notify the agency of the change in the next annual report to the PMA,” the FDA advised.
To help industry and patient groups better understand the final rule and the new standards recognition notice, the FDA scheduled a free informational webinar on Monday, July 25, from 1 p.m.–2:30 p.m. ET. To listen to the presentation and ask questions, call (888) 469-0937 or (630) 395-0219 internationally (passcode: 1622312; conference number: PW8827759). And to access the slide presentation during the webinar, click here.
