FDA Issues Final Rule on Symbols for Device Labels
Posted 15 June 2016 | By
The US Food and Drug Administration (FDA) on Wednesday issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards.
In addition to allowing the use of standalone symbols, the final rule also permits the use of the symbol statements "Rx only" and "℞ only" for prescription devices.
FDA says the finale rule is optional, though the agency thinks that it will be a boon to industry and estimates the reduced workload will result in annual savings of up to $25.5 million.
In the past, FDA prohibited companies from using standalone symbols on device and IVD labels, and required symbols on the labels to be accompanied by explanatory text.
However, in 2013, after pressure from the medical device industry, FDA issued a proposed rule that would allow standalone symbols to appear on device labels for public comment. In its comments on the proposed rule, the Advanced Medical Technology Association (AdvaMed) called FDA's previous approach inefficient, saying that "adding adjacent English text eliminates the inherent advantage of using internationally recognized symbols."
Now, under the final rule, the agency will allow the use such symbols, as long as they meet certain requirements.
As with the proposed rule, the final rule requires that all standalone symbols be explained in a paper or electronic glossary included with the device, despite industry requests to eliminate the glossary requirement. Commenting on the proposed rule, AdvaMed requested that FDA drop the glossary requirement, as such a glossary is not required under the EU Medical Device Directive.
However, in a major departure from the proposed rule, the final rule allows manufacturers to use standalone symbols not recognized by FDA in addition to those that are developed by recognized standards development organizations (SDOs).
Under the final rule, a SDO is defined as "an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope."
Specifically, FDA says companies can still 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."
According to FDA, allowing manufacturers to decide for themselves if a symbol is likely to be read and understood is "consistent with what industry currently does when it uses text in labeling," though the agency notes it still has authority to determine whether a symbol is in compliance with the rule.
Additionally, the agency says this gives it and industry, more leeway in situations where FDA has not yet recognized a new revision of a standard.