Originally Published IVD Technology March 2005
INDUSTRY NEWS
FDA guidance stirs hope of labeling progress
Matt Grebow
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| Four of the 25 symbols that FDA has approved for use on IVD labels for professional users. Clockwise from left: caution, consult accompanying documents; contains sufficient for < n > tests; consult instructions for use; and biological risks. |
Following a relatively quiet comment period, FDA has released its final guidance on the use of symbols for IVD labeling. The provisions in this document allow IVD manufacturers to choose from among 25 widely recognized symbols when labeling products for professional users.
The new guidance, “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use,” is nearly identical to the agency’s October 2003 draft guidance. However, FDA removed an earlier proposal to exercise enforcement discretion if companies used a manufacturer symbol to satisfy distributor information required under 21 CFR Part 610.64.
The drive to adopt standardized symbols on IVD labels has largely been supported, and even directed, by the IVD industry. Following the 1998 enactment of the European Union’s Directive on In Vitro Diagnostic Medical Devices, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety expressed a willingness to revisit the labeling issue if the industry could prove that professional IVD users were familiar with the symbols. In response, industry association AdvaMed (Washington, DC) conducted a human factors study on symbol comprehension. Based on the results of that study, FDA issued its draft guidance on the use of symbols.
“I think industry would generally welcome the acceptance of these new symbols to reduce the length of IVD labeling that requires multiple languages,” says Katie Smith, PhD, senior director of diagnostics clinical research and regulatory affairs, Prometheus Laboratories (San Diego). “This guidance is one more manifestation of the regulatory movement toward globalization of medical devices.”
Although the report reconciles some long-standing complaints by the IVD industry about the limitations of label space and the costs associated with creating country-specific packaging, concerns remain about whether the FDA guidance goes far enough. For example, FDA decided to uphold its recommendation that a symbols glossary be incorporated into the package insert rather than included as a separate labeling piece.
Questions have also been raised about whether the list of 25 symbols will be enough to satisfy future labeling demands. “The multiple-language requirement is still a huge problem,” says Don Powers, PhD, president and principal consultant of Powers Consulting Service (Pittsford, NY). “Ten more countries just joined the EU last year, potentially increasing the number of official languages that could be required from 11 to 20. More symbols would help, but all the easy ones have been developed and, as far as I know, there are no standards bodies investigating possibilities for new ones.”
Although the FDA guidance may represent a step in the right direction, assembling agreed-upon global IVD labeling standards would likely render further FDA labeling guidance unnecessary. FDA has been working with the Clinical and Laboratory Standards Institute (Wayne, PA) in an effort to do just that, in the form of standards compiled for the International
Organization for Standardization (ISO; Geneva). Powers, who oversees the IVD-focused working group of ISO technical committee 212 (TC212), says that the goal of international labeling harmonization is well on track. In January, TC212 released three committee drafts of the ISO labeling standards. In May, TC212 will begin the process of addressing comments received from participating countries. If all goes well, a draft international labeling standard could be voted on by the ISO membership six weeks after that.
“We all hope the standard will meet everyone’s needs and it won’t be necessary for FDA to issue additional guidance, other than to follow the international standards,” says Powers. “In the end, if there are points that the standards do not address, then FDA will issue specific guidance to fill in what it perceives to be gaps. So far, I am optimistic that won’t be necessary.”
FDA’s final guidance on the use of symbols in IVD labeling can be accessed via the agency’s Web site at www.fda.gov/cdrh/ocd/guidance/4444.html.
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