FDA's Newest Guidance Document: When the Label Doesn't Fit

Medical Device & Diagnostic Industry Magazine
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An MD&DI April 1998 Column

FDA is asking manufacturers to changelabel contentto include individualization of treatment and patient counseling.

Here we go again. Just when industry starts to believe its relationship with FDA can be cooperative, a new development occurs to remind us that FDA doesn't always consider the full impact its decisions will place on business.

At the recent Eighth Annual AAMI/ FDA International Standards Conference on Medical Devices, one of the sessions that triggered the most vocal response from attendees focused on the medical device labeling guidance document scheduled to be released in March.

From a consumer's perspective, the contents of the guidance document seem at first glance to be a positive change. FDA intends to encourage manufacturers to develop more useful and more user-friendly labels that emphasize information gathered during clinical trials while promoting uniformity and clarity in labeling. In addition, a new one-page summary of Highlights of Labeling Information (HLI) would provide concise data for physicians, a Cliff's Notes version of the full medical device instruction. (Apparently, physicians are the raison d'être for this entire document. FDA believes few doctors actually read the labeling information that accompanies devices. Strange that the agency doesn't address this issue with physicians directly.)

A closer look reveals some flaws in the ways this seemingly more useful labeling would be created. While providing uniformity, clarity, and direction consistently across all medical device labeling is a worthy goal, common headings and symbols would likely be sufficient. But FDA is asking manufacturers to change label content to include individualization of treatment and patient counseling—areas for which physicians should be taking responsibility. Suggesting that manufacturers employ bullets and white space more effectively in the labeling would make labels more readable, but the expense of doing so, and of doing so soon, is excessive. Although the HLI appears to be a time-saver for physicians, I'd prefer that my doctor read the full instructions for any device that might affect me rather than a one-page cheat sheet. Requiring manufacturers to update these one-page summaries every six months seems excessive as well.

And, as members of the audience were quick to point out, the timing for this new initiative couldn't be much worse: Not only are manufacturers whose products contain latex already redoing labels, but everyone who would like to sell a device in Europe starting June 14 is translating labels into 10 languages to meet European Union requirements. Requiring additional changes at this time could very well be overload.

But perhaps what's most troubling about this entire guidance document is the perceived lack of attention FDA has paid to industry feedback. Since its notice of availability was published in the August 1, 1997, Federal Register, industry has sent in more than 200 pages of comment. According to Marlene Tandy, HIMA's director of technology and regulatory affairs and associate general counsel, it appears that very few, if any, of the comments have been incorporated, at least in the version that Dan Spyker, deputy director of the Division of Cardiovascular, Respiratory, and Neurological Devices in CDRH's ODE, presented at the AAMI meeting. By the time you read this, the final version of the guidance document should have been released, so right now it may be premature to say FDA blatantly ignored industry's concerns. But if that is the case, it unfortunately appears we've taken a step back toward the more-contentious relationship that prevailed in the past.

Stacey L. Bell

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