FDA Proposes to Allow Stand-Alone Use of Symbols on Labels

When designing labels for worldwide product distribution from Europe, it has long been frustrating that the FDA required well-known symbols to be accompanied by adjacent explanatory text.

 Rolande Hall

I am delighted to be able to tell you all that the FDA, on April 19, 2013, has released a proposed rule that it summarises as:

The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a 'standardized symbol') and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device.

From my perspective, the sooner this happens the better, especially the main part of the rule, which will enable much de-cluttering of package labels. Anything that makes it easier for the user to quickly and accurately read medical device labels has to be applauded. We cannot directly measure the effect, but de-cluttering can be expected to reduce interpretation errors and hence improve patient safety.

At this time, I offer my full support to this proposal and look forward to the next stage when the symbols glossary can also be despatched into history.

Stay relevant as a medical device packaging engineer

Rolande Hall, FIMMM Pkg Prof

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