Crash Those Symbols - FDA Proposed Rule

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!

According to the proposed rule, dated April 15, 2013, the FDA is proposing the revision of 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)... 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.1

The development in the regulations is expected to simplify product labeling for many manufacturers, especially those selling in countries / regions that currently allow the use of symbols in medical device labels. Instead of now labeling products with the same information two and three times over, the use of symbols should simplify labeling design by using the symbol once to meet the requirements for several countries / regions. Maybe my pessimism over harmonization in last week's post about crowd sourcing was over stated?

A potentially more critical aspect of this post is that the comment period remains open until June 18, 2013. It is again another opportunity for industry to collaborate with the agency and help to craft a regulatory structure that benefits patients, end users, regulators, and industrial representatives. Details on how to comment on the proposed rule are included in the document (linked above).

Happy reading / commenting!

-RTK

1 Federal Register Volume 78, Number 76 (Friday, April 19, 2013), Pages 23508-23515, <http://www.gpo.gov/fdsys/pkg/FR-2013-04-19/html/2013-09175.htm?source=govdelivery>

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