FDA has recently proposed allowing primary labels on medical devices to have symbols without accompanying English text. For medical devices sold in Europe, for
example, primary labels can have symbols without any textual explanation
adjacent to the symbol on the device primary label (per ISO 15223-1:2012, “Symbolsto be used with medical device labels, labeling and information to be supplied-Part 1: General requirements). Examples of such symbols are shown below:
The proposed changes would affect medical devices,
biologics, and in vitro diagnostics as regulated by 21 CFR Parts 660, 801, and
809, and would allow certain symbols to “stand alone” on primary labeling so
long as a glossary with symbol explanation accompanies the product - think in the Instructions for Use document.
This proposed change could help the industry in two ways:
make the label more user friendly (no ridiculously small text next to each
symbol on the label) and would harmonize the labeling requirements between U.S.
and foreign regulatory agencies (i.e.,
companies could potentially use the same primary label and wouldn’t have to
develop and use separate primary labels for U.S. and European markets).
See links below for more information.
Federal Register (Volume 78, Number 76: Friday, April 19,
2013)
“FDA Proposes to Harmonize Medical Device Labeling” – FDA Law
Blog (summary article)
ISO 15223-1:2012, “Medical devices – Symbols to be used with
medical device labels, labeling and information to be supplied – Part 1:
General requirements”.
21 CFR Part 660, Additional Standards for Diagnostic
Substances for Laboratory Tests (biologics)
21 CFR Part 801, Labeling (medical devices)
21 CFR Part 809, In Vitro Diagnostic Products for Human Use
(in vitro diagnostics)
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ReplyDeleteThank you for your article.
ReplyDeleteI was wondering from which standard is taken the symbol "For professional use only"...I couldn't find it in the ISO 15223-1:2012 or ISO 9687:2015
Kind regards
This is not a harmonized symbol. It's seems to be made up by a company named LeonAmerica (*https://www.leoneamerica.com/quality-info/)
DeleteThe label on the package of any medical device set on the market will show the symbols in compliance with the harmonized standards.
The symbols marked with a single (*) are based on the ISO 21531, ISO 15223-1 and on the 93/42EEC Directive. The symbols marked with double (**) have been instead adapted by Leone.