Monday, April 29, 2013

FDA Proposes Change to Device Labels: Symbols Without Text


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)


3 comments:

  1. ?I was more than happy to find this web-site.I wished to thanks in your time for this wonderful read!! I positively enjoying every little little bit of it and I've you bookmarked to take a look at new stuff you weblog post. gsn casino slots

    ReplyDelete
  2. Thank you for your article.
    I 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

    ReplyDelete
    Replies
    1. This is not a harmonized symbol. It's seems to be made up by a company named LeonAmerica (*https://www.leoneamerica.com/quality-info/)

      The 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.

      Delete