Regulatory Open Forum

So, when FDA finally recognized 15223-1 in whole earlier this year, it was a reason to celebrate in that we could use the symbols without adjacent text.  This seemed like a no-brainer, so I didn't attend any webinars on the topic.  However, a colleague has called to my attention that FDA requires the use of TEXT on the package label to point to the location of the glossary.  Really?  I suppose this isn't a big deal for devices only sold in the US or only English speaking countries, but doesn't that defeat the whole purpose of using symbols AND defeat the purpose of symbols referring to the IFU?

I know that the 510(k)s in my world do NOT include this ridiculous statement and are going through RTA and SR just fine. 

What's your take on this?  Have you updated your box labels to include this statement?  Is there a chance that FDA will see the problem and fix it in the foreseeable future?

As an RA professional I want to be compliant, but I can't shake the feeling that updating all of our labelling just to add this statement isn't warranted and could be rolled in with other changes in the future. 

Looking forward to your comments!

Tina

So, where does one go to obtain these symbols for use in company documents?  I've not found any on the FDA website or other locations I've searched.

ISO 15223-1 can be purchased from AAMI, ISO, Tech Street or any other organization that sells standards. If you already use symbols on your labels, you likely already have this document available.

I also see that EN ISO 15223-1 is still not included in the list of standards harmonized under MDD per the europa website https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en; 

Only EN 980 is listed there.   Has anyone heard an update about plans to update that list with EN ISO 15223-1? 

John great information!!

Original Message:
Sent: 14-Dec-2016 15:14
From: John Beasley
Subject: FDA and Symbols Glossary Statement

Be careful ...  purchasing the standard does not give you access to artwork files that are ready to use when creating printed labels.  I advise - DO NOT do a Google Image Search and choose from files available online.  Also, the 3rd Edition of ISO 15223-1 was released 01 Nov 2016, so be sure you have the most recent copy when using this standard for conformity.

Camera-ready artwork of symbols are available from www.iso.org.  Simply go to the Online Browsing Platform (OBP),and  search for the symbol you want.  Alternatively, you can search for 15223-1 and the available symbols will be presented for your selection.  For example, the symbol for "method of sterilization, ethylene oxide" is Reference No. 2501 and is available for purchase in AI, DWG, and EPS formats.

John

Do you know if any of the symbols have changed or have been modified in the third edition? 

Thank you!!

Original Message:
Sent: 14-Dec-2016 15:14
From: John Beasley
Subject: FDA and Symbols Glossary Statement

Be careful ...  purchasing the standard does not give you access to artwork files that are ready to use when creating printed labels.  I advise - DO NOT do a Google Image Search and choose from files available online.  Also, the 3rd Edition of ISO 15223-1 was released 01 Nov 2016, so be sure you have the most recent copy when using this standard for conformity.

Camera-ready artwork of symbols are available from www.iso.org.  Simply go to the Online Browsing Platform (OBP),and  search for the symbol you want.  Alternatively, you can search for 15223-1 and the available symbols will be presented for your selection.  For example, the symbol for "method of sterilization, ethylene oxide" is Reference No. 2501 and is available for purchase in AI, DWG, and EPS formats.

The ISO standards listed below are the symbols that most manufacturers use on product labeling for U.S. products:

1. ISO 980
2. ISO 15233