Device Labeling - Stand Alone Symbols of ISO15223 no longer FDA recognized

lboll

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In the latest Federal Register update to the FDA Recognized Consensus standards (http://www.gpo.gov/fdsys/pkg/FR-201...ivery&utm_medium=email&utm_source=govdelivery), the FDA has taken exception to clause 4.2, Requirements for Usage, of ISO 15223-1 (http://www.accessdata.fda.gov/scrip.../detail.cfm?standard__identification_no=32636).

Therefore, the FDA is stating that stand along symbols are no longer acceptable on product labeling. The FDA has told us on a recent 510(k) submission that explanation of the symbols in the IFU is not enough - the label itself must have the explanatory text next to each symbol.

This is easy enough to do on new products, but is a huge undertaking for all existing labels. I'd like to just incorporate this into our UDI project and put off making the changes until then.

How is everyone addressing this?
 
M

MIREGMGR

In the latest Federal Register update to the FDA Recognized Consensus standards (http://www.gpo.gov/fdsys/pkg/FR-201...ivery&utm_medium=email&utm_source=govdelivery), the FDA has taken exception to clause 4.2, Requirements for Usage, of ISO 15223-1 (http://www.accessdata.fda.gov/scrip.../detail.cfm?standard__identification_no=32636).

Therefore, the FDA is stating that stand along symbols are no longer acceptable on product labeling. The FDA has told us on a recent 510(k) submission that explanation of the symbols in the IFU is not enough - the label itself must have the explanatory text next to each symbol.

This is easy enough to do on new products, but is a huge undertaking for all existing labels. I'd like to just incorporate this into our UDI project and put off making the changes until then.

How is everyone addressing this?

Nothing about this is new except FDA's efforts to "spread the word". Freestanding-symbol use has been implicitly prohibited by FDA since 1976 (because it's not "English language", with the justification that American users are not familiar with the symbols involved), though there was no effort to enforce that rule for Class I devices. The 2004 guidance "Use of Symbols on Labels (...)" allowed symbol use only on professional use IVDs, though only a subset of the standards' label ranges, and though FDA's internal stance on even that limited use was very inconsistent.

My observation has been that FDA in the past decade or so has had some sort of internal dispute between Traditionalists and Pro-Harmonization factions, with the latter being pro-ISO-standards including in regard to labeling.

FDA's 2013-14 regulatory agenda included as an action item "Use of Certain Symbols in Labeling", with a finalization date of April 2014. As far as I know, this did not occur as a final rule, though there has been additional discussion.

My understanding continues to be that most FDA personnel, except for some Traditionalists, will accept ISO symbols on professional-use non-IVD device labels if readably-sized English subtext is provided under them. That's what I have my label tech do to create our global labeling. It's an imperfect approach according to anyone's system, but so far no one has prohibited it, at least for us.
 
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