FDA Guidance on 'Latex-Free' Labeling Issued Today - March 2013

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M

MIREGMGR

#4
It's only a draft at present. Even if what it proposes eventually will be implemented unchanged, it's not effective yet.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
...and anyway it's just a recommendation (though one you probably don't want to refuse :)). Not sure that there's a current regulatory basis to ban the existence of "latex-free"-type labeled devices on the market; if this is true then safety field action would probably be at the manufacturer's discretion. If I'm wrong, the total consequences are likely to be huge :mg:. Just think of all the sterile disposables...
 
A

Adele

#6
It is also good to see the FDA get some consistency on this. We changed the wording in a 510(k) to what the reviewer wanted but in the next 510(k) submitted a month later (where we used the wording) we were told to change it again.
 

dzurn

Starting to get Involved
#7
We had the same pushme-pullyou from the FDA on this issue, so the guidance is a real relief.

We've been trying to avoid the term "Latex Free" and using the earlier suggested FDA wording, but frankly this new guidance matches what we can really guarantee while meeting our customer demand for Latex-content information, one way or another.

Just last month we were considering different uses of our Latex FRee symbol for different countries, but now it looks like one labeling scheme will still work in regards to Latex-freedom labeling.
 
G

gas313

#8
Hi. We have been using the round edged, upside down triangle with the word "LATEX" crossed out and the words "Latex Free" under it as our latex free symbol. We are thinking about using the same symbol except the words "latex free" will change to "Not Made With Latex" (a shorter version of the FDA's recommendation). I was wondering what you guys think about this? Thanks.
 
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