Does FDA have regulations about Braille use for Medical Device

Y

yarina

#1
Dear all:

Is there any regulations or guidance about braille use for medical device in FDA?

Thanks:thanx:
 
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Wes Bucey

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#2
Re: Does FDA has regulations about Braille use for medical device

Dear all:

Is there any regulations or guidance about braille use for medical device in FDA?

Thanks:thanx:
Not currently. lots of talk over the years, but it seems there is not a sufficient number of users of drugs and devices who are capable of reading Braille to trigger a mandate that ALL drugs and devices have Braille labels.

I seem to recall, but can't cite a definitive source, in which FDA agrees specific devices and/or drugs prescribed to be used or administered by persons who read and understand Braille may (not "shall") carry an additional label in Braille. There are also some drugs and devices which have a "talking label" for folks unable to read a label for sight or literacy purposes.

Simplest solution to your question is to address it to FDA directly.

I am vaguely aware the the European Union has some labeling requirement for Braille, but your question was directed at FDA requirement.
 

pkost

Trusted Information Resource
#3
Re: Does FDA has regulations about Braille use for medical device

There may be a requirement in the EU for pharma as I have seen more drug boxes with braille on them, however there is not requirement for Braille as such for in medical devices yet. If however you manufacture an end user medical device for the the blind then you would have difficulty demonstrating compliance with some of the ER's if you didn't use braille
 
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