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
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.