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Old 16th March 2006, 10:24 AM
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Question IFU Font size - Specified by any regulations for medical devices on sale in the US?
Can anyone please tell me if there are any regulatory requirements with regard to the font size on IFUs for medical devices on sale in the USA, or perhaps point me in th eright direction?



Thankyou in anticipation.
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Old 16th March 2006, 10:46 AM
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Originally Posted by suziwann

Can anyone please tell me if there are any regulatory requirements with regard to the font size on IFUs for medical devices on sale in the USA, or perhaps point me in th eright direction?



Thankyou in anticipation.
Look at the FDA web page on Medical Device Labeling Requirements. There are different requirements for OTC and prescription devices as well as requirements for specific devices (not necessarily font size). I think you will be able to find your way through the maze.
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Old 16th March 2006, 10:50 AM
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Thank you Al.
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Old 16th March 2006, 11:03 AM
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Thank you Al.
You're welcome.
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Old 17th March 2006, 08:46 AM
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Default Font Size
It appears that there are no specified font sizes for medical devices on sale in the US.
The only specification is 'legible' as far as I have found out.
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Old 17th March 2006, 10:11 AM
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Originally Posted by suziwann

It appears that there are no specified font sizes for medical devices on sale in the US.
The only specification is 'legible' as far as I have found out.
That is true for our devices too. I wasn't sure that it was true for all.
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Old 21st March 2006, 10:55 AM
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No, FDA does not suggest any font size. Obviously it must be readable, and I suggest to not use font size less than 6 pt.
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Old 24th March 2006, 08:52 AM
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I wish they would make the font legible on the shampoo bottles etc.
I just have to guess what to do as I get older.
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