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.

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. (http://www.fda.gov/cdrh/devadvice/33.html) 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.

Thank you Al. :)

Thank you Al. :)You're welcome.

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.

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.

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.

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.:o

Actually, for OTC, the allowable minimum type (font) size is 6pt. I don't know if shampoo are regulated too. By the way I found the guidance "HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING" which could help in writing labeling. Font size is not regulated, but here you can find some helpful suggestions.