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Warnings/Cautions in Medical Device IFU

#1
Hi all,

Apologies in advance if this is posted in the wrong section. We are developing a handheld active medical device that includes hardware and software. Are there any standards (Electrical, Safety, Regulatory) that dictate that warnings/cautions or indications for use need to appear at the beginning of the IFU or can we decide where best to position these statements? Our target markets are U.S, Canada, EU.

Thanks in advance!
 
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#2
Are there any standards (Electrical, Safety, Regulatory) that dictate that warnings/cautions or indications for use need to appear at the beginning of the IFU
So far I am not aware of such standard or guidance mentioning the above statement. Usually, the standard practice is to place the Intended Use, Indications for Use at the beginning of the IFU while you can put warning/cautions statements anywhere at the following sections.
 
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