Intended use/Indications use for Foley Catheter

[destroyed9218]

Hi, can anybody comment if Intended Use or Indications use statement is needed in IFU for foley catheter? Also, please redirect to the FDA requirement.

 

[DanMann]

Not sure about a foley catheter specifically, but in general FDA CFR 21 801.4 and 801.5 talk about the necessity to included the intended use in the labelling of a medical device.