Regulatory Open Forum

Hi, I had a question in regards to intended use vs indications for use. 

Our device is a rigid suction cannula (Yankauer/Frazier styles) to be used during surgery. We originally considered that there is no indications for use, only an intended use (suction of fluids/debris). During a tech file audit, the auditor did not agree that there is no indications for use and the claim for no indication has not been fully supported.

Before updating all files to change from "Intended Use" to "Indications for Use", I wanted to reach out to you folks to see if there is any supporting evidence that a standard of care device, such as the rigid suction cannula, would only have an "intended use" and not an "indication for use".

Any direction or guidance is greatly appreciated.

Thanks

Hi,

I have worked with MDR devices where Intended use and indication use is very much emphasized upon. 

my thinking is as follows- 

Yankauer/Frazier styles- indicated to be used in general and emergency surgeries.

intended to remove fluids, blood, and other debris during surgical or medical procedures.

Hi, I had a question in regards to intended use vs indications for use. 

Our device is a rigid suction cannula (Yankauer/Frazier styles) to be used during surgery. We originally considered that there is no indications for use, only an intended use (suction of fluids/debris). During a tech file audit, the auditor did not agree that there is no indications for use and the claim for no indication has not been fully supported.

Before updating all files to change from "Intended Use" to "Indications for Use", I wanted to reach out to you folks to see if there is any supporting evidence that a standard of care device, such as the rigid suction cannula, would only have an "intended use" and not an "indication for use".

Any direction or guidance is greatly appreciated.

Thanks