Indications for Use - Is it possible to have a different indication for use

[Sphinx]

Is it possible to have a different indication for use for the same device in the EU and the US?

 

[Ronen E]

Is it possible to have a different indication for use for the same device in the EU and the US?

Yes, it’s possible.

 

[Highground]

Can you have two different indication for use in the same IFU if you separate the sections per country?

This is based on a device that has CE in the EU for a special fluid and a device that will be submitted to FDA soon, but with the addition of the special fluid and water. Will these identical devices need different production codes as well.

 

[mihzago]

FDA will most likely not allow it. You should create separate documents.