Label for product that's CE Marking approved, but waiting for US 510K approval

[KingQA]

Hi Everyone,

I'm pretty sure I know the answer to this question, but I wanted to double check with you all before moving forward. I have a product that recently received CE Marking approval for our IVD test kit, but is currently awaiting 510K approval from the FDA. Since we have the CE Marking approval, we intend to ONLY sell in Europe for now, until our 510K gets approved by the FDA. Does the label for the IVD needs to have "Investigational Use Only" (IUO) on it for the Kits we sell in Europe, while it's waiting for 510K approval? I realize that IUO needs to be on the label if it's being sold in the US.

Thanks for your help in advance.

 

[blewispunk]

No need to put investigational use only on the label if it is only sold in Europe prior to gaining 510k clearance in the US.

 

[sreenu927]

Yes, I agree with blewispunk.

 

[MIREGMGR]

I agree.

 

[Burgmeister]

but is currently awaiting 510K approval from the FDA.

Meanwhile in pedants corner.... PMAs get approval, 510(k)s get clearance.