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

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Some Related Topic Tags
europe, fda (food and drug administration), labeling requirements, ce mark and ce marking, 510(k)
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  Post Number #1  
Old 7th April 2010, 05:57 PM
KingQA's Avatar
KingQA

 
 
Total Posts: 6
Please Help! Label for product that's CE Marking approved, but waiting for US 510K approval

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.

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  Post Number #2  
Old 7th April 2010, 06:23 PM
blewispunk

 
 
Total Posts: n/a
Re: Label for product that's CE Marking approved, but waiting for US 510K approval

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.
  Post Number #3  
Old 8th April 2010, 12:18 AM
sreenu927

 
 
Total Posts: 541
Re: Label for product that's CE Marking approved, but waiting for US 510K approval

Yes, I agree with blewispunk.
  Post Number #4  
Old 8th April 2010, 03:45 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Label for product that's CE Marking approved, but waiting for US 510K approval

I agree.
  Post Number #5  
Old 16th April 2010, 07:50 AM
Burgmeister

 
 
Total Posts: 105
Re: Label for product that's CE Marking approved, but waiting for US 510K approval

Quote:
In Reply to Parent Post by KingQA View Post

but is currently awaiting 510K approval from the FDA.
Meanwhile in pedants corner.... PMAs get approval, 510(k)s get clearance.
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