Medical Device Clinical Trial Labels

PPcricket

Starting to get Involved
#1
Hi there, I have a quick query on the labelling for clinical trial medical devices.

I wanted clarification on which address should go onto a clinical trial label when you use a sub-contractor to manufacture your product.

My understanding is that it should be the 'manufacturer' which is my company even though we sub-contract the manufacture, is this correct.

The product will be for the US market and the clinical trial material is to be shipped over there. I have heard some contradicting information from mt understanding hence i would be grateful for clarification?

Regards,P
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Yes, you are correct, you as the product marketer are the Manufacturer per FDA rules, and you must be identified on the product labeling as the responsible party.
 

PPcricket

Starting to get Involved
#3
One thing I forgot to mention is that we still due to gain our cert for ISO13485 & OBL (own brand labelling), due in the coming months, does that change anything in terms of the labelling of the device for the clinicals?

Thanks, P
 
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