K
kenyon85
Dear all,
I would like to get the view of the Cove community on the following UDI question. There is a 510k cleared device placed on the US market. The device has a slightly different Intended Use as the CE marked EU version does. If the EU version is being adopted again for the purpose of an clinical investigation Phase I in the US does this need to be UDI labeled? The 510k will be referenced in the IND submission with FDA. Please let me know your thoughts about this.
Regards.
I would like to get the view of the Cove community on the following UDI question. There is a 510k cleared device placed on the US market. The device has a slightly different Intended Use as the CE marked EU version does. If the EU version is being adopted again for the purpose of an clinical investigation Phase I in the US does this need to be UDI labeled? The 510k will be referenced in the IND submission with FDA. Please let me know your thoughts about this.
Regards.