Transfer Investigational Device Exemption (IDE) to New Sponsor

D

dblnkl

#1
1) Does anyone have experience transferring a feasibility IDE to a new sponsor? I understand that it is a relatively simple notification but would like to get confirmation and know if there are any pitfalls to watch out for.

2) That was the easy part. We also want to transfer technologies on this IDE. The two manufacturers' technologies are very similar (have the same lineage and may well share some major custom components) but the original technology is no longer available and we wish to continue the trial with the technology that is available. The original technology, obviously, has IDE approval. The new technology also has IDE approval, just for different IDEs/indications, and is actively under investigation (feasibility).
 
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Coury Ferguson

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#2
Re: Transfer IDE to New Sponsor

1) Does anyone have experience transferring a feasibility IDE to a new sponsor? I understand that it is a relatively simple notification but would like to get confirmation and know if there are any pitfalls to watch out for.

2) That was the easy part. We also want to transfer technologies on this IDE. The two manufacturers' technologies are very similar (have the same lineage and may well share some major custom components) but the original technology is no longer available and we wish to continue the trial with the technology that is available. The original technology, obviously, has IDE approval. The new technology also has IDE approval, just for different IDEs/indications, and is actively under investigation (feasibility).
I may be naive, but what does IDE stand for?
 
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