IDE sponsor and investigator

#1
Hi everyone.

I have seen in several resources (including doi:10.231/JIM.0b013e318262df40 "Significant risk device studies require that the investigator also function as a sponsor and to file an IDE with the FDA for approval before starting.") that if the study is a Significant Risk device study, then the investigator (the PI in the hospital that will conduct the study) acts as a Sponsor too. Is that right?

So, to be clear - us, the manufacturing company that is sponsoring the study with Sponsored Research Agreement is not the Sponsor, rather the PI will be the Sponsor as well as the Investigator. and, consequently, all the communication with FDA (including study risk determination, pre-sub and IDE sub) will have to be done by the PI?

Many thanks in advance,
Dina
 
Elsmar Forum Sponsor
#3
I remember once you said you are an "Outside US" based company! Right! If so, then you aren't eligible to be a Sponsor anyway. See this for example. So, you will need "an U.S. agent" to play the role of a Sponsor.
Hi, thank you for responding! We are manufacturing the device outside the US, but we do have our US agent company
 
#5
Yes, then your US Agent company can play the role of "Sponsor". Talk to them, they may already know all the procedure.
Unfortunately, they don't. We have created that company to represent us and to be able to "perform on the US arena", but eventually the main company in Korea does all the stuff....

I have just been finding from a couple of resources that in SR device study, the investigator is also the sponsor.. so i was confused..
 

monoj mon

Quite Involved in Discussions
#6
Unfortunately, they don't. We have created that company to represent us and to be able to "perform on the US arena", but eventually the main company in Korea does all the stuff....

I have just been finding from a couple of resources that in SR device study, the investigator is also the sponsor.. so i was confused..
Just curious, don't you have any CRO involved in this IDE! If not, then I would recommend to get in touch with a suitable one. Being an outside US company, you may face many limitations if you don't have enough resources in your US company (as you said). For example, experienced person in your US office to play the role of Sponsor and follow the Sponsor's responsibility such as FDA and IRB approval, Investigator selection, Investigating device distribution to the investigator etc. If you don't have experienced people with relevant experience with IDE then you better hire a US based Consultant to be your US agent as well as the Sponsor for this IDE.
 
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