Hello,
I have just started a position with an EU-based medical device company who are running a clinical investigation in the US. I have no personal experience of clinical studies and I am please looking for some experience from the community on these to further my thinking:
1. Are NSR studies deemed IDE studies?
Reading FDA information suggests NSR studies, and not just SR studies, are IDE studies, albeit NSR studies only follow abbreviated IDE regulations. The IRB, in agreeing with the Sponsor NSR determination, approve the IDE request. FDA do not need to get involved.
2. NSR study sponsor must be US based?
FDA's website states "A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations." If an NSR study is an IDE study, then our EU office cannot be the sponsor for the sites in the US? Or is this FDA statement specifically in relation to the party who submits an IDE application to FDA for SR study?
As this is from FDA website and not a CFR, is this really a requirement?
3. US office can be PO box only?
The US office, if required, does not need a physical presence - it can be set up as a PO box?
If just a PO box, how does the US office act as sponsor? The contracts, insurance, finance, personnel, TMF etc. can all be agreed and held by the EU office?
4. EU office can ship directly to US sites?
If there is no US office, the investigational devices are shipped directly to the sites. Do the sites assume the role of the importer and therefore, agent & sponsor as by FDA:
"(a) Imports. In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation."
Where do these roles, relationships and responsibilities need to be documented and reported? Can a PO box assume these roles?
As this provision is taken from the General Provisions, and is not called out as being one of the provisions that must be followed for an NSR study (abbreviated IDE regulations), does this apply to NSR studies?
5. Medical/Investigational devices can be shipped to private residence?
While everyone is working from home, are there any rules around shipping medical devices/investigational devices to private residences in the US from outside/within the US?
Thanks to all in advance
I have just started a position with an EU-based medical device company who are running a clinical investigation in the US. I have no personal experience of clinical studies and I am please looking for some experience from the community on these to further my thinking:
1. Are NSR studies deemed IDE studies?
Reading FDA information suggests NSR studies, and not just SR studies, are IDE studies, albeit NSR studies only follow abbreviated IDE regulations. The IRB, in agreeing with the Sponsor NSR determination, approve the IDE request. FDA do not need to get involved.
2. NSR study sponsor must be US based?
FDA's website states "A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations." If an NSR study is an IDE study, then our EU office cannot be the sponsor for the sites in the US? Or is this FDA statement specifically in relation to the party who submits an IDE application to FDA for SR study?
As this is from FDA website and not a CFR, is this really a requirement?
3. US office can be PO box only?
The US office, if required, does not need a physical presence - it can be set up as a PO box?
If just a PO box, how does the US office act as sponsor? The contracts, insurance, finance, personnel, TMF etc. can all be agreed and held by the EU office?
4. EU office can ship directly to US sites?
If there is no US office, the investigational devices are shipped directly to the sites. Do the sites assume the role of the importer and therefore, agent & sponsor as by FDA:
"(a) Imports. In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation."
Where do these roles, relationships and responsibilities need to be documented and reported? Can a PO box assume these roles?
As this provision is taken from the General Provisions, and is not called out as being one of the provisions that must be followed for an NSR study (abbreviated IDE regulations), does this apply to NSR studies?
5. Medical/Investigational devices can be shipped to private residence?
While everyone is working from home, are there any rules around shipping medical devices/investigational devices to private residences in the US from outside/within the US?
Thanks to all in advance
