Clinical Testing - NSR Device

J

Jennifer27

#1
Dear Experts,

My company located in the United States is making two kinds of devices:

1. Tonometer
2. Blood Glucose monitoring device

We are planning to submit 510k applications. To support the indications for which we want clearance, we have decided to do clinical trials.

My questions are:

1. Since these devices are NSR (No significant risk) devices, I believe we would need only IRB approval and not FDA approval for the commencement of the study, is that right? Is there some way to bypass IRB approval, or is it mandatory before initiating any human clinical trial in the US?

2. Can we outsource our clinical testing to India. Will FDA accept clinical test data from outside the US to support applications inside of US. If we comply with all FDA regulations to execute the testing in India, will they accept it to support marketing application in the US.

Kindly advise. I look forward to your expert opinions,

Thanks so much!
 
Elsmar Forum Sponsor

davishont02

Starting to get Involved
#3
Hi Jennifer,

I would suggest looking at the following documents: ( I tried to include links but I haven't posted enough to earn the privilege. If you paste the titles in google or the FDA search engine, they pop right up. Sorry.)

1. Info Sheet Guidance for IRBs, Clinical Investigators, and Sponsors Significant risk and Non Significant Risk Devices

I don't see a way around the IRB if you are not going through the FDA. This document outlines the abbreviated IDE requirements for NSR devices and directs you to 21 CFR 812.2 (b) and (c).

2. Information Sheet Guidance for IRBS, Clinical Investigators, and Sponsors
This document summarizes a little of all documents to outline SR, NSR, and Exempt study requirements.

3. 21 CFR 56
This part is entirely about IRBs section 103 to 105 might be of interest to you

Whether the FDA will accept foreign clinical data depends. The Acceptance of Foreign Clinical Studies Info Sheet references all the docs related to this.

Hope this helps Jennifer!
 
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