J

Jennifer27

#1
Dear Experts,

We are a medical device company that creates a wide variety of device. Currently, we are working on a blood glucose meter which is an IVD.

We are going to perform bench testing of our meter to verify the meter's repeatability, reproducibility, accuracy etc. This testing will be submitted to the FDA.

To obtain blood samples for testing, we have two options:

1. We collaborate with hospitals who will provide us with blood samples of diabetic and hypoglycaemic patients.
2. We create our own diabetic and hypoglycaemic samples, by adding some amount of glucose in blood taken from us.

I have two questions:
1. Which of the above you think is a better way to go about testing?
2. If we decide to take blood samples from the hospital, then do we need to comply with GCP, do we need to get informed consent forms, and get IRB approval of protocols?
We consider this as bench testing and not clinical testing, but what are your thoughts, should we comply with GCP?

Thank you so much!
Eagerly waiting for your response,
Regards,
Jen:thanks:
 
M

mogluk

#2
yes to use actual blood samples, you will need to comply with IRB requirements. And you should be conforming to GCP and cGMP for your product.

use of artificial samples can be used. Be prepared for greater scrutiny on your samples and their preparation (3rd party verification sample contents).
 
J

Jennifer27

#3
Thank you Mogluk! Yes you are right if we do artificial samples then yes more scrutiny from the FDA. Thanks a lot for your help.
 

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