Re: Pre-clinical Animal Studies
Thank you for the replies.
Ronen,
Does that mean it is all risk based? So if the device is not a new device and does not have novel features, I can go straight to human-clinical tests and skip the animal tests (given that tests have been done on similar existing devices)?
We are looking at both the FDA and EC requirements on class III transient invasive devices.
Sam,
Thank you for the document. It will come in handy when we start structuring the tests. The problem now is whether or not we need to do them.
Hi,
have a look at ISO 10993-1, which is harmonized in Europe and a recognised consensus standard in the US. Yes, you have to follow a risk-based approach.
Follow the flow chart in ISO 10993-1 and have a look at the tests-to-consider matrix in the annex of the standard.
In addition have a look at this FDA draft guidance, which highlights the Agency's expectations when interpreting ISO 10993-1:
"Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", April 2013
This draft guidance contains a slightly modified flow chart.
Generally,
1) Only test what you do not know
2) Prefer in-vitro over in-vivo testing if there is an adequate and valid in-vitro test available
3) If you can demonstrate device safety and performance in an appropriate in-vivo study of course you would not skip these animals tests and put humans on risk; at least in Europe you would a hard time with the Ethics Committee justifying a clinical study when the same data could be generated in an animal study or even in an in-vitro test ....
HTH,
Gerhard