A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements

[SANE]

Dear all, I hope you can help me.
There are documentations describing the requirements in respect to studies needed to collect data for a FDA submission. Usually drugs or a medical devices are described there as the product for investigational use.

Now we want to perform a non interventional pivotal study (just pivotal observational study) with an IVD laboratory diagnostic product labelled as product for investigational use only. We have several study sites (clinical centres) in Germany, one site in US will complete the German ones.

We have got different feedbacks related to the need of a "Clinical Monitor" for our study project. In general it is clear that a Clinical Monitor is needed if the investigational product is a medical device. However, there were different opinions related to the need of a Clinical Monitor for a study if the investigational product is an IVD product used in the lab (ELISA).

I do not find any proper documentation. Can somebody tell me whether a "Clinical Monitor" is needed? Can somebody tell me where I can find relevant documentation addressing this aspect.

Many thanks in advance for your support.

 

[chris1price]

Very difficult to answer without a lot more information. When I previously filed ELISA based laboratory IVDs, we did not use a clinical monitor, but that doesn't mean the same applies to your product. Filing a Q-Sub with FDA might be the best way to get an answer.

 

[SANE]

Dear Chris1price,
thanks for the hint. Issue is that we have to decide for internal reason before going into the Q Sub. Did you use your study for FDA submission?

 

[chris1price]

Standard practice was to have blood samples collected from the appropriate demographics in the USA and have them tested at an independent lab. This was submitted to FDA as part of the 510(k)s. The only issues we saw concerned having sufficient data on the samples to ensure we met the necessary population demographics.

 

[SANE]

Standard practice was to have blood samples collected from the appropriate demographics in the USA and have them tested at an independent lab. This was submitted to FDA as part of the 510(k)s. The only issues we saw concerned having sufficient data on the samples to ensure we met the necessary population demographics.

Ok. I think this we have considered. To be on the sure side we will cross check this with FDA as well.