IVD Software FDA/CLIA doubts

[RegulatoryUS_EU]

Hi all,

we are developing a Software (SW) able to interpret raw data coming from next generation sequencing. The SW is able to diagose diseases. In europe, we we would classify the SW as a IVD Medical Device Software (MDSW) regualted under the IVDR

In the FDA will this SW be classified as an IVD or a MD?

Also, in order to obtain the raw data form NGS, blood samples need to be collected and processed. Thus, do we need to certify a lab under CLIA requirements to perform this procedures?

pd: we've also added this message in another forum thread in case this is not the adequate thread

Thanks!

 

[ECHO]

Linking my answer in the other forum so other can find it more easily.

IVD software FDA and CLIA