IVD software FDA and CLIA

RegulatoryUS_EU

Starting to get Involved
#1
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?

Thanks!
 
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ECHO

Involved In Discussions
#2
If you are just taking data from a sequencer and analyzing it, I would think Medical Device.

I think K192073 is similarly analyzing raw sequencing data to make determinations.

Thus, do we need to certify a lab under CLIA requirements to perform this procedures?
Depending on where you lab is located, Yes.
 

RegulatoryUS_EU

Starting to get Involved
#3
Hi ECHO, thank you very much!

The lab is located in the US, thus, I assume a CLIA certification is needed right? in order to speed up the process, it is possible that a third-party lab (familiarized with NGS) procedures recieves the CLIA certification to conduct our procedures? instead of us having to finalize all the lab set up and qualify for CLIA
 
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