Regulatory Open Forum

Dear the RAPS community,

Our company has developed an IVD product that uses RT-qPCR method for cancer diagnosis. This product has been validated on a number of PCR platforms, each platfoms has its own cut-off value. However, due to updates of PCR platforms and PCR softwares, there are increasingly more requests from our customers to validate our PCR kit on a newer version of the previously validated PCR platforms or PCR software. We have done validations including analytical performance and clinical performance of several platforms so far. 

My question is when there is an update of the same instrument,  to what extent we should perform the validation to make sure it is compatible with our kit and can include this newer instrument in our IFU.  Are there any regulations from or examples that I can learn from it?    How about software updates of the validated PCR instrument, what kind of validations we need to do?  Thanks.

Susan

Hello Susan,

Your question can not really be answered in a forum post because it is quite involved and would be very specific to the IVD product and the PCR platforms being used.  In fact, when developing a PCR test which can be used across many different platforms has this configuration management challenge which sometimes can be untenable.  The greater number of PCR platforms and software versions which are available, can cause validation activities to exponentially increase.  This level of detail you will not find in a regulation either, taking experience and understanding of validation processes to implement a proper programme.  The extent or amount of validation depends on what your kit is being used for, already cancer diagnosis you are looking at high-levels of testing since this would be considered a high-risk device.  It also depends on the PCR platform being used, the processes involved, and what changes to the software are being made.

Dear the RAPS community,

Our company has developed an IVD product that uses RT-qPCR method for cancer diagnosis. This product has been validated on a number of PCR platforms, each platfoms has its own cut-off value. However, due to updates of PCR platforms and PCR softwares, there are increasingly more requests from our customers to validate our PCR kit on a newer version of the previously validated PCR platforms or PCR software. We have done validations including analytical performance and clinical performance of several platforms so far. 

My question is when there is an update of the same instrument,  to what extent we should perform the validation to make sure it is compatible with our kit and can include this newer instrument in our IFU.  Are there any regulations from or examples that I can learn from it?    How about software updates of the validated PCR instrument, what kind of validations we need to do?  Thanks.

Susan