On going Stability for IVDs

[ernieto]

Don't know if this is the right forum.

Is there any requirement for ongoing or post-approval stability for IVDs? Looking for what is the requirement through FDA and EU? Thanks

 

[ernieto]

Any help will be appreciated. thanks.

 

[QAengineer13]

Don't know if this is the right forum.

Is there any requirement for ongoing or post-approval stability for IVDs? Looking for what is the requirement through FDA and EU? Thanks

Hi Ernieto,

My 2c's from my experience working with IVD this is a standard which discuss in detail about the Stability of IVD Reagents https://clsi.org/media/1424/ep25a_sample.pdf

 

[ernieto]

Thanks for the reply. I have that document and I also use ISO 23640:2011 In vitro diagnostic medical devices: Evaluation of stability. Do you now where FDA or EU mentions that is required?

 

[invitro_spain]

Hi Ernieto,

I think the best standard for the US is the CLSI EP25a as QAengineer said. In any case, the relationship between the CLSI and the European Harmonized standards is acceptable.

 

[QAengineer13]

Thanks for the reply. I have that document and I also use ISO 23640:2011 In vitro diagnostic medical devices: Evaluation of stability. Do you now where FDA or EU mentions that is required?

Its an implied requirement from the FDA /EU or any regulatory agency because the Requirement for PERFORMANCE OF SAFE & EFFECTIVE medical device/IVD is part of the essential requirements, so I would say the stability is one of the key requirements that could be used to strengthen your performance claims of the marketed device.