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On going Stability for IVDs
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On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
On going Stability for IVDs
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ivd (in vitro diagnostic) devices and reagens, post market activities (misc)
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  Post Number #1  
Old 14th March 2018, 01:27 PM
ernieto's Avatar
ernieto

 
 
Total Posts: 14
Question On going Stability for IVDs

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

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  Post Number #2  
Old 12th April 2018, 09:48 AM
ernieto's Avatar
ernieto

 
 
Total Posts: 14
Re: On going Stability for IVDs

Any help will be appreciated. thanks.
  Post Number #3  
Old 15th April 2018, 09:31 PM
QAengineer13

 
 
Total Posts: 142
Re: On going Stability for IVDs

Quote:
In Reply to Parent Post by ernieto View Post

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
Thanks to QAengineer13 for your informative Post and/or Attachment!
  Post Number #4  
Old 16th April 2018, 08:35 AM
ernieto's Avatar
ernieto

 
 
Total Posts: 14
Re: On going Stability for IVDs

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?
  Post Number #5  
Old 17th April 2018, 06:20 AM
invitro_spain's Avatar
invitro_spain

 
 
Total Posts: 70
Re: On going Stability for IVDs

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.
Thanks to invitro_spain for your informative Post and/or Attachment!
  Post Number #6  
Old 17th April 2018, 06:48 PM
QAengineer13

 
 
Total Posts: 142
Re: On going Stability for IVDs

Quote:
In Reply to Parent Post by ernieto View Post

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.
Thanks to QAengineer13 for your informative Post and/or Attachment!
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