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Is an EEG (Electroencephalogram) an IVD or a Medical Device?
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Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
Is an EEG (Electroencephalogram) an IVD or a Medical Device?
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Is an EEG (Electroencephalogram) an IVD or a Medical Device?


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21 cfr part 882 - neurological devices, ivd (in vitro diagnostic) devices and reagens, medical devices, research use only (ruo) device or software
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  Post Number #1  
Old 2nd August 2017, 11:12 AM
TallPaul1

 
 
Total Posts: 5
Question Is an EEG (Electroencephalogram) an IVD or a Medical Device?

This seems like it should be a fairly simple question, but I can't find a clear answer! Is an EEG an IVD? I realize that in general in vitro means in a test tube, petri dish, etc, but the full definition includes "elsewhere outside of a living organism." Taking that into consideration, wouldn't pretty much all diagnostic equipment qualify as an IVD?

Thanks in advance for any insight!

Paul

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  Post Number #2  
Old 2nd August 2017, 01:18 PM
mihzago

 
 
Total Posts: 140
re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

So to perform an EEG outside a living organism, would you cut the head off and send it to a lab for a test?
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  Post Number #3  
Old 2nd August 2017, 01:27 PM
TallPaul1

 
 
Total Posts: 5
re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

Wow, I thought we were a little more professional than that. However, brain waves are received and measured using cutaneous electrodes. If you aren't familiar with that term it means that the electrodes are on the outside of your skin getting back to the definition of in vitro that includes "elsewhere outside of a living organism".

Paul
  Post Number #4  
Old 2nd August 2017, 01:32 PM
mihzago

 
 
Total Posts: 140
re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

relax, I was just making a joke, sorry if it didn't come across that way. If you're too serious in this job, you'll die of heart attack at age 45.

Your cutaneous electrodes are still connected to a living organism (I know, stratum corneum are dead, but still), and performing a measurement on a living organism.
  Post Number #5  
Old 2nd August 2017, 07:15 PM
Ronen E

 
 
Total Posts: 3,379
re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

In general, IVD means that a specimen is taken from the body and then diagnosed. I'm not aware of any specimen being taken away in EEG, however it's not my speciality.

More specifically, I noticed that you posted in the US medical devices regulations forum, so I'm assuming that you are interested in the FDA classification. In that system devices are considered IVD if they fall under one of the IVD devices classification regulations. I haven't checked but I'm guessing that EEG devices are not there.

Last edited by Ronen E; 2nd August 2017 at 07:37 PM.
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #6  
Old 3rd August 2017, 04:18 AM
Pads38

 
 
Total Posts: 694
re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

And, specifically, an EEG is classified as a medical device under ProCode OMA, regulation number 21CFR882.1400
Thank You to Pads38 for your informative Post and/or Attachment!
  Post Number #7  
Old 3rd August 2017, 11:43 AM
TallPaul1

 
 
Total Posts: 5
Re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

Mihzago, Ronen E and Pads 38 - thank you all very much for your insight! I 100% agree with your feedback and greatly appreciate your confirmation. Our device is classified as a Neurological Diagnostic, but I didn't know if that and IVD had to be exclusive of each other. However, given everyone's feedback on the same side of things in addition to my intuition - I would say that it's pretty clear here.

Thanks again!

Paul
  Post Number #8  
Old 3rd August 2017, 11:54 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,865
Re: Is an EEG (Electroencephalogram) an IVD or a Medical Device?

Years ago I was a certified EEG technologist and worked in hospitals. Back in the ink on paper days. Brings back a lot of memories.
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