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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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Some Related Topic Tags
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 #9  
Old 3rd August 2017, 12:26 PM
TallPaul1

 
 
Total Posts: 5
I am just getting into the EEG arena, but the technology is pretty incredible.

The company that I work for has developed some software that allows for real-time results with all of the "noise" filtered out. I can't imagine how difficult it must have been in the "ink on paper days"! Times are a changing.

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  Post Number #10  
Old 3rd August 2017, 12:50 PM
Marc's Avatar
Marc

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

Yup - Lots of paper. Storage was a problem. The electronics back then were quite primitive compared to today. Then again, all the machines (these days called devices, I'm sure) are are amplifiers.

I did EEGs from when I graduated high school in 1969 to 1974 when I wised up (actually my younger sister sort of knocked me up side of the head a few times and finally convinced me to) and went to college. Biology major with chemistry and anthropology minors. And I ended up in quality assurance...
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  Post Number #11  
Old 4th August 2017, 02:05 PM
TallPaul1

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

So, now that we've established that an EEG device is not an IVD, is there a regulatory path for an RUO medical device in the US that does not utilize the IDE regs? Could a class II EEG device be used as a research device without 510k clearance? If so, can this go on indefinitely or is there an expectation that it eventually gets submitted to the FDA?
  Post Number #12  
Old 4th August 2017, 08:35 PM
Ronen E

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

Quote:
In Reply to Parent Post by TallPaul1 View Post

So, now that we've established that an EEG device is not an IVD, is there a regulatory path for an RUO medical device in the US that does not utilize the IDE regs?
No.

Quote:
In Reply to Parent Post by TallPaul1 View Post

Could a class II EEG device be used as a research device without 510k clearance?
The answer for a device under ProCode OMA is NO (unless you go the IDE path).
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #13  
Old 10th August 2017, 12:33 PM
Pads38

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

In the back of my mind I seem to recall that there was an FDA guidance document that had a partial regulatory exemption for devices used under an IDE.

IIRC the exemption was for "physiological signal amplifiers".

If anyone can point me to this guidance, please do!
It could be useful.

Disclaimer:
This is digging deep in my very flawed memory banks - I may have this totally wrong!
  Post Number #14  
Old 11th August 2017, 04:56 PM
mihzago

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

so, while you have to comply with IDE requirements, it does not necessarily require submission to the FDA. If you determine your EEG device to be a non-significant risk device, then all you need is an IRB approval to comply with IDE requirements (i.e. no FDA IDE submission).

I think there are other product codes too for EEGs, depending on the use and application. Other ones I found quickly is GWS or OLV
  Post Number #15  
Old 15th August 2017, 08:15 AM
mihzago

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

I just came across a table on the FDA website that lists various product codes for 21 CFR 882.1400. Hope this is useful.

https://www.fda.gov/downloads/Medica.../UCM289350.pdf
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