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

[TallPaul1]

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

 

[mihzago]

So to perform an EEG outside a living organism, would you cut the head off and send it to a lab for a test?

 

[TallPaul1]

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

 

[mihzago]

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.

 

[Ronen E]

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.

 

[Pads38]

And, specifically, an EEG is classified as a medical device under ProCode OMA, regulation number 21CFR882.1400

 

[TallPaul1]

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

 

[Marc]

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.

 

[TallPaul1]

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.

 

[Marc]

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...