On Dec 6, 2007 8:31 AM, Hammers, Alexander
<[log in to unmask]> wrote:
> You raise a very interesting point, namely approval. I wasn't aware of
> ANY neuroimaging software being FDA approved and have some difficulty
> with the concept.
Information on the FDA approval process is available on their website
Basically anything that has something to do with clinical care for
patients and clinical decision making has to be FDA approved unless it
is being used under research protocol.
> Presumably some kind of validation is necessary - but
> how would you do that, with innumerable actual or potential
> applications? Without standard operating procedures in addition, I am
> sure any user could come up with a protocol that does not do what is
> expected, and the documentation needs seem prohibitive to me. I can see
> that e.g. stethoscopes are FDA-approved - but if you haven't been
> trained, you could not realise yours is broken, or come to completely
> wrong conclusions, even with the best stethoscope in the world.
There are a few packages for fmri acquisition that have FDA approval:
... to name the first two at hand.
Woo-Suk, Tae, why do you think you need it?
Mikolaj A. Pawlak, MD PhD
Neuroradiology Research Division
Department of Radiology
University of Pennsylvania
3600 Market Street Suite 370
Philadelphia, PA 19104
mail: [log in to unmask]