From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2001-12-07 05:54:08
Joerg Hansmann wrote:
> I have absolutely no idea if the current modularEEG
> isolation voltage is sufficient to get e.g. a FDA
> approval.
Here's a lead on FDA EEG regulation ... EEGs are
listed under 882.1400 through 882.1430
http://www.fda.gov/cdrh/devadvice/part882.html
I have't looked at the actual regulations ... here
are some other FDA things related to EEG ...
The Food and Drug Administration (FDA) regulates the
sale of any products for which medical claims are made.
NeuroSonics does not believe that FDA approval is
required with respect to distribution and sale of products
because they utilize the MCC™ technology or the BGM™
technology to evoke the relaxation response.
http://www.neurosonics.com/tech.html
FDA Enforcement Report ...
Product: QSI 9000 EEG Normative Data Base for Analyzing
EEG (electroencephalogram) records.
Reason: The device was marketed without required premarket
approval authorization. Firm is revising labeling to
indicate that the device should not be used for diagnosing
clinical conditions such as Tumor, Schizophrenia,
Alzheimer's Disease, Head Injury or Obsessive-Compulsive
Disorders and that the data base should not be used as a
sole means of analyzing EEG records.
http://www.fda.gov/bbs/topics/ENFORCE/ENF00056.html
February 14, 2001 -- Cleveland Medical Devices Inc., one
of Ohio's fastest growing technology companies, today
announced FDA clearance for its Crystal-EEG (R) Model 15.
The wireless monitor records Electroencephalogram (EEG)
signals without physically connecting patients to bulky
diagnostic equipment. "We're delighted that we have
received market clearance from the FDA," says Robert N.
Schmidt, president of Cleveland Medical Devices.
http://www.clevemed.com/about/fda.html
FDA recently approved the SynAmps . EEG amplifier and
Curry ® multi-modal neuroimaging software for clinical
use. As a part of that approval,the FDA also approved the
use of certain accessory devices and software programs.
The following products from Neuroscan Labs are now FDA
approved for clinical applications. This new development
will allow researchers to fulfill their demand for
equipment that can be used in both clinical and research
settings.
http://www.neuro.com/neuroscan/news.htm
April 25, 2000--The Grass-Telefactor Product Group of
Astro-Med, Inc. announced today that they have received
FDA clearance to market and sell their new, miniaturized
amplifier system for long-term epilepsy and EEG monitoring.
The FDA clearance covers all intended uses for the
amplifiers, including routine EEG, long-term EEG and
epilepsy monitoring, and overnight sleep recording.
http://www.astro-med.com/newsfdaclear.html
It *sounds* like you need FDA approval to claim any kind
of medical usage. What is unclear to me is whether you
need FDA approval for clinical use of the EEG, and further
if that *excludes* you from selling to the public. It is
interesting how the Brainmaster FDA approval is only for
"relaxation training using alpha waves"; clearly there
are people using them for ADD/ADHD and other treatments.
Also interesting how Brainmaster used to sell to public,
but now they seem to only sell to practitioners or to
the public only with written permission of a pracitioner.
What does all of this mean? I have no idea :(
-- Doug
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:33 BST