From: Grant Bright, Ph.D. (gbright_at_b...)
Date: 2001-06-06 19:22:16
Here's one biofeedback manufacturer who was sued and it was a crusher, put them out of business, circa 1992
Innerquest
Little Rock, AK
It does happen!
My non-attorney, but educated "way to go" would be:
Make a kit, not an assembled product, provide well worded, lengthy disclaimer that device is for recreation only, not a substitute for medical advice/treatment, no claims made about performance, Extensive warnings about contra-indications, etc, etc.
No warranty express or implied as to use, performance, suitability, etc.,etc.,
To receive an FDA certification would take a certified lab review to prove device doesn't cause harm and how the device works, plus a controlled studyset up and approved by the FDA for the purpose of establishing efficacy ofthe device, plus about 2 years for the paperwork to grind through the FDA after all is submitted. My guess money wise, is about 250,000 to 350,000USDto accomplish this, once all design parameters are completed.
I have been very close to a device going through this process, and it is a difficult and time consuming process...still going on after three years. I know of another device that has been in this process for over five years and it is not approved yet, either.
The FDA has a publication about doing this, patterned from the Lexicor Medical Technology pursuit of FDA acceptance. It took several years, and hundreds of thousands of dollars because Lexicor was first cited by the FDA, and then began working on FDA acceptance. Even though their start with the FDA was not good, the process they followed after the citation was valid. It isall in print--and thick.
But this is not to say it can't be done, a willing lab doing work pro bono,and a well known/versed researcher working pro bono could achieve acceptance...it can be accomplished, it just is not easy, or everyone would have "FDA accepted" devices.
Best wishes to the effort,
Grant
----- Original Message -----
From: Rob Kall
To: INTERNET:buildcheapeeg_at_yahoogroups.com
Sent: Monday, June 04, 2001 9:52 PM
Subject: [buildcheapeeg] a little more rain on the parade
I've never heard of a single case of litigation against a biofeedback
manufacturer or vendor, not one.
Rob Kall
Futurehealth, Inc.
211 N. Sycamore St., Newtown, PA 18940 215-504-1700, fax 215-860-5374
www.futurehealth.org
10th annual Winter Brain Meeting February 7-11, Miami Florida
"We're much more like flickering flames than hunks of meat."
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This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:30 BST