[KSagal]

Originally Posted by [email protected]

Karl:

I think you are correct - it's not the FDA - it's the standards. I was told about this by a senior person at the VA responsible for wheelchairs. When I went looking for the standards I found this,

http://www.resna.org/sites/default/f...0140418rev.pdf

The standard costs $900... I didn't download it. What I was told is that a medical device requires at least three wheels, and if you can't stand up in the device, i.e., if you are restricted to a sitting position, that does meet the FDA definition of a wheelchair, at which point the Standard is applied to you.

The FDA rule is simple.


[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR890.3860]
See Related Information on Powered wheelchair. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart D--Physical Medicine Prosthetic Devices

Sec. 890.3860 Powered wheelchair.
(a) Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

(b) Classification. Class II (performance standards).

So, as long as you don't claim any medical purpose for the device you can market it, but, since the market is folks with a medical need, you get stuck... I got cautioned by an FDA official for using the phrase "Freedom to Move". He thought it was too close to the line...

Bottom line, that's why we abandoned the SegSurrey and focused on the SegSaddle.

Final note, the SegSaddle is currently out of production, but, we've signed an agreement with a manufacturer with good global distribution and we hope it will be back in the market in 2015.

Brian,

I thank you for your candor, and your information. I wish you luck with your business, and your devices.

I must also add however, that I have been told incorrect data many times from government employees who did not actually understand what they were talking about, but did not know that they did not know what they were talking about. Even once informed they were wrong, it did not matter to them, as they were not used to, nor willing to document what they said.

VA officials are government employees. FDA rules are administered by government employees. These rules, if they actually exist, may be germane when dealing with these two agencies, but that is a far cry from making them universal or binding...

You know best what to do with your company, your time and your battles. I would not attempt to say otherwise. Whatever certification process you decide to embark upon or not is your own choice. I wish you luck with this as well.