FDA help

[David C]

My cat would be a medical device if I said if he sat on your lap he would cure depression. Besides the fact that he does.

 

The way the laws and definitions are setup almost anything can be classified as a medical device if you make claims about it. And in this case, from what they said, and how it works, it meets the legal definition of a medical device. Oh joy, here cometh the FDA. It's kind of a wierd concept & hard to grok initially but how else would you define a medical device? You can't go by what it is, or made of, or designed, as the range is too broad and constantly changing. So they went with what it does and how it does it (not chemical). And who defines what it does? The person or company that manufactures or markets it. So people/companies making claims just made themselves the bullseye.

 

Normally if someone is crossing the line, they go after just that company. In this case it sounds as if it is pervasive enough that they are moving against the whole industry.

 

As far as the FDA is concerned, annecdotal evidence and $3.91 wil get you a grande mocha at my local starbucks. A well designed clinical trial is what counts to them and to most of the scientific community. But the trial is not to establish whether something is a medical device, but whether it is safe and effective.

 

The problem is, those cost lots of moola and more fun times with the FDA or an Institutional Review Board getting the trial approved. And unless someone can get market control and make a pile of dough, no one will front the money.

 

If it works for someone and there's no harm then to me there's no foul. If it had stayed low key, it probably wouldn't have elevated it to the FDA's attention and now you are in legal limbo land. I wish you luck.

 

Class III - that doesn't make any sense as that is for critical devices such as implantable pacemakers or defibrillators. More likely Class I as that is for fairly innocuous devices and yes you can get some medical devices without a prescription. An example of a fairly complex device anyone off the street can buy - an Automatic External Defibrillator (AED).

 

Non-disclaimer: If you haven't guessed, I'm in Regulatory Affairs and have worked for several medical device companies and my primary responsibility is getting FDA clearance to market our devices. And I worked for the FDA for a while doing inspections. So I know the boat you are in. Sometimes the agency can be reasonable, sometimes not. It depends on the current political climate, for what the FDA has been hammered on for lately, and who you are talking with.

 

Side note: L-tryptophan was banned initially as there were deaths linked to it and they didn't know why. It was determined that a manufacturer changed to a new genetically altered bug to produce the stuff and a dimer form of it was found in small amounts and it was what was causing the problem. AFAIK, none of the other companies had this problem. I don't fault the FDA for pulling it initially, but they should have lifted the ban and required manufacturers to test for this contaminent if they changed to a different strain of bug to produce this amino acid. Problem solved and prevented if the rules were followed. But it stayed on FDA's shelf for some reason - I don't know why.

 

Shoot me a PM if you want some advice, be warned however, my fees are quite stout - a ride if I'm ever in your neighborhood :-)

Edited April 5, 2010 by David C

[7evin]

David,

 

You hit the nail on the head....

As you are well a where of it can be a serious up hill battle.

If they choose to they can make you life rather difficult.

 

Thanks for the info I will PM you.

[David C]

Perused the FDA website. Looks like they brought a howitzer to a checkers match. Will PM you

[slngsht]

my fees are quite stout - a ride if I'm ever in your neighborhood :-)

 

I don't know if I'm man enough to ride with Kevin

[MHKflyer52]

I don't know if I'm man enough to ride with Kevin

 

I am with slingsht on that as I do belive Kevin is the fastest sevener in the USA especially in the rain on a wet track and I will bet he really knows his neighbor hood.

[David C]

http://sportsillustrated.cnn.com/inside_game/magazine/life_of_reilly/news/1999/09/14/life_of_reilly/

Kevin would be driving :driving: and I would be :puke:

[MHKflyer52]

Kevin would be driving :driving: and I would be :puke:

 

Yep "Two Bags" but not upside down. :smilielol5:

[Mondo]

As a passenger, I got the pleasure of a short trip thru the gears in Kevin's car. I didn't put on the seatbelt as his wife is quite a bit smaller than me and it was going to be a short ride (though I noticed Kevin put his on... probably out of habit).

With the new slicks I swore the front tires were going to come off the ground as the rear tires struggled for grip... he quickly went thru the gears; shifted from 4th to 5th in about the same time he did first to second! I think it was faster than my sportbike in the 50 to 100 range! All I could think of was how far I'd fly if he lost control.

Scared the heck out of me.....

 

 

 

 

but after a while I wanted to feel that speed again;)

[s2k7]

xxx

Edited January 24, 2014 by s2k7

[7evin]

Thanks Guys, We really appreciate all the kind words and support.

 

We filed an injunction against them on Friday.

So we will see where this goes.

 

It is really cool to be part of a group that can do more that just think

outside the box..... For years I did not even know about this thing call the Box,

let alone that I was not supposed to think out side of it...

 

I guess that is why we drive sevens.... No boxes....

 

Thanks again...

 

I'll update this thread on occasion to let you know how it is going.

[David C]

At your next meeting with them, tell them you've decided to rename your product in their honor: Rear Candles. :jester:

[Jim F.]

Lighted end in or out?

[7evin]

Thats a good one....

My Wife wanted to rename them "FDA Rebellion Torches"....

Then if they asked us why anyone would buy them?....

We could look at them say,

We just don't know....

 

(FDA) What is there intended use?

 

To... Light the way...

[David C]

Thay way you could blow smoke up their........

 

Well I guess you could do lighted end in, the intended use would be FDA Hemorrhoidectomy cauterization candles.

[7evin]

I like the way you think !

[7evin]

We filed an injunction against the FDA today..... :~) I'm sure that will make them Happy.

 

Thought we should do it to them before they do it to us.... Better to be Offensive than Defensive...

 

It only cost as much as a new Catherham to get started....

Yea.... just to get started..... Kind of makes you sick to think of all the resources it takes

just to try and stay in business and fight my own government to be free...

 

And we wonder why American manufactures are moving out and taking jobs.....

 

We are going after the FDA on several counts of constitutional violations.

Not that they or the courts even know what that is anymore.

Even though they take an oath to support it...