FDA approval

[-=Jim=-]

You could die tommorow and have a million dollars on your account and you had the chance of helping people how stupid is that. As long as i can buy a martini-bitterlemon i,m fine

I could not agree with you more here and I feel stronger about this as I get older.

Please don't under estimate the risk of doing business in the U.S. with a product that is by nature dangerous. You could build the best and safest product in the world and if the laser operator hurt someone I guarantee you would be in court along with the operator. Now I'm sure many will say if the product is safe you have nothing to worry about and the courts would side in your favor and that is probably true as long as you have several thousands of $$ put aside for attornies, airfare, lost wages, and living expenses during the trial.

I'm sure this all sounds like a small risk but I can assure you it is a possibility. I can relate to this personally, about 20 years ago I received a summons to appear in court as I was being sued by a man who was ingured in "My" Bowling Alley. Well It seemed pretty funny to me a first because I NEVER owned a bowling alley. I wasn't laughing when I had to pay my lawyer to appear in court to get the case dismissed.

In summary if you really don't care about making a profit just make enough to keep aside in case something happens out of your control.

Jim

[edison]

Thanks jim for the info. Its always nice to learn from someone thats longer in the bussiness then i,am.

I,m not planning to sell complete projectors over there. At first i only want to try to get the FDA approval
to help some PL members here. If i make some money (and i,m not talking about penny,s) I will start a small company to get a better quality of live.(learned in New Zealand) My plan is to work for 32 hours and fund the last day true the laser hobby/ bussines. Some say what about pension? My dad worked his ass of for 40 years and died at 61 so there,s your answer.

I will dive into the FDA aproval thing but now i,m busy with the groupbuy. Blowfly, ledpaint, and synce maybe we can devide tasks to get the aproval. Shoot me a pm.

[-=Jim=-]

First I hope I’m not giving the impression that I’m expert in the Laser Light Show business, in fact that is very far from reality. My experience has been with other businesses and like Jon said……

trial and error, trial and error, then - trial and better...

I just never reached the better. Looking back at my mistakes I see that you can never win by under pricing your services or trying to make something or sell a service cheaper than the other guy. All you do is drive your own market down and you will get tired of working for free or losing money.

Now Again… take my advice with a grain of salt. I’m too old to fix my mistakes but I see some of the brightest people in the field including yourself and don’t want you to go down the same road I have.

Now go and make a Better Case and not a Cheaper Case

[buffo]

Electrofreak asked about a "checklist" for cases... Unfortunately, such a list doesn't exist - at least not that I'm aware of anyway. Your only option (apart from hiring a company like Laser Compliance Inc to do it for you) is to read through 21CFR1040.10 and .11 until you finally figure out what it is that they want. It also helps to read through the "guide to filling out a laser product report". And as Marc has mentioned before, once you've filled out a few product reports, you sort of get the hang of it. But the first one is always going to be a bitch. (Which is why mine is sitting on my desk at home, only 1/3 complete...)

Adam

[gottaluvlasers]

Hey Guys-

Download THIS.

This has pretty much everything you are going to need.

I also attached a form that i dont think i had in that CDRH folder.

FDA form 2877 for importing.

-Marc

[ElektroFreak]

Thanks for that link! I found that awhile back and downloaded it, and now I'm attempting to decipher it all. It will be awhile before I feel like I've finally figured it out.. but I will eventually.

My plan is to document each step of the certification process and then create a thread here where it is broken down in the simplest terms possible so that others can get an idea of what is required WITHOUT having to hire a consultant or an attorney to decipher the legalese. There should be clear, concise instructions on how to become legal. With the current "structure" of companies maintaining artificially inflated pricing to "restrict" the number of companies legally allowed to produce shows combined with a set of very difficult to follow CDRH paperwork, a black market has been established (very predictable in situations like this) and it is thriving. Said black market could be reduced considerably by simply making the process of becoming legal more easily understood. I'm NOT talking about reducing the amount of paperwork, rather I'm talking about creating a guide to building safe, certifiable systems and filling out the paperwork, with explanations of the more obscure terminology and explanations that clarify references to other legal texts. I'm also NOT talking about building cheap, flimsy systems. I AM talking about listing the requirements for certification so that others can easily see what is required, and then either buy or build depending on their budget and tastes.

[MisterWilling]

My plan is to document each step of the certification process and then create a thread here where it is broken down in the simplest terms possible so that others can get an idea of what is required WITHOUT having to hire a consultant or an attorney to decipher the legalese.

This comes at a good time for me, I will be building my enclosure over spring break. I'm going to a similar design as the LT-1000.
If it is anything like your soundcard DAC tutorial I am looking forward to seeing this in the future. Thanks.

[ElektroFreak]

It is going to be a non-trivial task that will take some time.. the documentation can be difficult to follow from what I've seen so far. Awhile back I created a thread called "the variance thread" which I will be bumping whenever I make some headway.. Hopefully you and many others find it helpful when it's done.

[Synce]

.. Hopefully you and many others find it helpful when it's done.

I know I will!

I know one thing that would help me would be a "documentation hierarchy" illustrating how all the documents are related etc.

[norty303]

I don't know how you stand 'that side' of the pond, but over here we have a requirement of government organisations to publish their paperwork in language that is able to be understood plainly, without overly exotic words, or 'Plain English' (I realise you folks over there will struggle a bit there for a start y'all )
I'm guessing from what you've written this it probably isn't the case, but it might be something to try to aim for if the relevant authorities are wanting to take note - however from what I gather of your legal structure, a lot of this stuff is set up purely to keep the lawyers in gainful employment - and seems to be doing the trick!
I also find it quite loathesome and despicable.