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FDA Compliant importers

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flecom

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want to do a party (for pay)...I can now apply for the variance for this one event...correct? As long as the unit is in compliance, I shouldn't have a problem.
that is not how it works, in order to fill out a show report you need the variance # for your projector... if you have not gotten it yet you cannot do a show

three separate things...

product report
variance application
show report
 



qumefox

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Though none of those have anything to do with the FDA accession process.. Though having a projector that has an accession number will help with the product report part a bit I think. It's entirely possible to do it without an accession number for DIY display devices though, since the accession number requirement is just for devices 'entered into commerce in the USA'.. i.e. Sold. If you have a DIY projector you built and use yourself, you don't really need an accession number unless you plan to sell it.

The afore mentioned product report, variance, and show report are what ensures all safety conditions are met regarding the devices use.
 
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KGB_Productions

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4 steps to be compliant

1) Variance app
Fill out and submit...less than 8 page report, they will send you an ascension number witch is only a case file number, its meaningless for anything else and is not confirmation of approval or permission to start doing shows.

2) Product report
20+ pages of basically describing every aspect of your projector, you submit this along with your variance app..

3) Variance approval
you cannot legally do a show without variance approval, this takes MONTHS maybe even YEARS to get back from the CDRH..
I started the variance process for my most recent lasers before I even began building them.

4) Show report
You would fill this out prior to any show but AFTER you already have your variance number.... this basically describes your projector/stage setup..
 
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ElektroFreak

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Also, you do need to obtain accession numbers for DIY projectors, since the CDRH views the act of using the projector to do paid shows as "entering it into commerce". In my experience so far, however, it's not hard to get accession numbers for DIY projectors as long as the 5 key requirements are met:

1) Correct labeling on the projector housing and at the aperture, detailing the hazard level present. Basically a standard "laser warning" label will work, but it needs to include wavelengths and total max power output. There should also be a warning to avoid exposure.

2) A case interlock that kills power to all laser systems when the case is open (unless bypassed by a qualified operator for maintenance).

3) A keylock switch to prevent activation of the laser unless the key is present.

4) A shutter or instant kill switch to prevent output in the event of an emergency or other safety system failure.

5) A front panel emission indicator light, consisting of an LED or other lamp on the front of the projector near the aperture. This serves as a warning that laser emission is occurring or about to occur.

So far in my experience these requirements are all you need to cover. Other than that your projector could be made of jello and whipped cream. For the longest time I was convinced that a person needed to buy "pre-varianced" cases, parts etc, but that, it turns out, is a total crock. Using projector cases that already incorporate the necessary features and have been granted accession numbers is HUGELY convenient, but if a person is patient and thorough in ensuring the requirements are met, and descriptive when submitting their product report then ANY projector design can be granted an accession number. Hence X-Laser.

Here's a few more good resources: U.S. regulations - Laser Compliance®

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095304.pdf

Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)
 
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hakzaw1

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^^^ IS THAT ALL?? I thought it was a lot of work--lol
 

flecom

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Also, you do need to obtain accession numbers for DIY projectors, since the CDRH views the act of using the projector to do paid shows as "entering it into commerce". In my experience so far, however, it's not hard to get accession numbers for DIY projectors as long as the 5 key requirements are met:

1) Correct labeling on the projector housing and at the aperture, detailing the hazard level present. Basically a standard "laser warning" label will work, but it needs to include wavelengths and total max power output. There should also be a warning to avoid exposure.

2) A case interlock that kills power to all laser systems when the case is open (unless bypassed by a qualified operator for maintenance).

3) A keylock switch to prevent activation of the laser unless the key is present.

4) A shutter or instant kill switch to prevent output in the event of an emergency or other safety system failure.

5) A front panel emission indicator light, consisting of an LED or other lamp on the front of the projector near the aperture. This serves as a warning that laser emission is occurring or about to occur.

So far in my experience these requirements are all you need to cover. Other than that your projector could be made of jello and whipped cream. For the longest time I was convinced that a person needed to buy "pre-varianced" cases, parts etc, but that, it turns out, is a total crock. Using projector cases that already incorporate the necessary features and have been granted accession numbers is HUGELY convenient, but if a person is patient and thorough in ensuring the requirements are met, and descriptive when submitting their product report then ANY projector design can be granted an accession number. Hence X-Laser.

Here's a few more good resources: U.S. regulations - Laser Compliance®

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095304.pdf

Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)
1) labeling requirements are very specific... not just any sticker will do

2) you can get by that by using screws that use special tools (ex torx or allen screws or something)

3) also the key must be non-removable on the armed/on position

4) mmhmm

5) there are arguments on the wording of the whole emission indicator thing... nothing really says it has to be on the front of the projector IIRC
 

Xlasers

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Hi all -

This is Dan from X-Laser... the real X-Laser.

I was directed to this thread because our products were mentioned and I need to clear up a few things. Before anything else I would suggest that anyone wanting to make sure that their civil and regulatory liability is covered turn to a professional compliance consultant who can help you with your particular situation. A good deal of the information presented here is really not correct and/or only applicable to a narrow set of parameters and so I would suggest that people seek the advice of a professional accustomed to working with FDA to make sure their bases are covered if they are concerned. That said, let me clear up a few things:

First, a caveat: I am not talking here about pointers or medical, scientific, industrial, or other categories of laser. I am only speaking of demonstration laser show projectors. There is a huge debate going on about the classification and status of pointers and I really don't want to wade into that right now, slash I want to confine my remarks to what I know best which is light show lasers.

Instead of responding directly to individual comments because that would take too long, let me just lay out the process:

Someone decides to build a laser which they intend to sell, rent, or use in a 'commercial' endeavor in the United States. Commercial being VERY generally defined as anything outside of your own home... lots of exceptions to that - so for right now I am going to focus on lasers to sell.

They build that laser, decide that they want to sell it in or into the US market, and begin the regulatory process. First, they need to create a product report detailing how the product is made, what QC processes are in place to keep the laser compliant throughout its lifetime, how it is serviced, what information is provided to the user and so forth. They then take that report and along with it file for a manufacturer's variance to make that product and sell it into the US market. They receive TWO accession numbers, both of which are meaningless as they are just file numbers in FDA database. Generally they will also apply for another variance for performance thus generating a third accession number as it is generally assumed that they will need to "manufacture" a "light show" to demonstrate their product. This third filing is not always necessary.

Because the accession numbers are meaningless this person cannot sell their projectors into the US market. What they CAN do with the accession number is - if the lasers are coming from overseas - import the units in 'reasonable quantities' into order to perform testing and R&D. That's why you can get illegal lasers through customs sometimes... However, these units do not yet have approval to enter commerce and thus cannot be legally sold and it is a Federal crime to do so.

The one person I will mention directly is EF who said something along the lines of 'any design can be granted an accession number. Hence X-laser.' Not sure what that means but every docket is given an accession number, none are "granted." Approvals are "granted" and not just for any projector design. We worked long and hard to make our base designs acceptable to CDRH and to imply otherwise is simply not accurate.

Why? If I send the FDA a product report saying that I was going to build a laser into a snowman and shoot it into the street I would get an accession number. That would be crazy and would never be approved which is why the manufacturers variance ONLY follows the approved product report. It is correct that FDA does not approve products or companies... but they DO approve or disapprove product reports and variance applications. If you do not have an APPROVED product report AND variance which specifically says that the projectors can now be "introduced into commerce," you have a laser which is not yet legal to sell, buy or use whether under a performance variance or not.

Ok - so all of your stuff is submitted. Eventually if you have done everything correctly and are not selling illegal product in the interim, you will get that letter saying that you can introduce your products into commerce. That letter will contain your manufacturer's variance number which is the ONLY number that matters. Someone with a variance can legally sell, rent, etc. Class IIIB and IV laser products. No variance = not legal and subjects you to fines up to and including $1,100.00 per use or sale with each day counting as a separate infraction to a maximum of $330,000.00.

Once approved and selling into the US market, you will need to ensure that each purchaser has an active variance in effect at the time of the sale and, as a purchaser, you need to make sure that the laser you want to buy is manufactured under a real, active manufacturers variance because otherwise using it would be a violation of the terms of your own variance.

That's it in a nutshell and thanks to Frank and KGB who both started to clear this up. I am happy to answer any questions anyone may have, about nearly anything, and so as not to be rude since this is my first post, "Hello!"

Dan
 

qumefox

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Can you direct me to the sub-clause of CFR 21 that discusses the 'manufacturers variance' requirement? I've read over it several times and your mentioning of this part is still foreign to me.
 

ElektroFreak

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Tnx for the input Dan, what I was trying to say is that it is NOT necessary to buy and use "pre-varianced" projector parts and cases. Any design can be approved as long as it meets the requirements set forth by the CDRH. That was my only point. As far as our company goes, aside from the systems we have that came from a now-defunct club here (these are already approved) we have committed to building as many of our own projection systems as possible for cost reasons. We are then able to pass even more savings on to our customers, who thank us by keeping us stocked with more gigs than we can handle (almost lol).. I believe that this is the reason why your company is able to use "non-OSLS mega-dollar" cases, and systems that are Chinese in origin. I've not bought from X-Laser, but everything I've read about your company indicates that you take (or used to take) systems that would not pass muster on their own and add the necessary features to gain approval, go through the motions of obtaining approval, and then sell them to end users. Correct me if I'm wrong of course.

My terminology was incorrect, approval is far more accurate than saying an accession number was "granted", so thanks for that correction. Fortunately we have several people involved in our company that have a good deal of experience with this stuff.. they keep us sorted quite nicely. So far we have yet to receive replies regarding our company-designed single-color projectors, but we are confident that, if the CDRH ever decides to act, we will gain approval of our product.

Also, there is SOOOOOOO much confusion regarding CDRH policy and procedure, including amongst the "experts" that I will submit that a person trying to obtain approval for DIY projectors should simply cover the basic requirements set forth by the CDRH, submit a thorough and complete product report and see what happens. The worst that can happen is that the CDRH does not give you approval, or you might pass with flying colors. The single biggest asset to have as a person seeking product approval is patience.

Personally I decided the best bet for my own future with laser shows was to link up with professionals here in my city, people who have done this before, and let them guide our efforts. So far they have done beautifully. Without the efforts of everyone involved, our company would not have gotten off the ground.

Finally, other than my misuse of terminology, I fail to see where "a good deal of the information presented here is wrong". I think you basically elaborated on what's already been said here, and provided valuable insight which is always most welcome.
 
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Xlasers

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Can you direct me to the sub-clause of CFR 21 that discusses the 'manufacturers variance' requirement? I've read over it several times and your mentioning of this part is still foreign to me.
Fox, just like there is no mention in the .10 performance standard for the users variance there is not one for the manufacturer's variance either. Part of what frustrates people about the FDA rules is that several key aspects exist primarily by implication and are seldom spelled out. You may like to read Laser Notice 55 (Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)) which discusses both variances for manufacturing products and shows. The point of the notice is to talk about renewal procedures but they clearly reference both types of variances in the and/or. In essence because the 1040 performance standard limits emitted power to IIIA/R levels, a variance is required to produce the products and introduce them into commerce as well as doing shows.
 

Xlasers

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EF,

Thanks for the thoughtful response. We don't know each other so I will take lightly your implication that my vested interest is in making things complicated so people will buy our products. I think that if you speak to people who know me well they will tell you that I take a great deal of personal pride in being an accurate and work to be an unbiased resource for the DIY community. I never post on a board like this to sell a projector... to be honest, most of the people in this community and on PL should not buy our products as they are intended for a very different kind of user. That said, I feel it is essential that everyone play on the same field using the same rules and so I work to clarify those points when I can so that, as you indicate, folks can try their hand if they wish. There is nothing wrong with that whatsoever... it is when people start making declaratory statements like 'as long as they have an accession number it is fine to buy' that I feel the need to step in and say otherwise.

The rules are complex - saying otherwise in my opinion really ignores the basic reality that the complexity results from their effort to be accurate and minimally burdensome to so many different situations. The irony in that is thick of course because it has resulted in so much confusion but I have spent many hundreds of hours working within the regulatory environment and countless thousands of dollars getting people much more experienced than I am to teach me the ins and outs... and then I try to make that information available for others.

As for what we do, you are partially correct indeed. That is one aspect of our business but it is a bit more complicated than that. X-Laser is really 20% pure manufacturing and 80% a 'system integrator' taking public domain technologies and systems, licensing proprietary technologies and developing our own technologies and then integrating them into a marketable, compliant product. In some cases we will spend a couple of months doing R&D on a chassis design working to improve it and make it compliant and then send the final design out to be made by our various suppliers with finish manufacturing and certification happening at our facility. Sometimes we purchase off-the-shelf solutions and adapt them for our particular needs and compliance standards and sometimes we make things wholly from scratch, firmware and all. It just depends.

The value we bring to the market is creatively putting smart ideas together in a way that produces a superior product and then making them in enough volume to deliver them at a good price. We will never be the cheapest... innovators never are. We will also never be the most expensive... at least as of now we don't make Ferraris. That segment of the market is well tended and not really of interest to us. We exist in the middle making solid lasers 'for everybody else' which puts us front and center with numerous unique compliance challenges and has necessitated that we develop a strong competency there. That said, we frequently look to other compliance professionals for their expertise and are always happy to share. Safer products used better is best for us all.

As CDRH has recently said, "pre-varianced" products are not currently recognized by the center so I would not think that anyone would want to purchase such things for that reason. That being the case, we are always happy to put in two cents on safety and compliance issues as people build their own components and work on their own projects. We often frequently hire such folks for individual projects or purchase good ideas from them and I am always welcoming of feedback.

Best,

Dan
 

ElektroFreak

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I always take the word of a salesman with a grain of salt. That's all I was saying by that insinuation.. normally a very safe insinuation to make. I have edited my post to reflect your apparent lack of such motives. In all honesty it's very good for LPF that you're here. You have more experience than me and most of our members with these kinds of things without a doubt. I appreciate your willingness to break things down for the community.
 

Xlasers

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That is perfectly fair and I totally understand where you are coming from. It just so happens that I hate doing sales both because I am not particularly good at it and because frankly I would rather be able to have conversations with people that are not perpetually suspect. Otherwise, it is half a waste of time and there is very little that I hate more than wasting time.

Its funny though... I do all of our YouTube videos, go to the trade shows, etc. and so people rightly refer to me as salesman. In reality I just genuinely believe in the things we make and I love it enough to just kind of naturally make other people love it with me. All I can really promise you is this: you will never hear me say a cross word about someone who is following the rules or at the very least has the integrity to try to seek out the right answers. And, with that, I defer back to the OP with apologies for hijacking the thread.
 

qumefox

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I personally think this is a beneficial threadjack though.
 
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