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This was just announced today.
.
https://www.fda.gov/MedicalDevices/S...CampaignId=680
.
Interestingly it occurred while the ILDA meeting was going on in Bratislava, Slovakia and we've just finished an emergency board meeting, that included a conference call with FDA, to draft ILDA's position which will be available shortly.
.
~Brad
In other related news, Roberta McHatton is now a new board member and Brian Gonzales will continue to be president for the upcoming year.
Man this has been a long time coming, but regardless its pretty stunning for the FDA to come out so strongly against a firm. I can't think of any other such situation. Having been involved in this situation to some degree since 2009, I think it was the right move.
Todays response for those that wish to follow: https://www.cdrh.info/
I'm new around these parts--and have been trying to piece together who is in the "right" here. Would anyone be able to share what happened in layman's terms?
Ryan, welcome!
Short version, this Laserworld situation has been going on for something like a decade now. LOTS of history to unearth, very complicated. The FDA's statement is accurate in most respects, LaserWorld's is not. As small examples, the email they reference contains the following:
"Laserworld USA, Inc. holds no stock and there are also no transactions to any clients."
LaserWorld products are still being advertised and sold as of this writing through US dealers, just google Laserworld lasers and you'll find them.
In that same email they also write:
"Mr. Calhoun, I’m not the world’s laser police. I don’t know where US clients continue to source our products. It’s also not my obligation to do so."
So basically he is saying that they have no idea how dealers are still getting their products. Even if it passed the sniff test, that statement is completely undercut when you see that Laserworld is still running ads through Google Adwords in the US for their US facing site as of today 11/10/17. I superimposed a CNN article from today for a date reference.
Attachment 53164
You can read more in this warning letter from 2014:
https://www.fda.gov/ICECI/Enforcemen.../ucm438367.htm
Their recall from 2013:
https://www.accessdata.fda.gov/scrip....cfm?id=111195
Import Alert 95-04:
https://www.accessdata.fda.gov/cms_i...alert_254.html
And their denial of a variance from 2015, posted in 2017:
https://www.regulations.gov/document...15-V-4715-0004
Per FDA's statement they have been trying to work with them for years to bring them into compliance, and now we're here.
Fascinating. Thanks for all that info. Just figured I would try to understand the current events of the community if I am to join it! Speaking of (perhaps you know the answer): while I design my first laser projector to build, even though I plan on implementing safety features, I don't need to get FDA variance approval, correct? I'm just a hobbyist with only private, non-commercial showings. I do plan on being fully compliant however.
Great question.
People have lots of different perspectives on this, so I ill simply give you mine with the caveat that the best people to answer that question are always going to be the folks at FDA. There is no clear line about when a variance is required, so if the projector is compliant I would just report it and then you don't have to worry about it.
That said, my perspective is that if you are in your own home for your own private enjoyment, that does note require a variance. As soon as you start doing shows outside your home, I would suggest having a variance in place. Commercial or not does not matter so much. You could do a show say at a worship service for free, and that would still require a variance.
Use your common sense, and just plan to get one. there's no reason not to, its free, and you'll learn a TON in doing to the work to get it.
What the hell is cdrh.info?
Seems like an intentionally misleading, fake news page if you ask me!
Check out www.x-laser.org. They have a long history of doing this sort of thing.Quote:
Originally Posted by rns0504
verified..Quote:
Originally Posted by DanG
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Sorry for being late to jump in on this thread (been busy!), but I did want to clear up one misconception:
Actually, there is a very clear line. The FDA derives it's authority from it's congressional charter, which authorizes it to regulate COMMERCE. So as long as the laser product is (or will be) involved in COMMERCE in some fasion, then CDRH regulations apply.Quote:
Originally Posted by DanG
So - build a projector and use it in your basement? No variance required.
Build a projector and use it for a halloween display in your garage for the neighborhood kids? No variance required.
Build a projector and use it in a nightclub? BOOM! Commerce is involved and now you need a variance for the show *and* you need a manufacturer's variance in order to certify that the projector you built is compliant with all federal regulations. Note that even if you are doing the actual laser show for free, because it is a place of business and it is reasonable to expect that people will come to see the show (and buy drinks in the process), commerce is still indirectly involved and CDRH rules must be followed.
Yup. As stated above, no variance is required to do this.Quote:
my perspective is that if you are in your own home for your own private enjoyment, that does note require a variance.
HOWEVER, if you *purchase* the projector, then you have to have a variance, since the *purchase* falls under the commerce clause. You can only avoid this if you build the projector from scratch yourself. Even if you buy it with the intention of only using it in your house, the fact that you bought it means you need the variance. (Though you could let it expire once you have the projector in your hands.)
Note also that importing a projector from China (or any other country) requires you to fill out a customs declaration form (FDA form 2877) which specifies the plan for either bringing the projector into compliance (under a manufacturer's variance), sending it back out of the country, or destroying it. Failing to submit this paperwork can result in your projector being seized by customs officials at the border.
100% agree. Even if commerce isn't involved, the local authorities (especially your local fire chief) can make your life hell if you don't play by the rules. Having your variance is the first step in demonstrating that you know what you are doing.Quote:
As soon as you start doing shows outside your home, I would suggest having a variance in place.
Technically at a church there is no commerce (churches are tax-exempt), and I know several operators who do church shows without a variance, despite the fact that this is not recommended. I've spoken directly with the CDRH about this exact issue in the past, and while they *really* didn't want to admit it, eventually they did go on record stating that a church show would be out of their jurisdiction.Quote:
You could do a show say at a worship service for free, and that would still require a variance.
Even so, it's a bad idea. You can still be sued, and not having a variance will make you look like an idiot in court. But it's not legally required in this case.
This is perhaps the best advice in this thread. A variance is not something to be fearful of. It's a tool that helps you perform your shows safer. It also demonstrates a basic knowledge of laser safety, and that always looks good.Quote:
Use your common sense, and just plan to get one. there's no reason not to, its free, and you'll learn a TON in doing to the work to get it.
Adam
So, I have three homebuilt projectors -- two I bought from Buffo and one homebuilt by Saltyrobot but in a Laserworld case.
How would I go about getting a variance with this kind of equipment? The only shows I plan to do are in or at my own house or maybe a private (outdoor) pool/birthday party, etc. Never in a commercial environment.
All the projectors would need to be certified as compliant by someone who holds a current laser product manufacturer's variance.
At a minimum, that would include ensuring all units have the proper labeling and safety features installed (beam attenuation system, safety interlock, emission indicator, keyswitch, etc), filing a laser product report with the CDRH for these units (or at least modifying the projectors to be compatible with an existing laser product report already on file with the CDRH), completing the proper test paperwork to verify compliance under the QA/QC requirements spelled out in the product report, and re-labeling them as being a new product with the company name of the person who certifies them.
Then you would need to submit a laser light show variance application to use these newly-certified products in a commercial application.
In short, this is a lot of work! It can be done, but if your ultimate goal is to use a projector commercially, you are better off purchasing a legal unit right from the start. But if your plan is only to use it in your home, then building a home-made unit (or buying one from a friend) is OK.
Adam
Let me clear up something guys - a "commercial" environment is not required to trigger the requirement to have a variance. FDA has been pretty consistently clear about this over the past couple of years. The church distinction has been walked back - along with lots of other things that used to be passable.
Adam is absolutely correct that FDA derives their power from the commerce clause, however this is why they have tortured the definition of a "manufacturer" to include people "manufacturing" shows. Any show that incorporates a "public" display - whether or not commerce itself is involved per se - can be regulated by FDA because the show is "manufactured" by a show producer.
We had a detailed conversation about this at the ILDA conference and tried to flesh out where those gray areas were in commerce, public, private, etc. At the end of the day, it comes down to one's opinion, and more specifically, the FDA's opinion.
Their touchpoint is public safety so any display which is accessible to the public, outside of your home, generally requires a variance. Inviting over kids to see a laser show may even count because the display can be accessed by the general public, even though it is in your garage. I would think that is a distinction they are unlikely to assert unless there is an injury event, but if there is, they would almost certainly classify such a halloween show as a public display. This is also why the church distinction was walked back - almost anyone can walk into a church service. It's a public display, and the fact that the show is being done for free really has no impact on whether the show is safe for the public to view.
D'oh! Just noticed the user-name swap. Sorry Dan - didn't realize who I was speaking with!
That being said, I will also admit that my information comes from Dale and dates back to *before* the CDRH came up with the tortured "show manufacturer" definition you mentioned, so it may well be that they believe they can now claim jurisdiction over a non-commercial show.
Although I also believe that this new definition has never been formally challenged, and honestly I think any decent lawyer could slay that one. But I also don't want to be the guinea pig!
While I agree in principle that the CDRH should derive their power from a public safety standpoint, that is not the way their charter reads. And if it *is* the current position of the FDA that they are a safety agency, they really need to petition congress to change their charter.
Adam
So am I reading that right? In order to get the variance completed you need to have someone who already manufactures laser equipment with a variance to approve of your home made laser? Or did I misinterpret?
I am all for safety, stubbornly so, but that rule doesn’t seem geared toward safety. What malady is it preventing? Profit loss? It seems like it was lobbied by some big business in order to stifle competition. And all it does in my case is make it really difficult to have a couple friends over in my garage to smoke a joint and watch some lasers without some government entity knocking down my door (and I’m in a legal state so it ain’t for the weed).
Typically if you build the projector yourself and want to make it legal to use in a commercial show, *you* file for the manufacturer's variance, *you* write and file the laser product report, and *you* certify that the projector you assembled is compliant. After all, you are the manufacturer! :)Quote:
Originally Posted by ryanlightsitup
This is the path I went down with my projectors. It's a huge pain in the ass, and it took me the better part of a year, even with a paid consultant helping out. Note also that I don't sell my gear to others. I just wanted to be able to certify it myself.
Alternately, you can hire someone else to do all this work for you. It's expensive, but it saves you from having to educate yourself on all the little details regarding laser product manufacturing and certification.
The regulations were meant to apply to a company that wanted to start building products that contained lasers, since those products would eventually be sold to others to be used in public, or used by the original company on members of the general public. Thus, they had to apply to be a laser product manufacturer first. (Obtain manufacturer's variance.)Quote:
I am all for safety, stubbornly so, but that rule doesn’t seem geared toward safety.
Then they had to submit a laser product report that detailed how they were going to build the product, how the lasers would be incorporated safely into the product, how they planned to comply with the various requirements, and what sort of testing/quality assurance program they had developed to ensure they didn't screw anything up and put the public at risk with their new product.
Then they could start building and selling laser products, so long as they adhered to the policies and procedures they outlined in the laser product report. Oh yeah, and if the products were laser projectors for laser light show use, then they would also need to ensure their customers had their laser light show variances from the CDRH before they sold them the laser projectors. (That protects the public against stupid/careless/reckless operators, at least in theory.)
No, more like the FDA was tasked with regulating a new and potentially dangerous product that was initially only used in medicine and scientific research. Read up on the Therac-25 to see what can happen when you don't have proper regulatory oversight on new medical equipment. Has the pendulum swung too far in the other direction? I would say yes. But the original idea is sound. The devil is in the details.Quote:
It seems like it was lobbied by some big business in order to stifle competition.
In truth, if you want to run a laser projector in your garage while you and your buddies smoke - just build a laser projector and run it. No one will mess with you, and you'll have a lot of fun. Be safe though - don't crown-scan. But honestly the chance of anyone saying anything about what you do in the privacy of your own home is essentially zero.Quote:
All it does in my case is make it really difficult to have a couple friends over in my garage to smoke a joint and watch some lasers without some government entity knocking down my door (and I’m in a legal state so it ain’t for the weed).
Hell, as it is the CDRH doesn't have enough inspectors to keep up with the huge volume of legitimate, commercial laser shows. They don't have the manpower to even think about knocking your door down. You aren't on their radar and never will be. (Nor should you be, in my opinion.)
Adam
Ah okay. Thanks for laying it out for me Adam! I find the challenge of exacting specifications in safety and otherwise fun to do. But yeah, just literally for home shows.
I do need to be the devil here for a second, in the spirit of hoping to find clarity since we all do it - and there is a whole subsection of this forum for "BuySellTrade". Hank commented that he has three projectors - two bought from buffo and 1 modified and built by Jason. And yet, buffo just stated, "Note, I don't sell my gear to others." (which I know means the units you've varianced for your own commercial shows) I don't suppose there is any official view on the home hobbyist recouping some of their investment with another home hobbyist when upgrading or, cleaning off a shelf or, getting out of the hobby altogether. It certainly shouldn't fall under the CDRH's umbrella but, by definition, maybe it legally does. We're ALL pretty much guilty of that at some point or another. Even if I trade someone a home constructed laser projector in exchange for cutting my lawn for the summer - couldn't that be deemed as a form of commerce?
Good questions, Brad!
But Buffo never represented to me the two projectors I bought were varianced, and knowing Adam, he likely explicitly told me they weren't (not that I remember that).
The basic answer to your question Brad is yes, it is.
Variance holders are prohibited from selling, loaning, leasing, or otherwise transferring (power functional) high powered laser products to persons without variances.
Quote:
Originally Posted by DanG
Lets clarify that a bit. I can sell you a 500 Watt Co2 no questions asked, provided I'm sure your not going to export it because of ITAR, provided its an approved laser product. Only laser show products, certain Demonstration Laser products, Imports, Medical, and a few other types of devices require paperwork on the customer end. In medical, its pretty much "prove your an MD", and you get the laser.
~
Lab or Industrial lasers not classed as a item of interest under ITAR flow freely...
~
Steve
It reminds me of the whole AR-15 thing and which parts are actually the "regulated" portions of the build, the 80% lower, etc. In my understanding, Adam could have removed the laser source(s) from the housing, declared that he's selling you a laser source for "lab use", sold you the housing separately, and leave it up to you to re-assemble it. That's technically legal as far as Adam is concerned as you don't need to hold a variance to purchase a laser for "lab" use.Quote:
Originally Posted by mixedgas
Steve, what are the rules surrounding purchasing a "lab" unit? How far off base am I?
Dang. Imagine the party we can all have at LeavenworthLEM. That building looks to be perfect for laser mapping.Quote:
Originally Posted by DanG
Attachment 53278
And tall ceilings!!
Attachment 53279
This is the dirty little secret hiding in the closet of every hobbyist who eventually went on to get their variance. You can't legally sell a laser projector to someone unless it's certified under a manufacturer's variance *and* the buyer has their laser light show variance. But as you said, there is a buy and sell area here on PL where things get sold on a daily basis.Quote:
Originally Posted by Bradfo69
Nearly all of those projectors sold are being used by hobbyists/enthusiast's in their homes. But that doesn't make it legal. It just means that you are flying below the radar. Will the CDRH go after you? Almost certainly not. But if you want to be technical, it is against the law. (See my reply to ryanlightsitup above.)
Absolutely. You are violating the terms of your manufacturer's variance if you do that. Does that mean I think you should stop? No. Use your judgement.Quote:
if I trade someone a home constructed laser projector in exchange for cutting my lawn for the summer - couldn't that be deemed as a form of commerce?
I definitely told you that they were *not* certified projectors. :) In fact, at that time, I didn't have my manufacturer's variance yet, nor had I filed my laser product report, so there would have been no way for me to certify those projectors.Quote:
Originally Posted by HankLloydRight
Dan, this also applies to the general public, doesn't it? I didn't think you had to have a variance to fall under 21 CFR 1040... So even if someone does not have their variance, they still can't sell class 3B or Class 4 projectors that aren't certified, right? (Playing my own devil's advocate here...)Quote:
Originally Posted by DanG
Funny enough, that's pretty close to what happened. Hank re-built one of the projectors into a larger case at SELEM, and ended up replacing some of the lasers in the other unit as well. Although that was after I sold them to him...Quote:
Originally Posted by hitekvoop
I'm sure we could have gone through some artificial motions to make it "legal" on paper at least, but in the end it was two friends working out a deal to benefit each other. I'm sure the CDRH has bigger things to worry about. The difference (and I'm splitting hairs here) is that I knew Hank was only going to use them in his living room *and* I knew Hank wasn't going to do anything careless with them.
But if someone approaches me and asks me to build them a projector and then certify it for them so they can use it in a commercial show, my answer would be no. That's a huge liability risk I'm taking on, and there's no way I can compete with the prices of other commercial units on the market anyway, so there's no incentive for me to do that. That's why I said I don't sell my own gear.
Adam
i would add almost every laser show company breaks that law.
not all of them... but most of them
Quote:
Originally Posted by buffo