Seller's product certification requests?

[allthatwhichis]

I have been thinking since "el gringo loco's" post last night that we here on the forum may want to start holding laser projector sellers to the same standards we are held to by the fed. By laser projector sellers I mean professional sellers; not buying a DIY projector from a fellow forum member. If a seller posts they sell projectors, we hold them to providing the needed documentation from the CDRH before we agree to buy any full projector from them. I know there are a few that request this once a seller posts a thread indicating they sell full projectors; my thought is we need to come together as a forum and ALL do it.

Thoughts?

[norty303]

Irrelevant for a good percentage of the population of the forum.

I think it would be unfair for PL to restrict sales of projectors without CDRH compliance as this would stop users outside of the US being able to benefit.

[Displaser]

Most foreign projector manufacturers (compliant or not) are going to expect either the importer or end-user to do the heavy lifting on this. To the best of my knowledge, even those that make a compliant projector do not have accession numbers.

Example:

RGBLasersystem - compliant mfg., Importer holds accession number
KVANT - not compliant (last time I checked, may have changed?)
Neo-Laser - compliant mfg., Importer holds the accession number
Others?

Compliant with an accession number likely prices this out of the reach for most on PL.

Is there a means to legally import a non-compliant projector into the US if the proper documents/steps are taken to ensure compliance after arrival, before placing the product into commerce?

[absolom7691]

Perhaps a list of compliant vendors for those in the US. Then, anyone who needs to buy from a reputable and compliant seller knows where to go and may save them a bit of a headache.

[dsli_jon]

I think it would be unfair for PL to restrict sales of projectors without CDRH compliance as this would stop users outside of the US being able to benefit.

I don't think he was proposing 'restriction', simply that it is good for *all* (not just US PL-members) to put these 'CHOEMs' (...and any other Countries, for that matter...) to the 'test' -

ie: Please supply us (along with your 'amaZing prices'...) proof your product is compliant with EU / IEC safety-regs, (and/or FDA Regs, if being-offered for-sale in the US...)

..I (for one) think this is great advice from allthat, - for everyone, here - since we've seen examples / heard first-hand reports of how, for example, (some) LW-products are not even-compliant in their own homeland, which is pretty-succky to find-out, post-'they-gotz-yer-money', when you go to register it with the Guv, and they 'bounce it'...

Sure, if a potential buyer does not 'do his / her homework', pre-purchase, well, then that's sort of their 'own fault'... But if, at least the PL community were to 'pressure' - or even require - that those who wish to peddle their wares, here, *also * provide proof that their gear is, indeed, compliant (with the applicable-reg body), so post-sale paperwork, etc, won't be a headache, and, more-importantly, ACTUALLY SAFE... (ie: doesn't spit out a spurious full-power beam when you turn on / off / connect DMX, etc, etc...)

Is there a means to legally import a non-compliant projector into the US if the proper documents/steps are taken to ensure compliance after arrival, before placing the product into commerce?

Typically, the best-way would be to work directly with the overseas OEM / ask for CAD-drawings / schems from the potential-manufacturer, and then, *you* do the States-side Product Report / get it Certified... IF there are 'deficiencies' (ie: LSDI going back to RGB and having-them integrate a hard beam-shutter, with delay, tied to the interlock-circuit, etc - before they submitted to FDA for certification, etc..) then you work with the OEM to get those corrected', before they ever land on US soil, for sale...

Of course, you can work with the FDA to get something 'brought-in' on 'temporary import-bond', etc, while you work thru this process, etc, (see attached 'RADEC', below..) but you can't (legally) go selling those / doing shows, etc, till they're actually compliant / approved... Course, you need have your own 'Show-Producer Variance', so the FDA will 'feel comfy' that you, in-turn, know / will-follow the Regs, etc...

Yeah, sux to have to wait / take the arduous 'high road', but in the long-run, it's the best-way to 'CYA'...

Hope this helps...

Dan?
j

[Displaser]

Thanks Jon.... I remember seeing that document some years ago when I was considering purchase of a Neo-Laser system located in Europe, but the purchase fell through.

Greg

[mophead]

Not sure if i'm following this to aaron's intent, sorry long day, but do you want to start getting "firm orders" in the works then make sure the mfg provides the correct paperwork?

Maybe some of these "high end" systems being sold as FDA varianced could face some expensive visa/mastercard chargebacks since they are not compliant in the US. Visa don't want their cards being used to break Federal law, do they?

[allthatwhichis]

My thought was simple and mainly to start a discussion. Yes each country is different and my communicaed thoughts are only from my country's perspective; each member should look at this from their own country's laws. Mine just happens to have the strictest laws...

If company XYZ laser projector company wants to post a for sale thread here, we as a community and before any member agrees to buy one of their projectors, demand they prove their product is compliant with what ever country's regulations a possible buyer is from AND be certified in that country. It is actually illegal for any of us in the US to import a non-certified projector and I think it is our responsibility to not only keep ourselves legal, but to keep our self moderated forum free of thread that would possibly cause us to break our own import laws because a projector company is not compliant.

Again, this is only for full projectors; OEM laser manufactures like Laserwave and Ultralasers can post for sale threads all they want as OEM products need not be compliant for import, as far as I know. To me this is mainly to keep us and the forum on the correct side of the law. This would actually impact few members as most here are building their own projectors for personal use.

And to re-state, i just thought to open a discussion. I hate to see one or two members pushing this with little success.

[X-Laser]

Guys -

I am going to jump in real fast to clear up something here:

An accession number means absolutely nothing in the grand scheme of things. For the purposes of this discussion, it is totally meaningless.

An accession number is a file number in the FDA system that allows you to reference the 'location' of your correspondence when you contact them. Any variance app, product report, etc. gets an accession number. That does not mean that the report is satisfactory, or even complete, or anything other than a greeting card... it is a file number and nothing more.

Where this gets confusing is that manufacturers ARE allowed to import laser products (having been properly product reported) for testing, R&D, etc. using an accession number. But, they are not allowed to sell them. Also, no one "holds" an accession number... it attaches to paperwork filed by an entity. That's all.

Step one is making a product compliant whether here or somewhere else.

Step two is filing the paperwork attesting to compliance.

Step three is having the paperwork approved.

Step four is being able to sell.

An accession number does not even reach step three. It is illegal to import a radiation emitting product from overseas unless that product is a) properly product reported, b) the manufacturer of record has an approved variance to introduce product into the US for sale, c) the manufacturer maintains a robust QA program with written records demonstrating ongoing compliance, d) the manufacturer designates a state side entity to handle correspondence, warranty repairs, etc. and trains the personnel at that firm to including or above the level required for an LSO who must also then have a variance to handle the product, e) etc., etc.,.

I am really trying not to get onto a high horse here and God knows that I have no interest here in selling product because the stuff we make is not really useful for you guys, but I am constantly amazed at how readily people will post that they have purchased, imported and/or manufactured uncertified, and/or otherwise illegal laser products on a public forum indexed by google.

You having a variance is great. it does not mean that you can legally buy whatever you want and tinker with it. Certainly the FDA has better uses of their time than raiding the homes of hobbyists who undertake laser oriented projects... but I think that people need to at least understand the liability in doing it. Having an accession number to wave around is about as useful as waving around a driver's ed handbook when you get pulled over while driving a vehicle without functioning taillights. And now, I step down from my horse and await the shellacking. =)

PS: There is no such thing as a "compliant manufacturer." Manufacturers can make a product that is compliant with one standard, and non-compliant with another. What matters is how well the product meets or exceeds the applicable performance standard and that varies by model and even by unit.

[allthatwhichis]

Thanks for the clarification although this may go beyond the scope of my hope for this discussion. No shellacking here, but since you brought it up, I am not sure many of us who have bought an uncertified projector from another country even knew it was illegal when we did it. I know I didn't until the safety meeting after last year's SELEM over a year later. What are we supposed to do after the fact, send it back?

I am currently working to get my DIY projector certified and varienced; have spoken to Dan over the phone and twice through email, although Woody or Dale would eb the person looking at my documentation mailed yesterday... and today. (didn't realize the application goes to Fisher road and the report goes to New Hampshire Avenue) I reproduced all the safety features in my imported projector so it can be certified and varienced also; even if I have to send an ademdum back due to a slightly different beam path in area "A". I have done a full rebuild and consider myself the manufacture now but that doesn't change the fact of how I got it.

My purpose for this thread is to discuss if we should, as a community, work with potential full projector sellers posting here to get them to certify their projectors before anyone here commits to purchasing one and, in the US atleast, importing them wrongly. Sicne these are Google cached, it would look good if we are trying to make projector importers compliant to something. I figure if they are compliant to the US regulations that would fit the bill for most other countries.

And since you have clarified assension number... is a docket number one step further back? You get a docket number before you get an assension number?

[X-Laser]

Yea, I kind of went off into right field and did not give you the credit which I genuinely think you deserve for proposing something like this. I think it is a great idea.

As for your question, I hate to say that I don't know but I have never really fully understood the precise relationship between docket numbers and accession numbers. My cursory understanding is that they are one in the same, or at least serve the same basic function. I am though open to being corrected on that.

The bottom line is that most foreign sellers are not going to get into compliance and even if they do they are not going to stay in compliance. It is too much work and much too expensive. US compliance adds, on average, 40% to the cost of the projector for us and it is sometimes as high as 200%. Very seldom do people want to take on that level of expense when others will just ignore it and take their sales.

As for what to do with an illegal projector... that is tough one. I'll tell you what I did: My very first unit was illegal and as soon as I discovered knew better I threw it off of the back of our loading dock.

In any case, kudos. Let me know if I can help.

[dsli_jon]

My purpose for this thread is to discuss if we should, as a community, work with potential full projector sellers posting here to get them to certify their projectors before anyone here commits to purchasing one...

Dan's oh-so right - it's an 'ant hollering at a fright-train to STOP'.... But, if, as you are excellently-encouraging, if - at the *very least* - when new 'OEM's post to PL, selling their wares, we, as a community, say: (nicely) "Please supply us (along with your 'amaZing prices'...) how your product is compliant...blee, blah, blah, etc.."

...at least that spurs USA PL'ers to 'think before they plunk' (-down their cash...) and others, in the EU / beyond, to at-least *consider* safety over 'cheapness'... Then, all that 'steering-peeps away from the dark-side' gets cached, and PL, as a whole, has a nice 'high-road / CYA'-aspect to it... I mean, heck, we've even got a growing 'SafetyWiki', here, woohoo!

a docket number one step further back? You get a docket number before you get an assension number?

CORRECTION: The 'Docket number' / letter, is like a 'return-receipt', acknowledging receipt, and entrance into 'the line' (...like 'take a number', in line at the meat-counter...) - it is what you 'first get', from them...The 'Accession number' is issued when they 'officially submit it', internally, for entrance into 'the-process' / review, etc, which gets filed in the Federal Register / FDA DB for referral-to / amending comms-about, later, whether approved or not... This number 'changes', as there are 'communications' between you / FDA, in subsequent-years (...petitions for renewals / amendments, etc) ...

...But again, at the *most*, getting that-far into the 'process', is like 'submitting an-app for auto-credit' - does *not* mean you are, or-will get any sort of approval / you can just 'walk off the lot with the car-keys'... So, sellers saying 'all you need to do is send in the paperwork, and you can take delivery on our lazor-box', is really (...according to Laser Notice 51...just 'citing the source', yet-again..), contradictory to current FDA-policy...

IF it's a genuinely certified-system, well, that, (to me, personally - FDA *still* says end-user Var. must be in-place before shipping...) would be 'one thing' -
But shipping an *un-certified* / unsafe box, and before the customer has their Var. approval...that's really a double-asking for trouble-whammy...

...'Ant yelling at the train'... But we can *try*, yes? Good call, Aaron...

j

[mixedgas]

The sad part is even if PL users standardized a design, sourced parts, made it compliant, offered it as a kit, etc. We could still not make the process easier or faster.

Why? Because it is the manufacturer who does the quality control and is held responsible. While this is a great safety scheme for medical devices, in the modern laser show "disposable" box world, it does not fit the world model. He/She who assembles the device IS the manufacturer, under the law I probably can't sell you a kit* or a partial kit, without the device coming back to me for inspection.

Since there is no alternative of using a standardized design and having the end user do a checklist, the best PL can do for US laserists is to ask sellers of commercial products to show us something more then a accession number, what that may be, I do not know. I suspect the letter from FDA stating approval of a manufacturing report might be a start.

Now where are you going to differentiate what a commercial sale is? Two identical units? If someone sells one 19,000$ RGB a year, are they a manufacturer in the eyes of PL? Is it sales volume or sales gross that makes you a manufacturer?

Tough problem, but perhaps PL users should ask about compliance as a means of educating the sellers. Even if it has no teeth and is a gesture at best.


*Low power hene kits have been sold, the legal premise being a .1 mW short hene tube (bar code tube) cannot physically change enough to reach powers above say .15 mW. I own a ETS-4200 hene kit from Heathkit. The tube is from 1987 and still runs. I'll read the documentation some day and see what the catch was.

Steve

[flecom]

additionally I am willing to bet the reason KVant has not made compliant projectors is because they probably sell 1 out of every 1000+ projectors to the US... the US is just not a major market for lasers/laser shows...

not like everywhere else (europe/south america/etc) where every night club is trying to give everyone who is photosensitive a seizure lol

[dsli_jon]

additionally I am willing to bet the reason KVant has not made compliant projectors is because they probably sell 1 out of every 1000+ projectors to the US... the US is just not a major market for lasers/laser shows...

True, but, Flip: I'd bet that they could (potentially) sell more, if they simply took the time to work with a States-side Importer (that has a clue... and get them certified - they're not all that 'far-off' - They've already got: proper-type keysw., laser-compartment door interlocks, emission-delay, and no 'dangerous tie-ins' to silly DMX-activated 'demo-boards' that tend to spit out a beam when you shut the thing off...

..I'd only see them needing: Emission indicator near output window + hard beam-shutter, both tied to emission-delay and interlock circuit, ensuring the interlock circuit is properly tied-into the ILDA I/O, etc, and proper US-labelling... It's really *not* all THAT hard to make a projector compliant, nor is the Product Report all that 'brutal' - the real 'PITA' is the arduous process with the FDA, because it's a ghost-town, now... But, even-so, it's really not all THAT hard, and in-theory, Kv's would then-be more attractive for pros in the biz, who have to worry about liability, etc...

ie: I've heard that RGB Hungary, is certainly 'glad' they worked with LSDI / Greg M. to get the Compact-line up to par, for this very-reason (more US sales...) -
Now, LSDI, are the ones that actually *certified* them with FDA / are the Importer / 'manufacturer' of Record, but they put the onus on RGB to make them 'compliant' before they ever landed... Very smart way to do it, cause then, he's not having to re-work thier boxes, etc - He simply gave them a 'checklist' / worked with them on the CADs, etc, and - they did it... Result? They are probably the best-selling *legal* import, (in their 'class'), as a result... And man, are they nice. (imho..

peace-out...
j

[gottaluvlasers]

Few things-

1) Aaron. AWESOME idea. bottom line to this idea is plain and simple. there are TONS of manufacturers and projector makers who pop up here quite often. when they advertise their product(s) they are advertising and promoting it to a world market. for the U.S. PL members on this forum we should immediately ask them their credentials. I will tell you now, and this is from the horses (CDRH) mouth- there is only TWO (2) foreign laser manufacturers with valid VARIANCES and CERTIFIED products in the U.S. they are RGB LAser Systems and Arctos. there is not, never has been, never will be (i would bet my left nut) a chinese laser projector manufactuer with a CERTIFIED Laser projector system.

Accession # is as useful as my dogs license number on their collars. it means NOTHING!

I am honestly thinking of performing an experiment. I am going to send in a BLANK product report tomorow and withing 2 weeks i will get an acknowledgement letter back with an accession number in it. as dan and jon stated all an accession # is is a filing number saying, hey- thanks for sending us some mail. here is your confirmation number that we opened your mail.

2) my understanding after some very recent turmoil is this:

Accession # is (as stated previously) simply a number to track your submission with the FDA/CDRH. it provides NO informaiton as to its approval or certified status.

Once a submission is officially entered into "non rule making" status with the FDA (non rule making because any decision made by the FDA on your submissions does not affect any official "rules" or regulations. It is "varying" (hence- variance) from those rules.) sorry- once your submission officially makes it to this point it recives a docket number. Once a docket number is assigned it is now officially being "looked over" and is officially being considered for approval. it IS NOT an approval or denial. it is simply your docket number for this specific request for approval.

just like if you go to court. lets say you sue someone. when you file the paperwork, you will immediately get a case number. this case number (accession #) does not provide ANY outcome informaiton or prove guilt or non guilt. it is simply your identifier. once the case makes it to the judge, and lawyers get involved and court date gets set- NOW you get your docket number. this is the offcial number identifying your specific case and your specific requests, compaints and suits.

the docket nuber which is assigned to you from the CDRH is the number that will become your variance number. NOT the accession #. the docket number identifies your specific requests, applications, decision status(s) and documents.

3) KVANT Laser systems WILL BE U.S. certified properly and has already begun. I am *not* the one doing it. but the official reporter and perosn doing the certifying is more than capable of it. he prob has more experience than all of us here combined. So, this will not be a problem.

-Marc

[dsli_jon]

I went with Kvant... don't want anything to do with LW

Yaaay! yet again, to your suggestion...

Yo Marco -

...once your submission officially makes it to this point it recives a docket number. ...just like if you go to court.

Actually, I thought had remembered it exactly sdrawkcab.....buuut, I didn't...

The 'Docket number' / letter, is like a 'return-receipt', acknowledging receipt, and entrance into 'the line' (...like 'take a number', in line at the meat-counter...) -
it is what you 'first get', from them... See HERE for an 'example'...

The 'Accession number' is then-issued when they 'officially submit it', internally, for entrance into 'the-process' / review, etc, which also gets filed in the Federal Register / FDA DB for referral-to / amending comms-about, later, whether approved or not... This number 'changes', as there are 'communications' between you / FDA, in subsequent-years (...petitions for renewals / amendments / annual-reports, etc)... Interestingly, this def is pretty spot-on: http://www.businessdictionary.com/de...on-number.html

But, again, your 'point' was-correct - as has been re-iterated to-death, here ..it *ain't* any sort of 'approval' / 'certification', and it's a super-shady (and illegal) way for these overseas Co's to be racking-up sales...

...there is only TWO (2) foreign laser manufacturers with valid VARIANCES and CERTIFIED products in the U.S. they are RGB Laser Systems and Arctos.

Just a 'mild correction', as recently as last-month, there was a little 'fracass' over the RGB Compact-line - reason-being, the Client whom we helped get their var-processed, actually put "RGB Lasersystems Compact 2 / 4 / 8" in their App. and the, uh, 'CDRH 'guy' would not approve their inclusion, because he said he 'couldn't find them in the DB'...

So, I said, 'well, shoot'... (although the 'officer' should have been astute-enough to find all the projector-info via the *actual* Importer of record / Certifier's (LSDI) Variance#s, but he "could not"...) ...'please 're-check', listing "LSDI" as the 'manuf', and 'RGB_XXX', etc, etc as the projector, and 'voila', he found them / the info...

Point-is, although - Yes - those Projectors *are* compliant / certified, it is 'thru' LSDI's Var., not RGB-directly, so, anyone wishing to 'add' those systems to their Var. (for, ie: 'x-rentals', etc) you would not want to list those projectors as "RGB Lasersystems"... Here's the LINK... just an 'fyi'...

KVANT Laser systems WILL BE U.S. certified properly and has already begun. I am *not* the one doing it.

Just 'for the record', when I said:

...if they simply took the time to work with a States-side Importer (that has a clue...) and get them certified...

..I was *not* referring to You, just so ya know... I was simply speaking about *anyone* doing that (working with a foreign-OEM to get compliant), States-side, would, yeah, best-be someone 'with a clue' / experience... Which, I know, you have... 'you have done well, Grasshopper'... Just so'z I wasn't 'misunderstood'...
I'd hate to get the 'Prick of the Week Award'...again...

peas..
j

[Displaser]

My wording was wrong from my earlier post - my intent was to clarify that even the foreign projector manufactuers that have varianced product in the US, did not do the legwork/paperwork for this, as Jon has clarified, they worked with a US manufacturer to get to this stage.

LaserNet/Neo-Laser. The Trinity Pro/Semi-Pro and Matrix laser projectors are Chinese and US varianced based on what I have been told by LaserNet. I've also been told by Jim Hardaway, who consulted for Neo-Laser, that versions of these systems are US compliant as they ship from China.

I'm not defending non-compliant products, nor am I wanting to perpetuate any arguments here, I just wanted to point out that none of these manufactuers would have approved products in the US today, if someone in the US didn't import these products and work with the foreign manufacturer to make them compliant, ultimately allowing for a varianced product.

Greg

[taggalucci]

...I just wanted to point out that none of these manufactuers would have approved products in the US today, if someone in the US didn't import these products and work with the foreign manufacturer to make them compliant, ultimately allowing for a varianced product.

This suggests a manufacturer outside the US could not apply for a Manufacturer's Variance. Is this true?

[Displaser]

This suggests a manufacturer outside the US could not apply for a Manufacturer's Variance. Is this true?

To the best of my knowledge, these foreign manufacturers could do all approvals and obtain a variance for the US, but as our recent wave of "advertisers" have stated, "they don't have to".

It would appear that the responsibility falls onto the importer/US manufacturer/end-user to abide by the law.

[X-Laser]

This suggests a manufacturer outside the US could not apply for a Manufacturer's Variance. Is this true?

No, the issue is that foreign manufacturers can apply for and obtain variances, and some even have, the problem is that the requirements are so high that it is just not worth it for most of them... especially when sneaking products in and making it your problem is marginally easy.

[taggalucci]

Surely they'd only have to do this once per model. And if they're after volume sales (which they clearly are) the cost of certifying per unit would be quite low.

If they make units with similar base specs then couldn't additional models potentially just be extensions to a single Variance?

CNI a Chinese company have variance documentation for some of their lasers I believe. I can't see why a Chinese laser projector manufacturer can't do a little more work and certify their projectors. Surely that would be a huge selling point and a point of difference from their own competitors.

[norty303]

I think another factor to consider is that all the Chinese manufacturers use parts that have limited availability windows.
By the time they've managed to get a variance for a unit, they can no longer build that unit. In fact, the speed of progress in the solid state laser world, and in particular the small to medium size projector market means that any design is effectively superceded before a proper variance appears to be able to be granted.

You try and find a Chinese manufacturer selling a projector the same as they were selling 2 years ago.

And this is not just for Chinese manufacturers, I think it would affect any mass producing projector manufacturer using some non-proprietory parts

[X-Laser]

That is not really the issue...

First the entry barriers are extremely high including developing infrastructure for ongoing record keeping requirements. CDRH terms it is a "quality assurance process" which basically means making sure that projectors remain in compliance through their entire lives as previously certified. This is pretty difficult by itself, but there's more...

21CFR1040 specifically states that unless you jump through 15 very expensive hoops, user maintenance - like alignment - is disallowed. So you are either faced with adding electrical, redundant housing interlocks and a bunch of other things which totally change your manufacturing process, or you have to tell your customers that they have to DHL their laser back to the factory every time it has to be cleaned or serviced.... which of course would never happen and cause your QA process to be disallowed resulting in a loss of your variance.

So then the only other option is to open a US manufacturing facility to handle certification, service, etc. which of course is obscenely expensive and even if you do it then the US firm has to be set up as the manufacturer, be subject to the variance terms, etc. and even then they couldn't sell to anyone who didn't already have a variance which nearly completely eliminates their ability to do volume sales making the whole thing not cost effective.

There's a lot more too, but that it perhaps the single biggest set of issues.

[X-Laser]

Sorry Norty, I wasn't responding to you when I was writing.

Yes, that is another problem. Parts availability is very sticky.