Page 1 of 2 12 LastLast
Results 1 to 10 of 14

Thread: Making the CDRH and FDA happy

  1. #1
    Join Date
    Sep 2006
    Location
    OH, USA
    Posts
    114

    Default Making the CDRH and FDA happy

    I really feel like I'm fighting an uphill battle, and I certainly didn't expect to have so much trouble until I started filling out paperwork.

    Here's where I stand. I plan to make a small laser show company here in Columbus, OH. I know I need to be varianced, I know my projector needs to be varianced, and I know each venue has to be varianced. I've ordered DT-40 Pro scanners, with AlphaliteXC Pro software and interface. I purchased a $300 casing (w/ shipping) which I'm now finding out I spent $250 too much for because although the casing was varianced, I found out it doesn't legally transfer. Now I'm finding that without an accession number, I can't "legally" import a laser, and so I'm stuck with all this gear, with no laser, and a huge amount of CDRH red tape in my face anywhere I consider buying one.

    I feel like this idea is falling apart before it ever started. I'm sitting here with a very tight budget (now sitting at about $2000) and I still have no laser, which is kind of important for a laser show company. I'm calling a CDRH rep tomorrow, and possibly my area variance officer to see if I can sort things out, but I must say that today has been a very discouraging day.

    Does anyone know of any US vendors that I can purchase a 1 watt 532nm DPSS system with a CDRH certificate for about this price? Please, any help would be appreciated.

  2. #2
    Join Date
    Oct 2006
    Location
    Central Florida
    Posts
    7,067

    Default Re: Making the CDRH and FDA happy

    Quote Originally Posted by BoomDog
    I really feel like I'm fighting an uphill battle, and I certainly didn't expect to have so much trouble until I started filling out paperwork.

    Here's where I stand. I plan to make a small laser show company here in Columbus, OH. I know I need to be varianced, I know my projector needs to be varianced, and I know each venue has to be varianced. I've ordered DT-40 Pro scanners, with AlphaliteXC Pro software and interface. I purchased a $300 casing (w/ shipping) which I'm now finding out I spent $250 too much for because although the casing was varianced, I found out it doesn't legally transfer. Now I'm finding that without an accession number, I can't "legally" import a laser, and so I'm stuck with all this gear, with no laser, and a huge amount of CDRH red tape in my face anywhere I consider buying one.

    I feel like this idea is falling apart before it ever started. I'm sitting here with a very tight budget (now sitting at about $2000) and I still have no laser, which is kind of important for a laser show company. I'm calling a CDRH rep tomorrow, and possibly my area variance officer to see if I can sort things out, but I must say that today has been a very discouraging day.
    Damn... I feel for ya. I'd love to make a laser show company but that seems like WAY too much BS. Like anting to show off guns at elemetry schools. :roll: Its a lot of work just trying to get a projector going. I'd almost wait until your atleast drawing something on the wall before I thought about showing it to people, even on a small scale. Then worry about certs and variences. At least you'll be haing a little fun at home to keep you going throught the red BS... :idea:
    Love, peace, and grease,

    allthat... aka: aaron@pangolin

  3. #3
    Join Date
    Sep 2006
    Location
    OH, USA
    Posts
    114

    Default

    Yea I keep forgetting that the biggest reason I want to do this is because of the laser, not because of the business. I just don't want to shoot myself in the foot by building a really nice projector, and then being told that it isn't CDRH compliant and can't be used. Aixiz currently has a 1w for sale for $2350, which is the best price I've found so far, but let's just say I hope I get a few extra $$ for christmas to pay off the excess credit card bills. I just sent them an email asking about their CDRH compliance, but they advertise as OEM products so I may have to do a bit of work to get them ready. I'm just getting really confused as to what I am allowed to implement myself (be it shutters, key interlocks, etc.) and what the laser needs to be in order for it not to be just shot down by my variance inspector. I suppose talking to the CDRH will help clear things up. I'll keep everyone posted.

    If anyone knows anything cheaper, let me know.

  4. #4
    Join Date
    Jan 2006
    Location
    Charleston, SC
    Posts
    2,147,488,525

    Default

    If your projector isn't CDRH compliant, you can MAKE it compliant. It's not a one-time, go-or-no-go thing. If they reject your design, ask them why, and ask what else you need to do to make it compliant.

    Since you are a hobbyist that is about to become a professional, you are in the no-man's land between the two. If I were you, I'd remind the CDRH (repeatedly, if necessary) that you built this projector yourself for your own amusement, and have only now decided that it might be a good idea to get it varianced and start doing shows for profit. As such, you recognize that the projector in its current form may not be compliant, but since you aren't involved in any commerce with it YET, it doesn't need to be. Your goal is to get it right first, then start on the process of getting the show (and the venue) varianced.

    I'm really surprised that you are getting the run-around like this. Ask your CDRH rep how other manufacturers get their projectors certified. And don't let him tell you that they all buy certified components. Everyone buys OEM parts these days (or worse, used parts off E-bay), so the bulk of the lasers purchased for laser show use will lack a CDRH certificate. (That doesn't mean that they are incapable of being certified, just that the manufacturer hasn't gone through the trouble.) At a minimum, if there is a shutter, a keyswitch, a power on delay, an emmission indicator, and a case interlock, along with proper labeling, you should be fine as far as the laser goes. (Read the specs that the CDRH publishes on their website for the details...)

    Adam

  5. #5
    Join Date
    Sep 2006
    Location
    OH, USA
    Posts
    114

    Default

    So I just got off the phone with the CDRH guy (Manual Karos); was kind of oppressive when he heard I was trying to start out, but I guess from his position it's his job to push it. He pretty much confirmed what you said, Buffo, about being able to add all the stuff myself, though he still seemed to discourage OEM's just because of the large amount of hassle that needs to be worked through.

    He also mentioned something problematic, kind of a Catch-22, where he was saying that when they are looking over the personal variance application, they want to see professional light show experience of some sort, which obviously you wouldn't have if you didn't have a personal variance. I'm going to try and solve this by getting some experience under another laser show company in Connecticut, owned by a guy who's been helping guide me a bit in this direction. I have yet to ask him but at least it will be something I can put on my application.

    I'll continue looking for certified lasers (if anyone knows of any 500mw-1w let me know), but if I can't find anything I might just go with OEM. Technically, without a laser light show variance, a company can not sell a certified laser to me, so it may be easier for me to get building now, and then have it certified once I get the experience and I have completed the basics of the projector.

    Buffo, by emission indicator, what is that? Is that a notice that indicates when the laser is on?

  6. #6
    Join Date
    Aug 2006
    Location
    North West England
    Posts
    1,148

    Default

    It's a LED indicator on the projector to show when it starts lasing.

    Jim

  7. #7
    Join Date
    Sep 2006
    Location
    OH, USA
    Posts
    114

    Default

    Ok no sweat, it sounds like most of that stuff can be solved by a simple microprocessor and a little bit of engineering.

  8. #8
    Join Date
    Jan 2006
    Location
    Charleston, SC
    Posts
    2,147,488,525

    Default

    You are over-engineering the solution. Forget the microprocessor. Put an indicator lamp (or better yet, an LED) in series with the keyswitch. When the switch is on, the light is on, and the laser is on. QED

    I agree that the guy is probably being a hard ass because he wants to discourage stupid behavior. However, if you do your homework, the next time you call him I bet he'll be more cooperative. Especially if you can hit him with things like:

    "According to 21 CFR 1040.10(f)(2)(i), Each laser product, regardless of its class, shall be provided with at least one safety interlock for each portion of the protective housing which is designed to be removed or displaced during operation or maintenance, if removal or displacement of the protective housing could permit, in the absence of such interlock(s), human access to laser or collateral radiation in excess of the accessible emission limit applicable under paragraph (f)(1) of this section." And then you say... "But since my projector doesn't have any parts of the case that are designed to be removed DURING OPERATION, does this mean that I don't need a case interlock?"

    Hint: The answer is not exactly cut-and-dry. If you need to use *tools* to open your case, and you never have a need to open the case while it's running at the venue - even to manually reset the remote interlock - then you don't need a case interlock switch. (The interlock is designed to protect the laserist and casual employees that might otherwise remove a panel to see what is inside, just for the hell of it.) The sticky part is the "maintenance" clause; that's a grey area... What activities, exactly, constitute maintenance? (As opposed to alignment - which obviously has to be done with the lasers running.) And if "maintenance" is only done by the person that built the projector in the first place, and has the tools to disassemble it correctly, then does he need to be protected by an interlock? (Here is the quandry....)

    I think you'll find that if you are already familiar with chapter and verse of the CDRH regs, they are more likely to talk to you about the specifics. But if you just call them up and say, "What do I need to do to make my projector legal?", then they're probably going to get all hard-ass on you.

    Adam

  9. #9
    Join Date
    Sep 2006
    Location
    OH, USA
    Posts
    114

    Default

    Well, I was thinking of using the microprocessor for not just the led, but interlock sets, and not being able to close the case while a defeated interlock exists or something. I'm not worrying about that for now, I know it'll be easy either way.

    I did probably just sound like some guy with a little tin box w/ mirrors and a laser wanting to get it legalized. I didn't say anything like that, but by the questions I was asking I'm sure he wasn't entirely impressed. Got to start somewhere though, right? heh

    I definitely think that bit of experience w/ that other laser show company could help; even if I just get to look inside their projectors and are shown their variance forms. Of course, they're dealing with bigger stuff than just a DPSS 1 watt module, but I suppose it is similar in principle. I have yet to hear back from the guy yet though. In the meantime, I'm foraging through all of the code on the CDRH website, and looking for an OEM laser so I don't need a variance just yet.

  10. #10
    Join Date
    Sep 2006
    Location
    OH, USA
    Posts
    114

    Default

    Well I just ordered my laser from Aixiz; at first I was a bit concerned considering the communication issues that have arisen with them, but they got back to me within 2 hours of the order. They mentioned that they come with most of the requirements of certification, but just aren't certified, so i'll have to do a little work but nothing huge.

    Also, I got the green light to go to Connecticut to observe some lasershow setups, so I get to do that sometime in the near future. Things are turning around I guess.

    And not that I'll need it with a 1 watt system, I also am in a deal to buy a hazer, in case the beam just isn't bright enough yet :P

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •