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Thread: X-Laser's New Variance Process

  1. #21
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    just for clarification: DIYers are doomed. It just sucks to me, being that it's possible in other civilized countries, that a person in the US can't design and build a system with their own innovations and design frills along with the required safety features that the CDRH requires unless they dedicate years of their live just to waiting... and waiting and waiting. People could be making money and demonstrating their talents, but instead they wait their asses off. And once you've got that projector done and approved, if you make a new design you've got to start the whole process again. It seems like people are being steered into buying specific pre-approved items because they're pre-approved, but to me that takes a lot of my participation in the design and eliminates it.. not to mention no one will ever get me for $2,000+ for an empty case with some interlocks when I could build it myself with only the features I need (optical table not required, etc..) and the required gov't stuff. I'm not looking to be outright robbed today, thanks.

    Now, I'm not a veteran of the CDRH process, all I know is what I've found out trying to figure it all out.. but it seems like to do what I would like to do will be a nightmare.. but the wheels are already grinding. I'll get there someday for sure.

  2. #22
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    Quote Originally Posted by ElektroFreak View Post
    just for clarification: DIYers are doomed. It just sucks to me, being that it's possible in other civilized countries, that a person in the US can't design and build a system with their own innovations and design frills along with the required safety features that the CDRH requires unless they dedicate years of their live just to waiting... and waiting and waiting. People could be making money and demonstrating their talents, but instead they wait their asses off. And once you've got that projector done and approved, if you make a new design you've got to start the whole process again. It seems like people are being steered into buying specific pre-approved items because they're pre-approved, but to me that takes a lot of my participation in the design and eliminates it.. not to mention no one will ever get me for $2,000+ for an empty case with some interlocks when I could build it myself with only the features I need (optical table not required, etc..) and the required gov't stuff. I'm not looking to be outright robbed today, thanks.

    Now, I'm not a veteran of the CDRH process, all I know is what I've found out trying to figure it all out.. but it seems like to do what I would like to do will be a nightmare.. but the wheels are already grinding. I'll get there someday for sure.
    after you submit all the paperwork you technically dont have to wait to get the actual variance back before doing shows after a certain amount of time has elapsed IIRC

    could be wrong though

  3. #23
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    Haven't been able to find a definite answer to that either.. I'm just impatient. I know that it can be done, it's just frustrating.

  4. #24
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    EF-

    as bitter as i am to all of this, it isnt as bad as youre making it out to be.

    This is technically a "self certifying" profession. In other words, you can make your laser in a toaster over with 500 watts of IR leakage and a cardboard optical table and get an accession # from your product report. At this point, in the eyes of the CDRH, you are using a compliant projector. (obviously in your report, you wouldnat have said you made all of those bonehead designs). This is why all of these chinese companies that say FDA comliant are full of poopie. Anyone can submit a report for anything and make it look good and get an accession # for it. an accession # is NOT an approval.

    Now, on the "approval" term. Product reports are no longer "approved." you submit your report, tell them how you designed and built your system, and it is your responsibility to make sure the projector is built to those specifications in your report.

    As long as you build your system with the required safety features, CDRH will have no objections and you will never hear from them again.

    Once you submit your paperwork, and get you ack letter and/or accession # you're good to go.

    Casey Stack confirmed the above statememt at SELEM also!

    -Marc
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  5. #25
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    Quote Originally Posted by gottaluvlasers View Post
    toaster over with 500 watts of IR leakage and a cardboard optical table
    mmm IR toaster... would probably make good grilled cheese

  6. #26
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    Quote Originally Posted by gottaluvlasers View Post
    EF-

    as bitter as i am to all of this, it isnt as bad as youre making it out to be.

    This is technically a "self certifying" profession. In other words, you can make your laser in a toaster over with 500 watts of IR leakage and a cardboard optical table and get an accession # from your product report. At this point, in the eyes of the CDRH, you are using a compliant projector. (obviously in your report, you wouldnat have said you made all of those bonehead designs). This is why all of these chinese companies that say FDA comliant are full of poopie. Anyone can submit a report for anything and make it look good and get an accession # for it. an accession # is NOT an approval.

    Now, on the "approval" term. Product reports are no longer "approved." you submit your report, tell them how you designed and built your system, and it is your responsibility to make sure the projector is built to those specifications in your report.

    As long as you build your system with the required safety features, CDRH will have no objections and you will never hear from them again.

    Once you submit your paperwork, and get you ack letter and/or accession # you're good to go.

    Casey Stack confirmed the above statememt at SELEM also!

    -Marc
    Too bad I wasn't at SELEM.. I have been under the impression (just from reading the regs and talking to various people) that I would have to basically ship my projectors off to the CDRH so that they can check them out and let me know if it's all good, UNLESS I use a ready-made system or a "pre-approved" enclosure like OSLS sells for an arm and a leg.. As I've said, I haven't yet applied for certification, but now that I have this info I will be very soon. Perhaps I've been getting a bunch of bad or outdated information.. wouldn't surprise me. If all I need to do is ensure that my i's are dotted and t's crossed with my design and then submit paperwork that's some of the best news I've heard yet.. and no one that I've talked to has been good enough to share it with me in plain terms until you did just now. Based on the CDRH regulations it seems like it would be that simple, but I've always been told to expect nightmares. We'll see how bad (if at all) it really is these days.

  7. #27
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    Quote Originally Posted by ElektroFreak View Post
    Too bad I wasn't at SELEM.. I have been under the impression (just from reading the regs and talking to various people) that I would have to basically ship my projectors off to the CDRH so that they can check them out and let me know if it's all good, UNLESS I use a ready-made system or a "pre-approved" enclosure like OSLS sells for an arm and a leg.. As I've said, I haven't yet applied for certification, but now that I have this info I will be very soon. Perhaps I've been getting a bunch of bad or outdated information.. wouldn't surprise me. If all I need to do is ensure that my i's are dotted and t's crossed with my design and then submit paperwork that's some of the best news I've heard yet.. and no one that I've talked to has been good enough to share it with me in plain terms until you did just now. Based on the CDRH regulations it seems like it would be that simple, but I've always been told to expect nightmares. We'll see how bad (if at all) it really is these days.
    lol no you don't have to ship anything to the CDRH except paperwork...

    basically the main issue the turnaround time

  8. #28
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    I'm not at all surprised to hear that I've been steered wrong about this. It's in some people's perceived best interest to keep this kind of information away from others if possible.. whether it's by being silent or by spreading disinformation. I guess I should have taken the information in the regs themselves verbatim, because when I look at them directly the impression I get fits with Marc's post above.. but the sporadic information I've received from others has been slightly different. Take the OSLS case for example.. I was pretty much told a couple different times that the reason those exist is because it's such a terrible pain waiting for the CDRH to physically inspect your design.. and that's IF they accept it after the "inspection". Obviously I was told this by douchebags. Nice.

    Thanks to both of you (Marc and Flecom) for helping inject some reality into my apparent delusions. And I'd also like to extend a hearty "Fuck You" to every person that I've asked or conversed with about this that led me to believe otherwise.

    I've had so many different things thrown at me regarding this mess that I really have no idea what's right or wrong myself.. getting a clue now thanks to you guys though.

  9. #29
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    Marc,

    I think I need to interject and respectfully disagree.

    When you file a product report with CDRH you get an accession number back regardless of the content of the report. True.

    You do not have to send your projector to a lab *but* all certifications are based upon tests and data regarding components and features used to make the projector. Larger companies tend to send units to optics labs to get the tests done especially in cases where class is at issue. However there is nothing to say that those tests cannot be performed in house. True.

    Here's the part where I disagree:

    The CDRH does approve product reports as far as I know because when the report is submitted it has to be evaluated and then a letter is generated back to the manufacturer saying that the *submission* is approved and that the product may now be entered into US commerce. What I believe Casey was saying was that the CDRH does not approve the projector, however they still have to approve or disapprove the mechanisms which you have used to established satisfactory radiation controls. I got an approval just a few weeks ago and we could not sell the unit until we had that in hand.

    Without the CDRH approving product reports there would be nothing to stop the Class IV toaster laser with emission indicator and key switch from making an appearance at your local music store. Casey is in China but I will touch base with him when he gets back to see if I have misunderstood... but as I said, I got an approved report within the last month.

  10. #30
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    Quote Originally Posted by ElektroFreak View Post
    I've had so many different things thrown at me regarding this mess that I really have no idea what's right or wrong myself.. getting a clue now thanks to you guys though.
    dont worry, your not alone, thats why I just gave in and bought the OSLS enclosure... its actually really nice

    Quote Originally Posted by X-Laser View Post
    we could not sell the unit until we had that in hand.
    from my understanding somewhere, something, says that the FDA cannot impede commerce or something like that... so after waiting a certain magical period of time (I have heard 90 days several times) you can do shows with your accession number even though you have not received an actual variance back from the CDRH

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