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Thread: About Variance

  1. #1
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    Default About Variance

    Hello everybody,

    First of all,this is not a selling thread.

    These days,many of our friends and customers including Justin from Pangolin,asked us about Variance,they hear that we may lost our Varaince and worried about us.Thanks to these friends for caring about us.But,our Variance is still effective.

    We suspect that somebody is spreading rumor and doing bad competitions.Here I want to explian the policy about Variance:

    For importers in USA,they need to send a report to FDA and update their Vriance every year,but for exporters like us,we don't need to,our Variance is long term effective unless it being canceled.But we also need to send a report to FDA office to update our Accession number every year.

    Till now,we have not hear from the FDA office saying that our Variance has any problems.Attached is our newest Accession number which is valid to the end of 2015.

    The one who is spreading roorback,please stop!

    Hope all the best.
    Click image for larger version. 

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  2. #2
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    Quote Originally Posted by entertainment View Post
    Hello everybody,

    First of all,this is not a selling thread.

    These days,many of our friends and customers including Justin from Pangolin,asked us about Variance,they hear that we may lost our Varaince and worried about us.Thanks to these friends for caring about us.But,our Variance is still effective.

    We suspect that somebody is spreading rumor and doing bad competitions.Here I want to explian the policy about Variance:

    For importers in USA,they need to send a report to FDA and update their Vriance every year,but for exporters like us,we don't need to,our Variance is long term effective unless it being canceled.But we also need to send a report to FDA office to update our Accession number every year.

    Till now,we have not hear from the FDA office saying that our Variance has any problems.Attached is our newest Accession number which is valid to the end of 2015.

    The one who is spreading roorback,please stop!

    Hope all the best.
    Click image for larger version. 

Name:	Accession number.jpg 
Views:	46 
Size:	142.7 KB 
ID:	47855
    that's good to know! thank you for being legal.
    suppose you're thinkin' about a plate o' shrimp. Suddenly someone'll say, like, plate, or shrimp, or plate o' shrimp out of the blue, no explanation. No point in lookin' for one, either. It's all part of a cosmic unconciousness.

  3. #3
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    Quote Originally Posted by swamidog View Post
    that's good to know! thank you for being legal.
    You are welcome,it is our pleasure and duty.

  4. #4
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    @ The one who is spreading roorback,please stop!

    Click image for larger version. 

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ID:	47860 Come on Kang..... own up! Click image for larger version. 

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    Cheers

  5. #5
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    Thank you catalanjo,no matter you are kinding or serious.

    I think thoes one who is doing bad competition and spreading roorbacks will finally be nailed and loose his reputation.

  6. #6
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    Hello ABLE, aka 'entertainment' -

    Kudos to your efforts to 'take the high road', and do things correctly / safely, for Products introduced into Our (US) Commerce. We appreciate that - even though your products represent a source of stiff-competition to us US Manufacturers - at the very least, we appreciate Your apparent commitment to introducing safe and compliant Products, unlike some other Co's / products we have seen (unfortunately) make it thru customs, into this Country..

    However, I need to point out something that needs correction, here, and also a bit of 'advice'...

    Quote Originally Posted by entertainment View Post
    For importers in USA,they need to send a report to FDA and update their Vriance every year,but for exporters like us,we don't need to,our Variance is long term effective unless it being canceled.But we also need to send a report to FDA office to update our Accession number every year.
    I'm sorry, but unless there is something seriously 'lost in translation', here, this statement contains incorrect information. Your Co's Variance, which can be found here: http://www.regulations.gov/#!documen...09-V-0307-0003 ..Does not include any such 'exceptions' to the Rule / Requirement, for both Show AND Projector Manufacturers - that introduce them into US Commerce (sell / perform them here..) *regardless* whether they are US-based, or not - to File the Annual Report, containing the relevant-info they request / require of Manufacturers to-report, in order to maintain the Variance's 'renewed' / valid-status. There is no such thing as a 'long term effective' Variance anymore.. IF you don't file an Annual Report about your Products - every year, as-required - Your Variance expires at the end of that Year, and is No longer considered Valid.

    Now, that's NOT to say that your Projectors / Products suddenly become 'non-Compliant' - a Safe projector does not suddenly become UNsafe, simply because it's no longer under a valid / current Variance, ie: Mobolazer ML-10s, Laser Media tables, Image Engineering tables, and so-on.. but IF your Variance Expires because you / someone 'forgot to send in the Annual Report' - and is, therefore, No Longer Valid - you are not supposed to be Selling them, under these Conditions (expired Variance) and your dealers / distributors, if they continue to import / sell, are also 'breaking the law', at that point..

    ..I am NOT saying / accusing that 'ABLE' is doing this, simply that, it is NOT CORRECT to say 'Able does not need to do "this" (file an Annual report, Every year..) because of some 'long term effective' Variance, nope, Incorrect. If I am wrong - and ABLE somehow has some 'magic exception' - please point this out to me / us in your Variance Approval letter, or, in any of the other Publically-available Docs in your 'Docket Folder' - http://www.regulations.gov/#!docketD...DA-2009-V-0307

    Quote Originally Posted by entertainment View Post
    Till now,we have not hear from the FDA office saying that our Variance has any problems.
    ..And you Won't - at least not from it 'lapsing' / expiring, due to an Annual Report not being filed, within the year in-question.. They state that up-front. The ONLY reason, otherwise, they would contact you about a 'problem', is if a Complaint were filed with them, clearly-involving one of ABLE's projectors, and/or it was proven that some 'safety-aspect' of ABLEs projectors were, indeed, 'failing' / becoming un-safe (ie: shutters failing or electronics causing unwanted Class IV beams to shoot out when not-wanted, etc..) and there needed to be a 'Recall' (ie: what we saw happen with 'Laserworld' a few years back..) - THOSE are reasons why you would 'hear from the FDA'..

    ..So, if you fail to send in the Annual Report, your Variance will and does 'Expire' / lapse - which IS correctable, as long as you 'get on it', asap, AND the FDA subsequently acknowledges the submission / issues a Letter stating 'ok, it's Renewed until 12/31/XX'...

    Lastly, the 'advice'.. Looking at your Variance App, here: http://www.regulations.gov/#!documen...09-V-0307-0001 ..It only looks that you Filed with 3 'wavelengths' (which, back when you Filed, sure, those 3 lines were all that was 'practically' available for light-show use, shy of *extremely expensive* scientific SHG'd lasers / fiber-lasers, etc..) so, therefore, that's all you're *technically* allowed to be producing systems using.. In other words - Technically - you would be 'non-Compliant' with your Own Variance - in producing / selling Projectors using anything BUT those 3 listed / applied-for / Approved wavelengths..

    ..And - it appears - you've not 'Amended' your Variance, since the initial-filing.. (and, I am allowing for the entirely-realistic possibility, that the FDA has simply not Updated your Docket folder on Regs.gov with any 'Amendments' you may have since-filed, although, they' are getting pretty-good at keeping things updated, these days..) So.. IF you have NOT Filed an 'Amendment' - and, usually they would have a) an Acknowledgement Letter of your Amendment-submission, b) the Amended Variance App, and c) The Approval Letter (if-granted..) ALL IN that 'Docket' folder, if you Had - You really should.

    ..And, make the amendment rather 'broad', ie: Instead of submitting ONLY 635nm for Red, submit '607nm - 670nm' - Cover the whole gamut! Same for Green.. 500nm (who knows?! on up to 555nm, etc.. And Blue, 405nm, on up to 480nm, etc.. Really you can simply list '400-700nm' - and they are Fine with that - since that is NOT within any of the 'prohibited wavelengths' ("invisible") etc..

    Maybe you / some think this is 'no big deal' but.. That's the way these Variances are 'interpreted' by the CDRH - If you are 'super-specific', then THAT'S ALL YOU ACTUALLY GET APPROVED.. ie: You - as listed currently / publically - have Approval for 635, 532, and 473 - but Not for 520, 637, or 445 / 462, make sense?.. Again, yes, 'technically' - but that's pretty-much what 'Compliance' is all about - those 'technicalities'..

    For what it's worth.. Keep up the good work / Prices higher!
    j
    Last edited by dsli_jon; 07-24-2015 at 03:27. Reason: fix copy
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  7. #7
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    Thanks for your suggestions,but I think I made the policy about Variance clear enough,we also need to make and send annual report,but not to update Variance number,accession number instead.

  8. #8
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    Quote Originally Posted by entertainment View Post
    Thanks for your suggestions, but..
    No, there is no 'but's, here.. If you are producing / selling Products, with attributes that are NOT listed in your Variance App, you are Non-Compliant, that's It! There's no 'but'.. Please take these kind suggestions - not just to 'say thanks', but take them to Pen and Ink! - and Update / Amend your Variance App, with what you are (currently) selling. That's what you Need to do, if you - as a Foreign Manufacturer, selling / Exporting your Products into Our Country - wish to remain Compliant with your Variance, ok? If you wish, I will ask the CDRH to explain this to you, but I am hopeful we can simply find a way to help you Understand, right here in PL.. Let me know if you wish for more explanation.

    Quote Originally Posted by entertainment View Post
    ...I think I made the policy about Variance clear enough, we also need to make and send annual report,but not to update Variance number,accession number instead.
    Again, I am allowing for the 'losses in translation', here, for which I Apologize that I have not taken it upon myself to learn Your language, yet, but.. I think you don't Understand the 'policy about your Variance'.. a) You don't submit the Annual report to 'update your Accession Number' - all that 'number is' is like a 'Filing number', or, a 'Reciept number' - It is Meaningless, as-to the *validity* of your Variance-status.. What 'counts' is the Approval Letter, stating that 'ok, we got / filed your Annual Report, don't see any issues, are-renewing your Variance untill X/XX... THAT's what matters..

    ..SO, AS LONG AS you keep sending in your Manufacturer's Annual Report, AND, keep up with the Reporting-requirements, within (How many Produced / Introduced into US commerce, any 'recalls' / advisories, etc, etc) AND the CDRH accepts / Sends you a renewal Letter - your Variance is Valid. Otherwise, it is simply Incorrect for you to state 'oh, we don't have to do that, Our Variance is 'long term approved', Nope, incorrect.

    Just - kindly / friendily - pointing that out..

    J
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  9. #9
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    Thank you,actually,I can not understand your long artical very much,can you add my skype or face book so that we can talk more efficient?
    My skype name is salvalos

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