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This was just announced today.
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https://www.fda.gov/MedicalDevices/S...CampaignId=680
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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.
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~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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