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Thread: Warning! FDA

  1. #1
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    Default Warning! FDA

    Just got this email from the ILDA laser group. This is a warning about the FDA.

    FYI after talking to the FDA folks for a carrier it seems that the FDA/CDRH is pulling for inspection anything tagged "laser" from China to the USA.

    They are busting a lot of items right now - just heard about 2000 pens with lasers in them which were caught a few days ago.

    This means laser on the commercial invoice or laser in the name of the company shipping it.

    So, a word to the wise - have your accession # information from your overseas supplier. This includes OEM parts since the CDRH now has a submission report for those as well.

    Chuck - AixiZ
    Dunno is that counts for exports, but if it does, that could cause major problems.
    CLICKY!!!

    Admin: In the immortal words of Captain Planet: YOU HAVE THE POWER
    Admin: (To quit being a bitch)

  2. #2
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    Cool

    i just read about this on lasercommunity.com

    FDA / CDRH are mainly concern with the large number of imported lasers coming especially from china
    MY LASER PROJECTOR IS PREGNANT, I GOT A BUNCH OF KIDS COMING FROM OVER SEAS

  3. #3
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    Default

    it is not good news for us.

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    Cool

    Well, it might be time to think about applying for an assession number for your lasers, Bridge. You'd need to fill out a laser product report and send it to the CDRH.

    Since you're selling OEM products, a lot of the extra requirements don't apply to you. (In fact, I'm not even sure that an OEM part requires a mechanical shutter anymore. Might want to check with the CDRH on that to be sure though.)

    Basically the whole point of the laser product report is to make sure your laser has the proper labels, an emmission indicator, and so on... Then they (the CDRH) have a reference to that laser when someone decides to incorporate one of them into their own product.

    Adam

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    thanks Adam,
    you know all the things, just like encyclopedia.
    ok, where I can find the CDRH? I must read and understand it first.
    Thanks.
    Best regards!
    Bridge

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    If the FDA is clamping down, everybody better buy their lasers thru Aixiz
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  7. #7
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    clandestiny is offline Eleventy-Billion Watt Ar/Kr >:)
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    Default

    Yes, the word went out, the inital busts netted the feds several thousands of illegal pointers-
    It will probably expand to oem diodes as well-

    American companies developing out of china for import to the U.S. are aware of this-
    and they have their documentation in order
    Asian companies selling to the U.S. will have to brace for impact-

    Interestingly, if you need to send a diode unit back to china for repair- and its not of the approved variety,you may loose it on the way back. This will compound the woes of having a unit quit on you..

    Or you could just give up and join me in ion land utopia
    go big or go home

  8. #8
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    Smile

    Quote Originally Posted by bridge View Post
    ok, where I can find the CDRH? I must read and understand it first.
    Hi Bridge;

    The best place to start would probably be with the relevant federal standard, which in this case is 21 CFR 1040.10 and 21 CFR 1040.11. Of the two, the 1040.10 standard is the one that has the most detail, and will be the one that will be most difficult for you to decipher. Read through that standard *very* carefully, and you should be able to figure out if you can make your lasers compliant with the standard.

    Once you are sure that your lasers meet the requirements of the standards above, you will need to file a Laser Product Report with the CDRH. They have a guide that will help you prepare this report. Submit the report to the CDRH, and if they approve it they will issue you an accession number which will then allow you to legally export your lasers to the US.

    Having this number will also prevent the problems listed above with lasers being held up (or worse, seized) by US customs officials.

    See this list of frequently asked questions on the CDRH website to get an overview of what is required.
    Quote Originally Posted by dave View Post
    If the FDA is clamping down, everybody better buy their lasers thru Aixiz
    I don't know about that David... Aixiz doesn't have the best reputation! Plus, they're just a re-seller. They still need to import their lasers from China as well. If US customs officials are stopping the lasers at the border, there's not much that Aixiz can do about it.

    Actually, I'm wondering how this will affect your exports to the US... Do you ship from Australia, or do you drop-ship direct from the Chinese supplier?
    Quote Originally Posted by clandestiny View Post
    Or you could just give up and join me in ion land utopia
    Give it up, Paul! No one is going to join you in the land of heavy, fragile lasers that mix water cooling with tens of amps of high voltage DC all in a glass package! (Sounds like a good way to electrocute yourself...)

    Besides, even if I could afford one of your ion lasers, I'd never be able to afford to rent the 3 Phase generator I'd need to power it with. (Not to mention the FORKLIFT I'd have to buy so I'd have a way to move it!)

    Ok - I'll admit that I'm still envious of your ion beauties - even with all their drawbacks. But I'd get a hernia for sure trying to lift one of those big PSU's. Besides - I damn near killed myself with the 110V power I had on my Alphalite-based projector. How long do you think I'd survive if I had a big honkin' Ion laser to play with. (And no, my HGM5 hasn't shocked me - yet!) And how much was your electric bill last month, anyway?

    Just playin' the devil's advocate here, buddy...

    Adam

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    Lightbulb

    Quote Originally Posted by clandestiny View Post
    This will compound the woes of having a unit quit on you..

    Or you could just give up and join me in ion land utopia
    Hear! Hear!

    yes, the CDRH has apparently gotten a fresh-crop of new, and 'hungry' blood inside - anyone (with a CDRH Variance) gotten Laser Notice 55 yet?

    Basically, now you now don't have to renew every 2-years- as long as you FILE your Show reports, and subsequent ANNUAL report, every year, (and of course, have no incidents ie: bloody hitting Conan in the eye on national TV, etc... ) the Variance will 'auto-renew' at the end of the calendar year you've successfully filed your annual...

    Details here http://www.fda.gov/cdrh/ocer/guidance/1639.html

    RE: crackdown on projector imports - Good news in my book - this will cut down on all the 'rogue Laser DJs' doing exactly the kind of shyte Marc (gottaluvlasers) was rightfully venting about - any of the 'truly-Pro' systems coming out of Germany (ie Arctos), Hungary (ie RGB) or UK (ie Laser Quantum) will have DONE their OEM product accession # / certified projector, etc homework, so you should be good-to-go...

    But yeah, the OEM diode / DPSS hobbyist may find some frustrating times ahead...

    peace..

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

  10. #10
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    in my opinion

    i dont think the FDA is going to be targeting legit OEM laser *MODULE* manufacturers. (i.e.- CNI, Laserwave, Viasho, Lasever...etc...etc...).

    i think their main concern is going to be the "Wicked Lasers" type of manufacturers who are supplying EXTREMELY powerful (upwards of 1+WATT now!!!) handheld lasers. there is NO NEED, ABSOLUTELY NO NEED for a 1 WATT handheld laser. PERIOD!!! i dont care HOW you try to justify it. you dont need a 1W or hell, even a 300-400mW laser to "Star point!"

    Bridge- i know viasho has accession #'s with the FDA/CDRH (which i was VERY impressed with by the way!!). I would suggest you doing the same! You're company is DRASTICALLY becoming one of the leaders in the laser industry with an EXCELLENT reputation. i would (along with most everyone else) hate to see something stall your growth and shipments to us because of some paperwork.

    your lasers are VERY well made and i believe you already fullfill the requiremnts, so i dont believe it will be a burden at all for you to obtain an Accesion #.

    -Marc

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