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Thread: FDA Crackdown?

  1. #41
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    Quote Originally Posted by buffo View Post
    I hereby invoke Goodwin's law. Train of thought derailed.

    Adam
    Nice.
    Quis custodiet ipsos custodies?
    Solid State Builders Group

  2. #42
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    Here's an interesting tidbit that's on the Laser Compliance site:

    "OEM products may not be sold to end users."

  3. #43
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    Thats taken care of in the sale warning/agreement, as in ...
    - This module is not a toy. It can be used in different fields, such as: manufacture uses, stage light, scientific research institutions, clubs labs and so on.
    - This laser module is sold as a component for manufacturing and should not be construed as a finished system.
    - Don’t use this module to make an illegal device.
    - Users assume all liability for use or misuse of this module.
    - If you decide to purchase this laser, it means that you agree to and accept all this agreement
    Quis custodiet ipsos custodies?
    Solid State Builders Group

  4. #44
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    Thumbs down

    Stop giving legal advice, Alec. You clearly don't know what you're talking about.

    You can't violate CDRH requirements by adding a "Sale/warning agreement". Fool! That's what got the guy on LPF in trouble.

    Adam

  5. #45
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
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    [QUOTE=keeperx;95272]Thats taken care of in the sale warning/agreement, as in ...
    - This module is not a toy. It can be used in different fields, such as:




    Keeperx,


    "OEM products may not be sold to end users."

    Boy, you have no idea how FDA, EPA, FCC, CPSC, NRC, BATF, FAA , NTSB, DOT, and the other technical regulators can operate. Civil and Criminal procedure comes after they string you up and stop your day to day operations and freeze your accounts. YOU DO NOT GET A DAY IN COURT WHEN THIS HAPPENS< THERE IS NO HEARING TO SET THE LEVEL OF THE FINE.

    Civil law law drops out and there is another playbook called a notice of apparent liability. You don't get a day in court, you just get a letter saying you have been found at fault, and now you owe a fine, payable usually to Mellon Bank, Pittsburgh Branch, US Treasury Account # ........
    And if a fine doesnt get your attention, its usually a slam dunk open and shut case for a US Attorney.

    TECHNICAL LAW is much, much different from normal day to day business operations. When you do something technical, you are often in the public's trust, and held to a much higher standard.

    DONT GIVE ANY MORE OF YOUR SO CALLED ADVICE in tHESE MATTERS. YOU DONT HOLD A VARIANCE< YOU DONT RUN A LAB< AND YOU HAVE NO IDEA WHAT THE HELL YOU ARE TALKING ABOUT> THIS IS NOT BASIC CONSTITUTIONAL LAW< AND ITS A AREA MOST LAWYERS DONT HAVE A CLUE ABOUT>

    Steve
    Last edited by mixedgas; 05-08-2009 at 06:54.
    Qui habet Christos, habet Vitam!
    I should have rented the space under my name for advertising.
    When I still could have...

  6. #46
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    Quote Originally Posted by mixedgas View Post
    Too bad we cant get their "frothychimp" guy to ome over here, since he just quit over there. Looks like another grad student or engineer who knows his stuff.

    Steve

    Yeah he has 4 degrees, one is in neuroscience I think he works for OEM laser systems, so he uses lasers every day. He really does know his stuff when it comes to laser safety and laser radiation related laws !

    -Adam

  7. #47
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    Quote Originally Posted by buffo View Post
    I hereby invoke Goodwin's law. Train of thought derailed.

    Pat;

    I agree that you are under-appreciated over there. Honestly I don't know why you keep going back. With the enormous collection of fools they have, I would have thought you would be sick and tired of it by now.

    Nonetheless, we certainly appreciate your presence here. (And if you can get "frothy-chimp" to join PL, so much the better!) For the record, I thought your advice was right on the money. Pity that more people don't listen...

    Adam
    Goodwins law - absolutely amazing!

    I dont need strokes of ego, it is already too big. I have always enjoyed teaching and this is a subject I feel I know a little bit about. FIRST HAND, not book smart so much but paid my dues smart. I got lucky many times and rode a big wave at the right time, had energy to innovate, and unstoppable optimism. Many over there are smart "youth" and I would love to help. My only goal was education beyond the relm of popping balloons and lighting matches that some might decide to get educated.

    Thanks for your kind words, I like it here too and the collective knowledge base is truely overwelming. Old School ive got down, I wish I had 1% the knowledge you guys have on everything post 1995, when my brain sort of short circuited. (the YAG years)
    Pat B

    laserman532 on ebay

    Been there, done that, got the t-shirt & selling it in a garage sale.

  8. #48
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
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    You might find this interesting:

    http://www.laserpointersafety.com/LP...AS_cleared.ppt

    Steve
    Qui habet Christos, habet Vitam!
    I should have rented the space under my name for advertising.
    When I still could have...

  9. #49
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    Quote Originally Posted by mixedgas View Post
    You might find this interesting:

    http://www.laserpointersafety.com/LP...AS_cleared.ppt

    Steve
    very informational!!

    But I would sure like to have a laser with that tight of a beam at that distance!,
    referring to the cockpit pictures
    I know who they are talking about in vegas.....

  10. #50
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    Quote Originally Posted by Lasernerd View Post
    very informational!!

    But I would sure like to have a laser with that tight of a beam at that distance!,
    referring to the cockpit pictures
    I know who they are talking about in vegas.....
    not too smart there grasshopper...can you say subpoena?

    PS I wonder where those guys got those big green lasers at the hilton>
    Pat B

    laserman532 on ebay

    Been there, done that, got the t-shirt & selling it in a garage sale.

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