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Thread: Laser Show Variance Refs/Agency Contacts

  1. #1
    Join Date
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    Smile Laser Show Variance Refs/Agency Contacts

    ...see post below for new-info 'bump'...
    Last edited by dsli_jon; 04-26-2010 at 21:36.
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  2. #2
    Join Date
    Nov 2007
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    SoCal / San Salvador / NY
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    Lightbulb Current, as-of 4/25/10 - please correct / update as you discover... thx

    Quote Originally Posted by DZ View Post
    This is all fantastic information to have quick access too. Can this be "pinned" at the top of this forum so it doesn't get lost...
    This is the re-post, by 'request' -

    Hey Cats - Ok, here is most recent version of 'the Bible': (uh, US-version, that is!

    A pretty-good (not always up-to-date, but about 80-90% there - gets you in the right direction anyway) resource for State Regs and Contacts http://www.rli.com/resources/statecontacts.aspx - (ie; CT requires "Written notification as required by FDA" , which more or less is just a 'courtesy notice' - nothing hardcore
    like NY or AZ reqs...

    And most-current address for all existing Variance-holders' Show Reports for CDRH should go to:

    Center for Devices & Radiological Health
    L. Dale Smith, CSO, Office of Communication, Education, and Radiation Programs (HFZ-240)
    10903 New Hampshire Avenue
    Silver Spring, MD 20993
    FAX 240/ 276-3272

    ..You can contact Dale Smith, directly: 301-796-5868, lds@cdrh.fda.gov and Dan Hewett 301-796-5864, daniel.hewett@fda.hhs.gov, or Patrick Hintz 301-796-6927 patrick.hintz@fda.hhs.gov, or Woody Strzelecki 301-796-6939 Woody.Strzelecki@fda.hhs.gov, -but it appears that Dale or Woody would be your best 'first contacts', since they are most 'directly active' on laser show reporting / questions, etc...

    Annual / Product Reports (for those with current variances, via 'snail-mail'..) to:

    U.S. Food and Drug Administration
    Center for Devices and Radiological Health
    Document Mail Center WO66-G609
    10903 New Hampshire Avenue
    Silver Spring, MD 20993-0002

    Original Variance requests, to:

    Food and Drug Administration
    Division of Dockets Management (HFA-305)
    5630 Fishers Lane, Room 1061
    Rockville, MD 20857

    Most current info they have on the web is here:
    http://www.fda.gov/Radiation-Emittin.../ucm118122.htm (repository of all docs...)

    http://www.fda.gov/Radiation-Emittin.../ucm118907.htm (laser-show specific...)

    ..specifically, this PDF is helpful (as a 'summary' of the regs, etc...)
    http://www.fda.gov/downloads/Medical.../UCM119257.pdf

    And FAA's most current regs-info is here:
    http://www.faa.gov/about/office_org/...e_rules/laser/

    Also, here is some good general safety articles from ILDA (though some of it is dated, but still fairly-relevant..): http://www.laserist.org/Laserist/Safety.html

    PM-me if you ever need any help on Variance prep/FAA prep/Regional Contacts info...I will be glad to help as much as I can, on an 'as-available' basis...

    peace...
    - j
    Last edited by dsli_jon; 10-21-2010 at 10:39.
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

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