Re: FDA Exemption

[roseb@SMTP-gw.gdls.com (Boyd H Rose)]

     Donald,
     
     I recently had to research a military exempt laser system which is 
     installed by General Dynamics (GDLS) to the M1 Abrams Tank System.  I had 
     similar questions about the FDA requirements for such lasers and how GDLS 
     would be affected.
     
     Take a look at MIL-STD-1425A,Safety Design Requirements for Military
     Lasers and Associated Support Equipment (1991), and SECNAV INSTRUCTION
     5100.14B.  These document are available in HTML and/or MS Word format at
     
        http://safety.nswc.navy.mil/las_saf/MS1425a.htm
     
        and
     
        http://safety.nswc.navy.mil/las_saf/SECNAV5100-14B.htm
     
     LMMS' "exemption" from the FDA requirements is given in 21 CFR Chapter I, 
     Subpart J, Part 1040, Performance Standards for Light Emitting Products 
     (1997).  The exemption is granted when LMMS produces the laser system in 
     accordance with the Navy's contract specification and requirements for the 
     military exempt laser system.
     
     Also, http://safety.nswc.navy.mil/las_saf/index.htm is the U.S. Navy Laser 
     Safety Homepage which gives an overview of the Navy's laser safety program 
     and requirements.  Rockwell Laser Industries has a great homepage at 
     http://www.rli.com/ which has some interesting links which may help you.
     
     I hope this helps.  Success in finding the answers you need!
     
     Boyd H. Rose, CM
     Radiation Protection Officer
     General Dynamics Land Systems Division
     roseb@gdls.com
     
     The opinions expressed above are solely my own and do not under any 
     circumstance reflect those of my employer.


______________________________ Reply Separator _________________________________
Subject: FDA Exemption
Author:  radsafe@romulus.ehs.uiuc.edu at Internet/Unix
Date:    11/10/97 12:25 PM


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Good Monday, HPs et. al.
     
Do any of you have any documentation exempting the Navy/Air Force/DOD 
from FDA requirements for laser systems? Specifically, LMMS is going to 
sell a laser system to the Navy, and I was trying to find out if we, the 
manufacturers of the system, had to make sure it complied with FDA 
requirements. I contacted the FDA and they indicated that "there should 
be a letter" of exemption. I don't know what the letter would say, but I 
would think LMMS should have a letter saying *we* are exempt, not the 
Navy.
     
Anybody familiar with the situation?
     
Thanks in advance.
     
     
     
Donald P. Mercado
Radiation Safety Officer
Lockheed Martin Missiles & Space
O/47-20, B/101
1111 Lockheed Martin Way
Sunnyvale, CA 94089
Ph. (408) 742-0759
Fx. (408) 742-0611
Email: Don.Mercado@lmco.com
     
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Message-ID: <BD6E8EB53D9AD011AB860000F81E49C6020F0803@emss01m04.ems.lmco.com> 
From: "Jones, Sandy" <sandy.jones@lmco.com>
To: "Mercado, Don" <don.mercado@lmco.com> 
Subject: FW: Friday-itis....
Date: Mon, 10 Nov 1997 07:54:52 -0800 
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----------
From:   Munoz, Terri M
Sent:   Friday, November 07, 1997 4:23 PM 
To:     48-10 CSS Group
Subject:        Friday-itis....
     
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         @\|/@       
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"What is the meaning of life?"
"All evidence to date suggests it's chocolate."
     
     
     
     
     
     
     
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