Guidance on the Department of 
Defense Exemption from the 
FDA Performance Standard for 
Laser Products; Guidance for 
Industry and FDA 
 
(Laser Notice No. 52) 
 
 
 
 
 
 
 
 
 
Document issued on: July 12, 2002 
 
 
 
 
 
 
 
 
 
 
U.S. Department Of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
   
Electronic Product Devices Branch 
Division of Enforcement III 
Office of Compliance  Preface 
 
Public Comment 
 
Comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of 
Human Resources and Management Services, Food and Drug Administration, 5630 
Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting 
comments, please refer to the exact title of this guidance document.  Comments may not 
be acted upon by the Agency until the document is next revised or updated.   
 
For questions regarding the use or interpretation of this guidance contact Jerome E. Dennis at 
301-796-5710, or by electronic mail at mailto:jxd@cdrh.fda.gov. 
 
Additional Copies 
 
Additional copies are available from the Internet at:  
http://www.fda.gov/cdrh/comp/guidance/1412.html.Y  ou may also send an e-mail request 
to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request
to 301-847-8149 to receive a hard copy.  Please use the document number (1412) to identify 
the guidance you are requesting.
 
 
1  Guidance on the Department of Defense 
Exemption from the FDA Performance 
Standard for Laser Products (Laser 
Notice No. 52) 
 
 
This document is intended to provide guidance.  It represents the Agencys current 
thinking on this topic.  It does not create or confer any rights for or on any person 
and does not operate to bind the Food and Drug Administration (FDA) or the 
public.  An alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.  
 
 
Purpose 
This guidance clarifies and updates the conditions of FDA exemption no. 76EL-01DOD 
granted in 1976 to the U.S. Department of Defense (DoD) for laser products procured for 
combat or combat training or that are classified for reasons of national security.  This 
guidance supplements Laser Notice Nos. 9 and 15 and identifies the current resources in 
the military services for the administration of this exemption. 
 
Issue 
The U.S. Department of Defense established a joint services group, the Laser Systems 
Safety Working Group (LSSWG), to coordinate laser safety issues within the DoD.  The 
LSSWG requested FDA to reissue its earlier guidance to industry on the subject of the 
DoD exemption.  The LSSWG request was based on a concern that laser products not in 
compliance with the FDA standard are offered to various DoD purchasing authorities and 
procured without appropriate control measures implemented to assure the safest possible 
use. 
 
Background 
Laser products sold in or imported into the United States must comply with the Federal 
Performance Standard for Laser Products issued by the Food and Drug Administration 
(FDA), Center for Devices and Radiological Health (CDRH), in Title 21, Code of Federal 
Regulations, Subchapter J, Parts 1040.10 and 1040.111.  The Federal Laser Standards 
require laser products to incorporate certain safety features, which may include warning 
lights, warning labels, and housing interlocks. 
 
In 1976, the FDA Commissioner allowed the Department of Defense (DoD) or its 
components to exempt certain military laser products from the provisions of the Federal 
Laser Standard and associated reporting and recordkeeping requirements.  This 
exemption applies to DoD lasers used for actual combat or combat training or those 
                                                                 
1 See 21 CFR 1040.10 (a) for details on the applicability of the FDA standard and exceptions from 
applicability.  
2  classified in the interest of national security.  The exemption was granted with the 
following provisions: 
 
  Laser product specifications must include, to the extent practicable, the safety 
features required by the FDA standard; 
  Laser product specifications will be supplemented with safety controls specified 
by DoD; and 
  DoD exempted laser products will be clearly identified through labeling. 
 
An example of how the DoD exemption may be applied is to exempt a military laser 
product from the FDA requirements for laser radiation emission indicators and warning 
labels.  These visible or audible emission indicators and brightly-colored labeling are 
inappropriate for products intended for use in a combat environment where camouflage 
and concealment are necessary. 
 
The Least Burdensome Approach 
The issues identified in this guidance document represent those we believe need to be 
addressed before your product can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also considered 
the burden that may be incurred in your attempt to comply with the guidance and address 
the issues we have identified.  We believe that we have considered the least burdensome 
approach to resolving the issues presented in the guidance document.  If, however, you 
believe that there is a less burdensome way to address the issues, you should follow the 
procedures outlined in the A Suggested Approach to Resolving Least Burdensome 
Issues document.  It is available on our Center web page at: 
http://www.fda.gov/cdrh/modact/leastburdensome.html. 
 
Guidance 
The manufacturer must obtain an exemption letter from an authorized DoD procuring 
agency to allow the use of the DoD exemption for a specific product.  The manufacturer 
must obtain the DoD exemption letter prior to sale and retain it for subsequent sales to 
any DoD agency.  Any subsequent modification to a military exempt laser product by 
the manufacturer requires a new DoD exemption letter.  The DoD exemption letter may 
specify a number of units, an armed service, and/or a period of time.  
 
A manufacturer violates Federal law if it sells a laser system not in compliance with the 
FDA standard to the DoD or falsely labels a laser product as exempt without a written 
DoD exemption letter.  Several laser system manufacturers market laser products that are 
labeled as military exempt.  Many of these systems lack written documentation of DoD 
exemption.  An appropriate DoD laser safety representative must evaluate all military 
exempt laser products to determine compliance with relevant military or Federal 
requirements.  Manufacturers of military exempt laser products should not assume the 
DoD exemption applies to its product unless DoD provides an exemption letter. 
 
Once the DoD exemption is applied to a specific laser system, the system cannot be sold, 
surplused, or distributed to organizations outside the DoD, unless the laser system is 
3  brought into full compliance with the FDA standard, certified, and reported in accordance 
with FDA regulations.  
 
For further information on this process, contact an appropriate DoD laser safety 
representative. 
 
US Army Center for Health Promotion and Preventive Medicine
ATTN:  MCHB DC-OLO
Aberdeen Proving Ground, Maryland  21010-5422  
Commercial (410) 436 3932  
 
Naval Surface Warfare Center, Dahlgren Division
Code G73
17320 Dahlgren Road, Dahlgren, VA  22448-5100
Commercial (540) 653-1060/1149
 
Air Force Research Laboratory 
Human Effectiveness Directorate; Optical Radiation Branch
711 HPW/RHDO
4141 Petroleum Rd
Fort Sam Houston, TX 78234
Phone: (210) 539-2375
Email: 711HPW.RHDO.USAFLaserSafety@us.af.mil  
 
 
 
Getting More Information  
You can get more information about our requirements for lasers from our electronic 
product radiation control web page at http://www.fda.gov/cdrh/radhlth/. 
 
If you have questions about this guidance, contact Jerome Dennis, CDRH, Office of 
Communication, Education and Radiation Programs, 10903 New Hampshire Avenue, 
Silver Spring, MD 20993, Rockville, MD 20850, FAX 301-594-4672, or 
e-mail jxd@cdrh.fda.gov. 
 
Sincerely yours, 
 
 
 
Phillip J. Frappaolo 
Acting Director 
Office of Compliance 
Center for Devices and Radiological Health 
4