Military Laser Products: Department of Defense Exemption Requirements and Compliance Process
This guidance clarifies the conditions of FDA exemption no. 76EL-01DOD granted to the U.S. Department of Defense (DoD) for laser products used in combat, combat training, or classified for national security reasons. It explains the process and requirements for manufacturers to obtain and maintain DoD exemptions from the FDA Performance Standard for Laser Products.
Recommended Actions
- Establish process to obtain DoD exemption letters before marketing any military laser products
- Implement documentation system to maintain exemption letters and track their scope/limitations
- Create compliance checklist combining applicable FDA requirements and DoD safety specifications
- Develop clear labeling system for exempt products
- Establish procedure for product modifications requiring new exemption letters
- Create process to ensure exempt products are not sold outside DoD
- Maintain contact with appropriate DoD laser safety representatives
- Train sales team on restrictions and requirements for military exempt products
- Implement verification process to ensure all “military exempt” products have proper documentation
Key Considerations
Labelling
- Exempt DoD laser products must be clearly identified through labeling
- Products cannot be falsely labeled as “military exempt” without written DoD exemption letter
Safety
- Laser product specifications must include safety features required by FDA standard to the extent practicable
- Safety controls specified by DoD must supplement product specifications
- Products may be exempted from specific safety features (like warning lights) when inappropriate for combat use
Other considerations
- Manufacturers must obtain written exemption letter from authorized DoD procuring agency before sale
- Exemption letter must be retained for subsequent sales to any DoD agency
- New exemption letter required for any product modifications
- Exempt products cannot be sold outside DoD unless brought into full FDA compliance
- Violation of Federal law if selling non-compliant laser system without exemption letter
Relevant Guidances
- Laser Products - Performance Standards and Safety Requirements
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
Related references and norms
- 21 CFR 1040.10 and 1040.11: Federal Performance Standard for Laser Products
Original guidance
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