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GUIDANCE DOCUMENT

Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products Guidance for Industry and FDA July 2002

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

 
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