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MEMORANDUM

Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) August 1976

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

The purpose of this memorandum is to notify all laser product manufac­turers of an exemption granted for all laser products which are manu­factured after August 2, 1976, and used exclusively by DOD agencies, and which are designed for actual combat or combat training operations or  are classified in the interest of national defense (Reference FDA Docket No. 76P-0335).  The exemption does not apply to laser products intended primarily for use in indoor classroom training and demonstration, industrial operations, and scientific investigations; and medical laser products. The exemption is from the FDA performance standard for laser products in 21 CFR Part 1040.10 and 1040.11 and the associated reporting and record keeping requirements of 21 CPR Part 1002, except for paragraph 1002.20 relating to accidental radiation occurrences.

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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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Food and Drug Administration
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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