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          Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25)Search for FDA Guidance Documents MEMORANDUM
	Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25)
					
		
		September 1979


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    PrintDocket 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 exemptions granted for laser products intended for U.S. Government use (21 CFR 1010.5).  These laser products may not be the same as models that are certified and sold or leased commercially. They are to be used exclusively by (1) the National Oceanic and Atmospheric Administration, U.S. Department of Commerce or by (2) the Department of Energy or by its contractors at DOE designated, government-owned contractor-operated (GOCO) facilities in unique research applications or as components in larger research and development systems. The exemption is from the FDA performance standard for laser products, 21 CFR 1040.10 and 1040.11, and the associated reporting and recordkeeping requirements, 21 CFR Part 1002, except for paragraph 1002.20 relating to accidental radiation occurrences.


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

                                                                                  Content current as of:
      08/24/2018
         
                  
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