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          Identification Labels for Certain Class I Laser Products (Laser Notice 48)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Identification Labels for Certain Class I Laser Products (Laser Notice 48)
					
		
		September 1996


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2020-D-0957
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health


The regulations for electronic products require each electronic product for which a standard has been promulgated to be identified with the name and address of the manufacturer (21 CFR 1010.3}. This identification is to be on a tag or label permanently affixed to the product. Identification of the product is required so the product may be traced for recall in the event there is a defect in the product or the product is found to be noncompliant. This requirement is applicable to all laser products certified as complying with the Federal performance standard for laser products, 21 CFR 1040.10 and 1040.11.


 
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                                                                                  Content current as of:
      08/24/2018
         
                  
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