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          Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart CSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C 
					Guidance for Industry and FDA Staff
		
		February 2019


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2016-D-3548
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of Regulatory Affairs
          Center for Veterinary Medicine
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Tobacco Products


The purpose of this guidance is to assist and provide recommendations to industry and FDA staff regarding the use,content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance also discusses what information should be included in a public warning, as well as the parties responsible for issuing it. It represents FDA’s current thinking on public warning and notification of recalls under 21 CFR Part 7.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR Part 1240. However, it does not apply to radiation-emitting electronic products, which are governed only by 21 CFR Parts 1003 and 1004.


 
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						All written comments should be identified with this document's docket number: FDA-2016-D-3548.



  
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                                                                                  Content current as of:
      02/08/2019
         
                  
Regulated Product(s)
		 Animal & Veterinary
			  			     			  			     Biologics
			     			  			     Drugs
			     			  			     Food & Beverages
			     			  			     Medical Devices
			     			  			     TobaccoTopic(s)
			  Recalls
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