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          Conducting Remote Regulatory Assessments Questions and AnswersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Conducting Remote Regulatory Assessments Questions and Answers
		 
			Draft Guidance for Industry
		
		January 2024


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2022-D-0810
	    	    		    Issued by:
		    Guidance Issuing Office
          Office of Regulatory Affairs


The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments (RRAs) in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs and help maximize compliance of FDA-regulated products. This draft guidance provides answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.

This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Conducting Remote Regulatory Assessments.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.


 
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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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						All written comments should be identified with this document's docket number: FDA-2022-D-0810.



  
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                                                                                  Content current as of:
      01/26/2024
         
                  
Regulated Product(s)
		 Animal & Veterinary
			  			     			  			     Biologics
			     			  			     Cosmetics
			     			  			     Dietary Supplements
			     			  			     Drugs
			     			  			     Food & Beverages
			     			  			     Medical Devices
			     			  			     Radiation-Emitting Products
			     			  			     Tobacco
			     			  						              
						  Animal Food Additives
			  			     			  			  
			 
			  Allergenics
			  			     			  			  
			
			
						  Generic Drugs
			  			     			  			  
						  Juice
			  			     			  			     Seafood/Seafood Product
			     			  			  
			  
			  Anesthesiology
			  			     			  			     Cardiovascular
			     			  			     Dental
			     			  			     Ear, Nose & Throat
			     			  			     Gastroenterology-Urology
			     			  			     General & Plastic Surgery
			     			  			     General Hospital & Personal Use
			     			  			     Immunology & Microbiology
			     			  			     Molecular and Clinical GeneticsTopic(s)
			  Premarket
				    				       				    				       Compliance
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				  Bioequivalence
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				     				  				     Pharmaceutical Quality
				     				  				  
				   
				  Allergens
				  				     				  				  
				  				  510(k)
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