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          Guidance for Industry: Frequently Asked Questions About Medical Foods - Third EditionSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition
					
		
		March 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2013-D-0880
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods. The responses to these FAQs address common questions about the definition of and regulations for medical foods. This guidance is a third edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.”

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should* in agency guidances means that something is suggested or recommended, but not required.

**Download the Guidance**

Related Information

Medical Foods Guidance Documents & Regulatory InformationSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
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							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2013-D-0880.

                                                                                  Content current as of:
      03/15/2023
         
                  
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