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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
Final
Docket Number:
FDA-2013-D-0880
Issued by:
Guidance Issuing Office
Human Foods Program

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

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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
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0880.

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