Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition


How to Comment

The comment period opens May 13, 2016.

Submit electronic comments on to docket number FDA-2013-D-0880.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2013-D-0880.

Contains Nonbinding Recommendations

May 2016

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 second edition of the May 2007 guidance titled “Guidance for Industry: Frequently Asked Questions About Medical Foods.”

This guidance provides responses to additional questions regarding the definition and labeling of medical foods and updates some of the prior responses.

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 Guidance for Industry (PDF 170KB)

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