FDA Guidance for Medical Food

Guidance for Industry Frequently Asked Questions About Medical Foods; Second Edition Draft Guidance

August 2013

Frequently Asked Questions About Medical Foods 

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods.

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. 

Dr. David Lim provides regulatory consulting services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS).