FDA has updated and published its Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (05/12/2016). The guidance document is consistent with the agency’s good guidance practices regulation, 21 C.F.R. § 10.115.
FDA published earlier versions of the guidance document in May 1997 and May 2007. This guidance is a second edition of the May 2007 guidance document. It finalizes a draft guidance document, the availability of which was announced in the Federal Register of August 13, 2013 (78 Fed. Reg. 49,271).
This Second Edition of the guidance document provides responses to additional questions regarding the definition and labeling of medical foods, and updates some prior responses. It is intended to provide industry with a convenient place to find answers to frequently asked questions about medical foods, and represents the current thinking of FDA on this topic.