Regulatory Oversight of Fecal Microbiota Transplantation (FMT): Consideration for Treating Clinicians

Fecal microbiota transplantation (FMT) follows a unique model of federal oversight in the United States. Although the U.S. Food and Drug Administration (FDA) considers FMT an investigational new drug, physicians may use FMT to treat patients with recurrent C. difficile infection under the agency’s policy of “enforcement discretion.” This document provides answers to frequently asked questions regarding the regulation of FMT, with an emphasis on the U.S. context.