Business · 18/07/2013Updated: 10/17/2026 · 1 min read

FDA Guidance on Fecal Microbiota Transplantation for C. difficile Infections

The Food and Drug Administration (FDA) has released a guidance document outlining its enforcement policy for the use of fecal microbiota transplantation (FMT) to treat Clostridium difficile infections that are not responsive to standard therapies. The policy, which was first announced in July 2013, allows treating physicians to obtain informed consent from patients before using FMT products, provided that the consent includes a statement about the investigational nature of the treatment and its potential risks.