Meeting Reporting Requirements
The U.S. Food and Drug Administration (FDA) considers stool for FMT an investigational drug, a classification that carries certain reporting requirements. We aggregate and share your submissions to our material tracking program with the FDA. Adherence to OpenBiome’s follow-up reporting protocol is required for continued access to FMT.
Follow-Up Reporting Instructions
Below, we have shared a follow-up reporting checklist for FMT preparations manufactured by the University of Minnesota (UMN) and OpenBiome as well as instructions for reporting an Adverse Event.
Reporting Checklist for FMT Manufactured by the University of Minnesota (UMN)
Reporting Checklist for FMT Manufactured by OpenBiome
Reporting an Adverse Event
If you suspect that one of your patients has experienced an adverse event that could be related to an FMT treatment distributed by OpenBiome, please fill out and submit OpenBiome's online Adverse Event Reporting Form within 24 hours to alert our Clinical Safety Team.
Please review the checklist on the fourth page of our Adverse Event Reporting Guide to ensure that you have the necessary information ready to complete your report. Once submitted, an OpenBiome medical professional will contact you to discuss the specifics of your case and advise whether additional reporting requirements to the FDA may be needed.
Thank you for enabling OpenBiome’s mission of serving patients in need, as well as proactively monitoring the efficacy of FMT treatments manufactured by the University of Minnesota on a network-wide and per-donor basis.
The safety and efficacy data you provide will be used to optimize treatment for patients and inform the design of future microbiome-based therapies.