Fecal Microbiota Transplantation

Transforming lives through innovative fecal microbiota transplantation for various medical conditions and improved gut health.

Regulations Governing Investigational FMT

Overview

Investigational Fecal Microbiota Transplantation (FMT) preparations distributed by FMT-Life are regulated under the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application. These regulations ensure that investigational FMT treatments are used safely and effectively in clinical settings for patients with specific medical conditions.

Key Regulatory Aspects

1. FDA IND Application:

   • Approval Process: FMT-Life distributes investigational FMT preparations manufactured by the University of Minnesota under an FDA-reviewed IND application. This process involves rigorous review and approval by the FDA to ensure the investigational FMT meets safety and efficacy standards.

   • Compliance: All investigational FMT treatments must comply with the FDA’s IND regulations, which govern how investigational drugs are used in clinical research and practice.

2. Physician Registration:

   • Eligibility: Physicians must be registered with FMT-Life’s Clinical Network to order investigational FMT. This registration confirms that the physician is authorized to use investigational treatments and is familiar with the regulatory requirements.

   • UMN-Specific Registration: Physicians must also complete a University of Minnesota (UMN)-specific registration form to access UMN-manufactured FMT preparations.

3. Patient Eligibility:

   • Recurrent Infections: Patients must have recurrent C. difficile infections that have not responded to standard therapies. Eligibility criteria are outlined by the FDA IND guidelines and must be evaluated on a case-by-case basis.

   • Medical Review: Physicians must review each patient’s medical condition and history to confirm eligibility for investigational FMT.

4. Informed Consent:

   • Patient Consent: Prior to administering investigational FMT, physicians must obtain informed consent from the patient. This involves providing detailed information about the investigational treatment, potential risks, and benefits.

5. Reporting Requirements:

   • Adverse Events: Physicians must report any adverse events or side effects experienced by patients during or after the treatment. These reports are submitted to FMT-Life and the FDA to monitor safety and efficacy.

   • Compliance Reports: Physicians and facilities must adhere to regular compliance reporting as required by the FDA to ensure ongoing oversight and regulatory adherence.

6. Shipping and Handling:

   • Temperature Control: Investigational FMT preparations are shipped using secure, temperature-controlled methods to preserve their efficacy. Compliance with shipping regulations is crucial to maintaining the quality of the preparations.

7. Documentation and Record-Keeping:

   • Order Records: Detailed records of all orders and patient treatments must be maintained. This documentation is necessary for regulatory compliance and monitoring the effectiveness of investigational FMT.

Additional Resources

For more information on regulatory requirements and guidelines for investigational FMT, please refer to the following resources:

• FDA IND Application Information

• University of Minnesota Clinical Research Information

• FMT-Life Clinical Network Registration Instructions

For questions or assistance regarding regulatory compliance, please contact our support team at info@fmt.life or 617-575-2201.

This section provides a comprehensive overview of the regulatory framework governing investigational FMT, ensuring that all stakeholders are informed about the necessary compliance requirements.