University of Minnesota  FAQ

University Sponsor and Sponsor-Investigator IND/IDE and FDA Pre-Submission Requirements


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Please use the contact section in the governing policy.

  1. Who can help me understand IND and IDE regulations? What are my obligations as a sponsor-investigator?

    IND regulations can be found in 21 CFR 312, and IDE regulations can be found in 21 CFR 812. If you have questions or need help interpreting these regulations, please reach out to either CTSI’s Regulatory Hub or HRPP’s MedReg. There is practical information about investigator responsibilities in ICH GCP E6, Section 4; and sponsor responsibilities in ICH GCP E6 Section 5.

  2. Who can make a Non-Significant Risk determination?

    IRB and/or FDA makes the final risk level determination. A non-significant risk determination assessment is made by the HRPP MedReg ancillary review for IRB review and final determination (unless the FDA has already made the final determination). The CRSC Feasibility Review can give you a good idea if your study meets these criteria prior to submission, or you can request a consultation with HRPP’s MedReg.

  3. Is my product a drug, device, or biological product?

    The FDA definitions for these product types can be found at Drugs@FDA Glossary of Terms.

  4. Are the contents of my IND or IDE application sufficient?

    Consultations about the content of your FDA application are available from the CTSI Regulatory Hub. One hour of free consultation time with regulatory experts may also be available by request to HRPP’s MedReg.

  5. Do I need an IND and/or IDE for my research?

    CTSI’s Regulatory Hub can help decide whether an FDA submission is needed for your study. For cancer research, the Masonic Cancer Center’s CTO can assist you. Complicated studies may be escalated to HRPP’s MedReg for consultation.

  6. Who can help me submit to the FDA?

    FDA submission support is available from CTSI’s Regulatory Hub. Please note that FDA submissions for the Masonic Cancer Center are handled by the cancer center’s Clinical Trials Office. You can also seek support from private Contract Research Organizations or Consultants if your budget permits.

  7. Who can help me prepare for meetings with the FDA?

    CTSI’s Regulatory Hub can help request a meeting with the FDA and can submit questions and information in advance of your FDA meetings. For cancer research, the Masonic Cancer Center can assist you. Investigators are responsible for their own scheduling, agendas, and meeting minutes.

  8. Who can help me with my IRB submission for my drug or device study?

    CTSI’s regulatory specialists can help you with your IRB submissions. Some departments already have specialized regulatory support to which you may be redirected if applicable.

  9. Can anyone help me prepare for an upcoming FDA inspection?

    CTSI’s internal monitors can help guide investigator-initiated studies through preparation for an FDA audit.

  10. What documents need to be submitted to the IND/IDE Central File?

    To submit document to the IND/IDE Central File Form Submission, email your documents to: [email protected]

    For each new protocol, whether Non-Significant risk IDE, Significant Risk IDE or IND or an FDA pre-submission, Sponsors and Sponsor-investigators must submit the following to the University’s IND/IDE Central File (Central File Online Submission Portal), as applicable:

    • IND/IDE exemption or determinations requests
    • IND/IDE pre-submission and application
    • Safety reports
    • Amendments
    • Communications, including transcriptions of calls with the FDA
    • Annual report(s)