Maintaining an IND or IDE

June 23, 2026

In this post, we will discuss maintaining your Investigational New Drug (IND) or Investigational Device Exemption (IDE) with the FDA after you receive permission to begin your study.

Remember that all FDA submissions and correspondence must also be submitted to the UMN Central File via submission form.

Amendments

Immediate amendment submission

If changes to any study materials or FDA forms meet any of the following criteria, you must submit an amendment to the FDA immediately:

Drugs (21 CFR 312.30(b)):

Significantly affects the safety of subjects
Significantly affects the scope of the investigation
Significantly affects the scientific quality of the study

Devices (21 CFR 812.35(a)(4)):

Significantly affects the validity of the data or information resulting from the completion of the approved protocol
Affects the relationship of likely patient risk to benefit relied upon to approve the protocol
Affects the scientific soundness of the investigational plan
Affects the rights, safety, or welfare of the human subjects involved in the investigation

Amendments that do not meet these criteria can be saved and submitted with your next annual report. When in doubt, submit an amendment to be safe.

Do you need to wait for FDA approval?

Drugs (21 CFR 312.30(b)(2)(i)):

You may implement your changes as soon as both of the following conditions are met, in either order:

The changes have been submitted to the FDA
The changes have been approved by the IRB

Devices (21 CFR 812.35(a)(1)):

You may implement your changes as soon as both of the following conditions are met, in either order:

The changes have been approved by the FDA
The changes have been approved by the IRB

Annual reports

Annual reports are due each year, on the anniversary (±60 days) of the date that the original IND or IDE went into effect.

What must be included:

Drugs (21 CFR 312.33):

Study title and identifiers
Study purpose
Study population
Study status (enrolling, completed, etc)
Participant enrollment:
- Age, gender, race of those enrolled
- Status of participants (on treatment, completed, dropped out, etc.)
- Causes of any participants deaths or withdrawals
Brief summary of any interim or final results
Summary of frequent or serious adverse events by body system
Summary of any IND safety reports from the past year
Description of any updates about drug action, preclinical studies, manufacturing changes, or foreign marketing developments from the past year
Description of study plans for the coming year
Any revised documents not previously submitted to the FDA, including:
- Protocol
- Consent
- Investigator’s brochure/ package insert

Devices (21 CFR 812.150(b)(5); FDA Guidance):

Study identifiers and contact information
Summary of study progress, including:
- Number of investigators and sites
- Number of participants enrolled
- Number of devices shipped
Brief summary of any interim or final results
Summary of adverse events, whether or not they were anticipated
Summary of any deviations from the plan since the last annual report
Description of any updates about the device, preclinical studies, manufacturing changes, or foreign marketing developments from the past year
Copy of any publication from data collected from this study
Any revised documents not previously submitted to the FDA, including:
- Protocol
- Consent
- Device manual
Description of study plans for the coming year, including plans for submission for PMA or 510(k)

Safety reporting

Drugs (21 CFR 312.32(c)(1)):

The following events must be reported to the FDA as soon as possible, but no later than 15 calendar days after determining a report is necessary:

Serious and unexpected suspected adverse reaction
Findings from other studies (both human and preclinical) that suggest a significant risk to humans exposed to the drug
Increased rate of occurrence of serious suspected adverse reactions

All IND safety reports may be submitted via FDA Form 3500 or via the FDA’s Safety Reporting Portal.

Devices (21 CFR 812.150(b)):

The following events must be reported to the FDA as soon as possible, but no later than the time frame listed below:

Unanticipated adverse device effects: Within 10 business days of first notice of effect
Withdrawal of IRB approval: Within 5 business days after receipt
Recall and device disposition: Within 30 business days after request to return, repair, or dispose of a device
Use of a device without informed consent: Within 5 business days of first notice

Device safety reports may be submitted via FDA Form 3500 or via the FDA’s Safety Reporting Portal. Other IDE reports may be submitted via CDRH’s Customer Collaboration Portal.

Expert support

Need help with your IND or IDE? The Clinical Research Support Center has experts to guide you:

Clinical Research Support Center

[email protected]
612-625-4000

IRB submission support, ClinicalTrials.gov registration support, and IND/IDE submission support and guidance may be requested through the Clinical Research Support Center.

Complex FDA guidance or official IND/IDE category determinations may be requested through the University’s Human Research Protection Program (HRPP) available at: [email protected].

Don’t know where to start? Contact the Clinical and Translational Science Institute's Research Navigator:

Research Navigator

[email protected]
612-625-CTSI (2874)

Maintaining an IND or IDE

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