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Investigational Drugs and Devices

Investigational New Drug (IND) Application

An IND application is the document submitted to the Food and Drug Administration (FDA) for permission to conduct a clinical investigation using a drug or biological product that is new or not approved for that dosage, form, or indication.

An investigator is always required to submit an Investigational New Drug (IND) application to study an unapproved (i.e., not commercially available in the U.S.) drug or biologic.

An investigator may be required to submit an IND application to the FDA to study a marketed drug or biologic in a new (i.e. unapproved) clinical indication.

In both cases, the products are considered “investigational” by the FDA.

How to Determine if an IND Application is Needed

Review the following true or false statements. If the answer to any of the statements below is “true”, you will need to submit an IND application to FDA.

  1. The drug used in the investigation is not an FDA-approved, marketed drug.
  2. The investigation is intended to be reported to the FDA as a well-controlled study in support of a new indication or a change in labeling.
  3. The investigation is intended to promote or commercialize the investigational drug.
  4. In the case of prescription drugs, the investigation is intended to support a significant change in advertising for the drug.

The study involves changing the route of administration (e.g., oral to IV), dosing, population (e.g., from adults to children), or other factor that significantly increases (or decreases acceptability of) participant risk.

Preparing an IND Application

The documents needed to prepare an IND include:

  • Form FDA 1571 (IND Application) or a dossier addressing all of the elements outlined in Form 1571 must be submitted by the sponsor or sponsor-investigator.
  • Form FDA 1572 (Statement of Investigator)
  • Form FDA 3674 (Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank)
FDA IND Regulations and Guidance

Investigational New Drug Application: Title 21 Code of Federal Regulations Part 312

Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

Determining Whether Human Research Studies Can Be Conducted Without an IND – FDA Guidance (2013)

Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators – FDA Draft Guidance (2015)

Forms and Instructions for IND (FDA)
Guidance on Form 3674

Vaccines, Blood, and Biologics

Guidance on IND Safety Reporting

Investigational Device Exemption (IDE)

An Investigational Device Exemption (IDE) application is the document submitted to FDA to allow for the conduct of a clinical investigation using an investigational device (an unapproved device or a new intended use of an approved device) that poses a significant risk to the study participant.

Determining if an IDE Application is needed

An IDE is required if the study involves a significant risk device. A significant risk device is an investigational device that:

  1. Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a participant;
  2. Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a participant;
  3. Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a participant; or
  4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a participant.
IDE Exempt Investigation

IDE Exempt Investigation

The FDA may determine that your study is exempt from FDA regulation. However, the study is still subject to IRB regulation.

FDA IDE Regulations and Guidance

Investigational Device Exemptions:  Title 21 Code of Federal Regulations Part 812

FDA Guidance: “Decisions for Investigational Device Exemption (IDE) Clinical Investigations”

Complying with USC Educational Requirements

In addition to federal and state requirements, USC IND or IDE holders must comply with applicable USC educational training requirements.

Additional FDA Guidance and Resources

FDA Guidance on Financial Disclosure by Clinical Investigators

FDA Reporting Requirements for IND/ IDE and Biologics

FDA Guidance on Sponsor-Investigator/IRB Interrelationships
Monitoring Guidance for Holders of IDE/IND

“Working with Pharmaceutical Companies on Investigator-Initiated Clinical Trials” (Journal of Clinical Research Best Practices)

Regulatory Documentation for IND Studies

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