Where to Begin

Not every study involving a drug or device must be conducted under an Investigational New Drug (IND)/Investigational Device Exemption (IDE) Application. Unsure if your study might be FDA regulated?  Please read  theguidance below and email IIS@pitt.edu if you have questions.

Investigational New Drug (IND) Application

An FDA-accepted IND application is required to conduct human studies using the following:

  • Unapproved drug or biologic
  • Some legally marketed drugs are being used off label*
  • Dietary Supplements used to treat, diagnose, cure, mitigation, or prevention of disease.  Note that dietary supplements although legally marketed are regulated as foods, not drugs.
  • Any other article that meets the FDA’s definition of a drug, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; and articles (other than food) intended to affect the structure or any function of the body

If an investigator believes the study is exempt from the FDA requirements for needing an IND for the off-label use, with appropriate justification provided to the IRB based on the IND exemption criteria, a decision may be made by the IRB that the study can be conducted without an IND.  If the reviewing IRB is unsure whether the study can be conducted without an IND, they can require that the investigator submits to the FDA for a determination.  The FDA determination is binding.

For additional information, refer to the FDA Guidance Document, Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.

Investigational Device Exemption (IDE) Application

An FDA-accepted IDE application is required to conduct human studies using the following:

  • Unapproved Significant Risk (SR) medical device (including in-vitro laboratory assays and digital health technologies) being evaluated for safety or effectiveness.
  • A legally marketed SR medical device used off-label and being evaluated for safety or effectiveness.

Note that the risk determination of the medical device (Significant versus Non-significant Risk) is an important regulatory consideration and dictates whether compliance with the full or abbreviated IDE regulations is required.  

If an investigator believes the medical device is non-significant risk (NSR), with appropriate justification provided to the IRB based on the NSR criteria, a determination may be made by the IRB.  If the reviewing IRB is unsure of the determination, they can require that the investigator submits to the FDA.  The FDA determination is binding.

For additional information, refer to FDA Guidance.