Sponsor-Investigator Program

When is submission of an Investigational New Device application required?

Most investigations of drugs or biological products require submission of an Investigational New Drug (IND) application to the FDA.

  • If the study involves a drug used in humans in any way other than in the course of medical practice, an IND is required unless certain exemptions apply.
  • Exemptions are some investigations of already approved drugs, some studies using diagnostic biological products and in vitro drug tests, and some bioavailability or bioequivalence studies.
  • For additional background, see the FDA’s regulations . A study that is exempt from the IND requirement must still comply with FDA requirements for IRB review and informed consent.

When is an Investigational Device Exemption application required?

When the principal intent of the medical device (or other product regulated as a device) is to develop information about the product’s safety or efficacy, submission of an IDE application is ordinarily required. In certain circumstances, however, the FDA does not require an IDE.

  • Investigations of devices fall into one of three categories:
    • Exempt from IDE requirements
    • Studies of nonsignificant risk devices subject to abbreviated IDE requirements
    • Significant risk devices subject to full IDE requirements.
  • A study that is exempt from the IDE requirement must comply with FDA requirements for IRB review (same link as above) and informed consent (same link as above).

The summaries linked below will guide you in determining responsibilities.

FDA forms, regulations, and guidance documents

Need Help?

Indiana CTSI Project Manager - Regulatory Knowledge and Support
Email: csego@iu.edu
Phone: 317-274-2115

Quality Improvement Office
Email: researchcompliance@iu.edu