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The following information is intended to provide sponsor-investigators with information to guide them through the FDA requirements for sponsor-investigators who hold an IDE. The federal regulations for IDEs are found under 21 CFR 812. For more information, review the FDA’s Center for Devices and Radiologic Health (CDRH) web site here.
This is a synopsis of requirements specific to sponsor-investigators who hold IDEs. It is intended to be a guide, but does not include the complete text of the regulations. Hyperlinks for the corresponding regulations are included throughout this section. Sponsor- investigators must review and be familiar with the federal regulations before undertaking these responsibilities.
Sponsor-investigators are also required to follow all federal regulations and University of Iowa policies and guidance for Human Subjects research, and VAHCS requirements as applicable.
A Sponsor-Investigator is an Investigator holds an IDE for the product being tested in a particular research study, he/she must also assume the role of the Sponsor, and is called a “Sponsor-Investigator.” The FDA defines a Sponsor-Investigator as “an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used . . . . The obligations of a sponsor-investigator under this part include those of an investigator and a sponsor.”