Sponsor-Investigator Responsibilities for IDE
Investigators who initiate and submit an IDE application to the FDA assume the responsibilities of both the investigator and the sponsor. Under FDA regulations, an academic sponsor or sponsor-investigator has the same obligations as a multi-national device manufacturer that sponsors or holds an IDE. This form is for Sponsor-Investigators to conduct a self-assessment of their IRB approved studies to ensure that they are meeting their institutional and regulatory requirements.