Full course description
The conduct of a clinical investigation (i.e., clinical trial) under an FDA-Regulated Investigational Device Exemption (IDE) application includes a complex set of FDA regulations, requirements, and obligations. The FDA holds the sponsor of the IDE application responsible for ensuring that all of the regulations, requirements, and obligations are being met (21 CFR Part 812, Subpart C). Although sponsors of IDE applications are typically pharmaceutical and device companies, the FDA regulations governing IDE applications permit the sponsor to be an individual, governmental agency, or academic institution (21 CFR Part 812.3).
The purpose of this standard operating procedure is to:
- help determine when an IDE is required,
- provide guidance and resources to individuals conducting a clinical investigation, who may be sponsor-investigators, on obtaining an IDE for the device under study, and
- address the process for compassionate use (also referred to as expanded access) and emergency use of an investigational device.